GNBT: Another Patent, an Abstract and a One Dollar Share Price?

Generex Biotechnology Corp. announced on Tuesday that it had been awarded a new patent in Canada for its proprietal buccal drug delivery system, the same system used in Oral-lyn, an insulin spray that is nearing the end of a Phase III trial. Using this delivery system, insulin is absorbed through the inner lining of a patient's cheek.

The new patent adds to an already hefty patent total for the still developing company and covers the method for preparing pharmaceutical compositions and methods for enhancing the rate of absorption, according to
Tuesday's press release.

The news of another awarding of a patent for Generex is a positive development, although not expected to have any impact on the share price, but what should be considered a significant event was the abstract presented at the 46th Annual Meeting of the European Association for the Study of Diabetes last week in Sweden.

The abstract, titled 'No Generation of Insulin Antibodies in Subjects with Impaired Glucose Tolerance Treated With Buccal Spray Insulin,' is self-expanatory and is a highly significant and relavent piece of information when calculating the potential of Oral-lyn on the market.  The fact that no insulin antibodies appeared in patients using Oral-lyn

With the recent run stalling at the half-dollar mark, shareholders will be glued to the wires awaiting the next piece of information release that could send GNBT flying towards the one dollar mark - the price where the stock needs to be to ward off a reverse split once and for all.

Considering the sales and growth potential of Oral-lyn - once approved as a needleless alternative for delivering insulin - GNBT could be the bargain of the year right now, similar to DNDN before Provenge Phase III results came rolling in. 

One Seeking Alpha blogger did a fine job assessing the risk/reward potential of Generex over the coming months, and also broke down the above mentioned Oral-lyn abstract for followers of the company.

Every day is a day closer to the realization of potential for Oral-lyn, and GNBT should be one of the most hotly-watched stocks over the next couple of months.

Stay tuned.

Disclosure:  Long GNBT.

Readers Respond: BIEL

A comment from a reader of VFC's Stock House page on Seeking Alpha:

I noticed that you follow BIEL. I would like to know if it is a scam. I can't understand why a life or death drug gets approved in 3 to 6 months and there electronic bandaid has yet to get a responce in over a year. It is being used in plastic surgery, been proven safe and effective, and seems to have good global sales. I am an amatuer at this, but it seems that this sould have been approved a long time ago. Any insight as to this companywould be greatly appreciated.
David




VFC's Take: I'll address this one point-by-point.  BioElectronics has been the target of many attacks in cyber space over the past year, some of which question the company's legitimacy and even its very
existence. It's difficult, however, to consider a company that already has products selling on the international market a scam, especially when the products are gaining traction and distributorship on a signficant scale.

Regarding the 'life or death' drugs, those drugs should have priority over devices such as ActiPatch. Saving lives is what it should all be about in this sector - although we know that money often trumps moral - and drugs that save lives cannot be compared to 'convenience' products. The FDA also grants designations to certain drugs, such as Fast Track Status or Orphan Drug Status to hasten the timeline to approval. Those designations would simply not apply to a product like Allay or ActiPatch.

That said, I agree that there is no excuse for the FDA not having come to a decision in such a long period of time. The product is effective, provides a safer alternative to Tylenol and Ibuprofen - both of which are proving to have negative long term effects on the liver and kidney, respectively - and is already being used in the healing process for plastic surgery. It would seem that there's plenty of information out there to support the company's claims of safety and efficacy, but the biggest hurdle with BioElectronics, in my opinion, is beating the 'little guy syndrome.'

There's no doubt in my mind that if BIEL's products had been developed and marketed by a big player in the pharmaceutical market, or if the products were not in competition with big pharma, then they would have been approved long ago. While the FDA advertises itself as an apolitical organization, we all know that there is nowhere more political than Washington, DC, and those guys know the hands that feed them; in this case, the hand is big pharma. For years it's been a big struggle for the little guys in this sector to become successful. It's difficult enough for a small pharma or biotech to survive as it is just due to the rate of failure in the sector, but the FDA's love affair with big pharma is also a roadblock. What's ironic about this situation is that the little guys are working on cures and preventative medicines, while the big boys are working on treatments - because that's where the money is. Let's say it again - the big players want to treat you, not cure you. There's no money in a cure. A cure is a one-time payment, while treatment is a lifetime contract. They want you popping pills and heading to the clinic until you keel over.

Getting back to the subject at hand, BIEL's main problem right now is being a small player in a huge market dominated by the big boys. I'm a believer that good products will eventually win, but it takes time.

Dendreon's Provenge is a ground-breaker for cancer treatment, but look how long it took the FDA to approve that product? And during the course of the approval timeline, the Provenge saga was marred with financial conflicts-of-interest by FDA advisory board members and an obvious bias against the product and the company by the media, the markets and - it could be argued - by the FDA itself.

The point is, when a product like Provenge takes a back seat, we can't expect the ActiPatch, a product of a tiny, little known company, to get put on the front burner.

I think that eventually BIEL's products will see their day in the sun - with over-the-counter approval as a class II medical device here in the United States - but that time could come today, tomorrow, next week or next year. Truth is, I'm not complaining too much about the wait because I feel like investors are getting a pretty good deal with the stock right now, at a time when international sales are growing.

Many Americans are not internationally-minded and are ignoring the prospects for growth overseas, and that's a benefit to those who still want to load up now.

BIEL is no different than any other speculative stock, you've got to have patience. Is success a guaranteed eventuality? Of course not, but when this one runs, I think it'll run big in a short period of time.

A few years down the road - assuming US approval - and BIEL's technology could be a big player in a huge market.

Disclosure: Long BIEL.

Brief: Titan's Probuphine Phase III Fully Funded

Titan Pharmaceuticals announced on Tuesday that with the funds available from an Amended Loan and Security Agreement with Oxford Finance Corporation - in combination with those already available via the NIH grant - the Probuphine Phase III trial is now fully funded. 

Titan is planning to present scientific information regarding Probuphine at the International Society of Addiction Medicine Conference on October 6, and continues to expect trial results to be released during the second quarter of 2011.

In the meantime, eyes will be on the sales growth of Vanda's Fanapt, of which Titan receives 8-10% in royalties. 

The news of a fully funded Probuphine trial was met by the market with a positive reaction as the stock price reached an intra day high of over a buck on volume four times the daily norm.

Titan for these prices is a no-brainer, in my opinion, although not quite the no-brainer that it was for a couple of pennies last year. 

Disclosure:  Long TTNP.

Stock Watch: CTSO

Yesterday I wondered if CTSO was a stock ready to run, and today I'll follow up and state that it's a stock that - if nothing else - should be at the top of our watch lists.

This stock ran to over forty cents on pure speculation (and some rabid pumping) nearly a year ago, and with the CytoSorb Phase III trial looking to be in its closing months, another run to those levels would not come as a surprise. 

Tuesday's price action - which was relatively sideways - came with high volume (not huge, but high) once again, and it's looking like this could be a fine example of volume preceding price; although we've yet to see the spike in price.

Since there's no effective treatment for severe sepsis on the market yet, the burden is on CytoSorbents to prove that it's found the golden egg where everyone else trying to treat the indication came up with a rotten one.  That burden of proof still has doubt attached to it by non-believers, but with crunch time creeping upon us, it's time to take a position one way or another.

This one could be big, but if the Phase III trial is not a success - the potential for big can quickly become a dud; so I'd suggest taking some profit on any speculative spikes before the results are released.

Disclosure:  Long CTSO.

Another Mysterious CELH Dip in Price, Nice Buy and What Does it Mean?

CELH:   In similar fashion to late day trading a couple of Fridays ago, shares of CELH saw a late Tuesday drop in price on volume that doubled the total for the day to that point.  As usual, no news was released in conjunction with the drop, but the Celsius 'get bash crew' - that I believe to be a couple of guys with a whole bunch of IDs - has been working extra hard lately, even putting in quite a few diligent overtime hours over the weekend spreading fear, doubt and discontent about Celsius Holdings in cyberspace.

I emphasize again; if common sense is an indicator, no one would spend this amount of time dedicated to one stock if there was not a sizable financial investment at stake.  It just doesn't happen, especially not in a speculative market.  So don't let these guys fool you, but do take advantage of the buying opportunities that they create.

If there's any doubt that the 'get bash crew' is made up of only a few members, let's look back to a period in March when certain entities were flying around cyberspace trying to impersonate me.  Not only did these guys painfully fail at immitating the real VFC - which an unachievable task anyway because these guys are like school on Saturday - No Class - but  a few of the regular CELH 'get bash crew' member IDs disappeared for a few days.  However, they just added a "2" or a "3" at the end of their new nicknames until their temporary account suspensions for impersonation expired. 

Since the impersonation of VFC came to a stop, so did the appearance of the temporary nicknames these guys had to use. 

Unfortunately, since the impersonation of yours truly by these kids with a whole lot of time and not enough friends on their hands turned into a brutal failure, they like to bring up my name constantly in cyber space - it's bordering on a sick infatuation that they have with myself, and honestly it's a little creepy.  Now don't get me wrong, I can easily understand why they'd be infatuated with me, I'm a dang good looking guy, but creepy is creepy - we're not in high school anymore. 

It's to the point now that I'd have to suggest taking off the Mr. Fantastic underoos and get a life - one that doesn't revolve around VFC.

Back to the price dip, I loved it as a buy and I believe that we're seeing some short covering going on here.  The lightly traded Celsius stock is ripe for the big boys to play it - as I've stated before - and the fact that the 'VFC infatuation crew' have been putting in even more hours in cyberspace than they were before leads me to believe that they are either covering a short position or intend to drive the stock even lower.

Either way,  I think that things are finally coming together with Celsius Holdings.  I'm of the belief that the military, international and domestic growth is all going to translate into nice sales numbers over the next few quarters. 

Decent numbers next quarter would make that two-in-a-row, not a significant event in the big scheme of things, but it'll be huge for the short term  because the big killer of CELH momentum over the past year has been the 'every other quarter' syndrome, where a big quarter was followed by a downturn. 

It's very obvious that the volatility is not over for CELH and it's also obvious that I've got a few creepy individuals falling asleep at night daydreaming about what it's like to be me; but the recent day to day trading has opened some nice buying opportunities and I'm starting to think that the long term potential of the stock could be realized over the short to mid term. 

On a closing note, what's ironic about the 'get bash crew' situation is that these guys are probably drinking four or five cans of Celsius a day to be able to stay up and alert in front of a computer for so long.  Batman & Robin long johns, Celsius and a computer - sounds about right for this crew.

As for the stock - nice buy.

Should be an interesting couple of months for CELH.

Disclosure:  Long CELH.




I

CTSO: Is CytoSorbents Gearing Up For A Run?

Monday morning greeted shareholders of CytoSorbents Corporations with the pleasant news that the company had received an ISO 13485:2003 Full Quality Systems certification, a required milestone for medical devices to be considered for approval in Europe. 

According to Monday's press release, ISO 13485 is an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (E.U.) and clears the way for gaining CE Mark approval for CytoSorb, a treatment for severe sepsis.

The CTSO share price traded up by roughly ten percent on the news, but more noticable was the signficant volume that this news attracting, working out to be nearly ten times the average trading volume.

The CytoSorb trial should be winding down at some point during the fourth quarter, and it's likely that we'll hear the results of the trial during the first few months of next year.  Since a validated and effective treatment for severe sepsis has yet to materialize, CytoSorb could be a golden child for that market, if successful and approved in Europe. 

Expect the company to roll into other countries - including the USA - shortly after an approval decision in Europe, and also expect a huge increase in price if the product is reported to have shown effective results in Phase III and especially if European approval follows.

Recent dilution has tempered expectations of the price spike potential, but a run to fifty cent should be a no-brainer on solid trial results, although I believe that CTSO could blow through the one dollar mark with ease if the buying demand is there.  Over the longer term, the potential for growth is significantly higher.

Investors are still sceptical, I believe, and the stock may trade sideways for a while, but a cautious approach now by the big boys has opened the door for the small investor for the little guy to load up on shares that are going to look Crazy Eddie cheap if this product works out.

Keep it in the back of your mind, however, that there's nothing in the immediate pipeline for CytoSorbents to fall back on if this trial fails - all resources have been directed towards this trial - so it would be a prudent move to take some profits when possible just in case it doesn't work out.

The next six months should be full of excitements and developments for shareholders of CTSO.

Keep an eye on it.

Disclosure:  Long CTSO.

Brief: CVM's Multikine Phase III, Welcome to Russia

After receiving news that the Multikine Phase III trial had received the go-ahead to move forward in Mississippi, Cel-Sci Corp. announced on Monday that the trial will move also forward in the Russian Federation.  Cel-Sci expects to have three clinical centers in Russia.

The CVM stock is still trading with volume well above the norm, but the price run has faltered over the past couple of trading sessions.

Additional approved locations for this trial are likely to roll out through the end of the year and it's possible that interim data could start rolling in by summer of next, if the speed of effectiveness demonstrated by Multikine in the Phase II trial is any indication of what's to come.

Multikine is being tested as a first line treatment for cancer of the head and neck.

Like Oncothyreon's Stimuvax, Multikine could turn Cel-Sci into another Provenge story, if successful.

Cel-Sci is also working on various treatment platforms for its LEAPS technology, including Rheumatoid Arthritis and H1N1. 

Disclosure:  Long CVM.

ONTY: Private Placement Kills Rally

Last week shares of Oncothyreon joined what looked to be a high-volume mini-run among cancer immunotherapy stocks, but that mini rally - at least for ONTY - came to a screaching halt when the company announced a private placement to raise just about $15 million for the cash coffers.

The terms of the placement were very favorable for the investors on the receiving end of the company's shares and warrants, but not so much in terms of current investors, although I in the big scheme of things, this placement is fairly insignificant, especially if Stimuvax turns into a Provenge-like success.

With the stock back to trading in the three dollar range, it's buy time again, but let's not ignore the nearly 7% shares short, as of the last reported count. 

Stimuvax is in the later stages of a final Phase III lung cancer trial, and beyond that the pipeline is loaded with potential.  This potential is not justified by a market cap of under $100 million, in my opinion, and I expect that the stock will rise well to the north side of five bucks before the Stimuvax results are released.  If Stimuvax looks to pass muster with the FDA, then I expect that we'll have another Dendreon on our hands.

It's also worth noting that Merck KGaA is already partnered for this product.

Still watching this one, and adding on the dips.  The recent placement, however insignificant if Stimuvax turns into another Provenge, is worth paying attention to because it looks like a hook-up for whoever was on the receiving end.  Of course, that's all just my opinion.

Disclosure:  Long ONTY.

Readers Respond: GNBT, AVNR, ALXA, VVUS, TGIC

From Ash:

VCF, thanx for your coverage on GNBT. Now with the latest news on approving to adjourn the meeting further - what exactly is going on with GNBT? Have you ever experienced such a thing in the past where shareholders voted twice against a R/S while management is fighting for a 3rd time? What holds them back from scooping up (majority of the) shares for themselves and win the R/S vote?


Can you kindly give your input on any of these -

AVNR (PDUFA date of 10/30/10)
ALXA (PDUFA date 10/11/10)
VVUS (2 year data supposedly o be released this month)
TGIC (it has reached the low of the year - can this go back up)

Thanx you!

ash



VFC's Take:  I'll hit these one by one:

GNBT:  It's still unclear whether the Generex leadership is intent on pushing this reverse split through or if it is posturing to buy time in an attempt to have the share price trading where it needs to be before the Nasdaq moves forward with delisting. 

The company has some time to play with, but it'll take significant news to push the share price higher.  It's definitely been an interesting few weeks for this one, so stay tuned.  It should be an exciting few months for Generex, whether the excitement continues on the Nasdaq or the OTCBB is yet to be seen.

Disclosure:  Long GNBT.



AVNR:  See my recent posting regarding Avanir.

Let's break it down:

The Good:

- Possible approval on the 30th.

- Decent amount of money in the bank to cover expenses for the near term.

The Bad:

- Trend in sector has many stocks dipping after positive approval news.

- Lot of media attention on the stock right now, which could be an indicator that the big boys want you to buy now - and if they want you to buy now, that means that they may want to short the stock later on down the road. The weak hands then sell their shares to those shorts at a lower price.

- FDA may ask for more time.

The Ugly:

- Nothing here is ugly enough to scare me away, but I am a bit sceptical of how the price will react after the decision.

Bottom Line: Don't go crazy at these prices - if the stock runs after positive news, congrats - enjoy. If the price drops post-news, then decide at that point whether to add or not.

Good luck.

Disclosure:  No position.



ALXA:   Alexza expects to hear from the FDA on October 11th regarding an approval decision for AZ-004, a treatment for schizophrenia and bipolar disorder.  Two Phase III trials were successful for the drug, and the recent run in price could indicate that the market is betting on approval.

That said, even if 004 is granted approval in a few weeks, there's a chance that the stock could decline after the approval news in the same fashion that Labopharm did after an FDA approval for Oleptro.  There's still plenty of time to market after an approval, so the big boys can consolidate at a lower price. 

That's not to say that this will happen, but don't be surprised if it does, and definitely protect your investment either way.  This stock has already enjoyed a nice run, so buying now would be 'chasing,' in my book, but I could support a small buy now in case the stock does run post-approval (if it turns out that way), but I'd wait to see what happens from here on out;  if the stock dips at some point over the next couple of months, I'd buy at that point.

The company has long term pipeline potential.  The schizophrenia/bipolar market is huge. 

Disclosure:  No position.



VVUS:  Vivus, Inc. has a robust pipeline based around the potentially lucrative markets of weight loss, sleep apnea, diabetes and erectile dysfunction.  It's long been a habit of mine not to invest in companies that are developing treatments for ED because I believe it's bad kharma, but I'll look at VVUS as objectively as I can.

The stock recently took a hit when an FDA advisory panel recommended against the approval of VVUS's weight loss drug Qnexa because of side effect concerns.  While there is potential that the drug will still receive approval, I'm not willing to take the risk of buying now because with a market cap of over half a billion dollars, I think there's plenty of room for a further drop. 

I'd keep in on the watch list, as I respect the long term potential of the stock, but I think that a buy here is risky; especially at a time when it looks like the FDA wants to crack down on any weight loss products with the slightest of side effects.

There's too much potential that this one could go limp.

Disclosure:  No position.



TGIC:  Yes, this stock has reached the low for the year, but I'm staying away from anything mortgage insurance related right now.  Even though we're hearing from Washington that the recession has been over for a while now (just in time for November elections), the foreclosure crisis is not over just yet.

Not worth the risk/reward in my opinion.

Disclosure:  No position.

Readers Respond: TTNP

From Chad regarding Titan Pharmaceuticals:

VFC,

Do you also find it odd that TTNP has no rise in price even after their recent announcement of a full Phase III go? I guess this news must be different compared to CVM's recent Phase III news? I don't know if you do any technical analysis but RSI indicates to me that the price is stable (I'd like it to be lower though for a buy), that coupled with a near MFI of ~20 tells me we are seeing a possible market bottom. Momentum is also down giving volatility for a price rise. Lastly over the 6 month period, I'm seeing some signs of possible divergence using other indicators in the buyer's favor. Are we seeing a "calm before the storm" like CVM where it took them a good 5 days to see the benefits? 

Thank you
 

 
VFC's Take:   I don't find it necessarily odd that TTNP's price has not responded to any news of late.  I'm one who expects anything in the market, so although I believe that the current trading price is unjustified when considering the potential value of the Fanapt royalties and the future of Probuphine, I don't find it odd.

Considering that TTNP spiked to the mid two dollar range from a penny, I can live with it when consolidation takes place for a buck.  It makes adding shares a no-brainer, just like selling for over two bucks was. 

I'll take the buying opportunities any day.

If the news developments continue to be positive for Titan, and if Fanapt sales continue to grow at a reasonable rate, then TTNP is going to be trading at much higher prices over the next couple of years, barring any unexpected setbacks or irresponsible actions by management.

I'm still convinced that the company may be bought out in the short to mid term future.  Aside from Probuphine and Fanapt royalties, Titan's ProNeura drug delivery technology could be worth a bundle to a large player in the market.

As for the technicals, I am of the belief that the speculative biotech and small pharma sector is one driven more by events than technicals.  I'm not a technical junke.  Some traders live by them, and I respect them, but I believe that events trump technicals in this sector.  I also believe that the technicals can be easily manipulated, especially in lightly traded small and micro caps such as TTNP.

I do give credence to the fact that a relatively lightly traded stock that either hasn't produced or responded to news over a significant period of time could trade more on technicals than one that has traded with volatility based on news.

Titan is a value play right now, in my opinion.  Probuphine just needs some time, but a couple of years down the road should have investors of Titan sitting pretty, if its still a stand-alone at that point and not gobbled up by a large pharma.

Good short, mid and long term potential with this one.

Disclosure:  Long TTNP.

Readers' Picks: MDHI

A comment regarding Medical Alarm Concepts Holding, Inc.:

Hi VFC, Thanks for your insight on several stocks. I follow MDHI, came to my attention through BIEL. Any risk investing at this point in this position as they have the infomercials ready to hit the airways. Looking at the past for similar companies, can we expect a spike in pps.? Not sure if this share is purposely kept low by MM. 

Appreciate your thoughts.





 
VFC's Take:   Medical Alarm Concepts is on the verge of mass distributing it's flagship technology, the MediPendant and follow-on products.  The MediPendant is a personal medical alarm service where the patient can communicate directly with health care providers.
 
The technology is still evolving and Medical Alarm has signed quite a few distribution contracts of late, many with reputable retailers.  The company has also signed YESD as it's DRTV distributor, and the infomercials have already been filmed. 
 
It looks like this company is ready to roll.
 
The prospects for this product are strong, and the stock - while still highly speculative - may enjoy a speculative run with or without the sales numbers to support it, but I have my reservations MDHI and its products.
 
While the idea of having a pendant that a patient could use to easily speak and listen to health care providers or emergency services is a novel convenience, I can't help but wonder how much more this product offers an individual than the everyday cell phone, especially these days with blue tooth headsets.  Today's cell phones and accessories pretty much make life so easy for us that they can text for us, call for us and maybe even pull the toilet paper off the roll for us by just making the simplest of sounds - like "ONE."  There's nothing to it.
 
Therefore, I'm wondering how much the MediPendant will catch on.  Sure, it seems like a novel idea, but are consumers willing to pay extra money to do something that might not give them much more benefit than a cell phone? 
 
There are those with money that may see it as a status, and there are certainly those that will want to have the 'new best thing,' but the jury is out, at least in my opinion, of whether this product is really necessary.  This is relative of the "I've fallen and I can't get up" product line, so there's certainly potential here, but I just don't see anything unique enough to convince me to become a shareholder.
 
It'll be worth paying attention to the next quarterly report, and maybe I'll alter my opinion and outlook at that point, but I think the trading price signifies doubts that the product is for real, especially when last quarter had the company losing four million dollars more than it made (revenue was $561,257).  I believe that the revenues should come in a lot higher than those numbers, but I also get the impression that Medical Alarm is hanging on by a thread, financially - even with the recent announcement that the company's debt was converted to equity.
 
This is a purely 'night on the town' play, if you want in.  Don't be surprised if this company and the product goes nowhere, but if you do hit the jackpot - enjoy it.
 
I'll be on the sidelines wishing all shareholders luck, but I'm not convinced about the product, and I don't buy into companies that I don't feel offer anything that much more unique than what's already out there; especially when it's an additional cost when 10% of the country is still unemployed (even though the White House, right before November elections, is now telling us that the recession has been over for a while now).
 
Good luck.
 
Dislcosure:  No position.
 

Readers Respond: CVM

An email from Roxman1234 regarding Cel-Sci Corp:

WHAT ARE YOUR VIEWS ON CVM SEEMS LIKE YOU PUMPED IT TO THE MAX LAST YEAR
THANKS RICH
 

 
VFC's Take:   As the stock is back in the spotlight with the Multikine Phase III trial underway, I've discussed CVM on numerous occassions over the past few weeks, links provided below:
 
CVM:  Gotta Watch It
Cancer Immunotherapy Picks
Cel-Sci Volume Soars, Price to Follow?
Readers Respond:  CVM
Phase III Commenced in Mississippi
Multikine Phase III on the Way
Readers Respond:  Cels Sci
What's Up With Cel-Sci
 
The recent surge in volume has also raised some eyebrows, drawing attention to the company and stock. 
Nothing has changed regarding my opinion of this company since the last time I posted about it on Wednesday of last week, but it is worth mentioning that TheStreet.com's biotech blogger posted negatively about Cel-Sci in a Friday blog post.  The mention of CVM in TheStreet's blog came after the stock had nearly doubled in a week, but that's the Feuerstein forte - watch a stock run, then comment negatively.  There's little chance that Feuerstein or Cramer's TheStreet.com will help the small investor find stocks with potential before they run, they're there strictly for entertainment value and to help whatever 'friends' they may have in the business, in my opinion.
 
Other than that, links to all of my recent comments and opinions about Cel-Sci are provided above.
 
Thanks for the email.
 
Disclosure:  Long CVM.
 

Readers Respond: BIEL

A comment regarding BioElectronics Corp:

Vin, I gotta be honest, I am beginning to lose faith in Biel. This thing has just been going south for months on end. At what point do we cut our losses? I too had been buying more on these lows but jeez...



VFC's Take:   Aside from a couple of minor price spikes along the way, BIEL has continued to trade with no life since flying to twelve cents forever ago.

It's tough, and grating to watch one of your stocks sit in stagnant water for so long, and it's easy to lose faith, but each investor must stick to his or her own exit/entry strategy and rely on DD to decide whether or not to weather the storm. 

BioElectronics, for me, is an event or price based investment.  On the event side, I'm waiting for developments - international growth and distribution, introduction to new markets, sales growth and of course the FDA outcomes.  I don't feel like I'm giving the company, or myself, a fair shot if I bail out while the story is still developing. 

On the price side, I've got some price-based strategies as well.  For instance, since BIEL has traded so low for so long, I consider five cents to be the new ten cents, so I'll sell some at that point, unless news is signficant enough that the price will bash through five and not look back for a little while.  I'll also take advantage of the less significant spikes once in a while, as in a run to two cents, but - since I'm in for the long term - I don't always have the time nor the inclination to stay on top of the daily trading to take advantage of the less-than-double-runs.

Another battle that the small investor faces while deciding whether to hold through the storm or not is knowing that the big boys have a lot more on their plate than we do.  We'll have a handful of stocks that we watch and an even smaller handful that we'll buy because we're limited in time and resources.  Meanwhile, the big boys have twenty four hours/seven days a week and a whole lot of other people's money to watch and play the markets with, so they're eyeballing a new BIEL play at least every week.

Once a stock has enjoyed a nice run, there's got to be a period of consolidation; for some stocks that period is longer than for others. 

Additionally, outside events - such as the FDA and other sources for significant events - could throw a wrench in things.  I don't believe that BIEL would be trading for a penny right now had the FDA approved the company's 501k applications months ago, for instance, so the longer these events take to unfold, the longer the stock will hang in the doldrums until something gives. 

There are those that will tell you that they knew the FDA would not approve earlier this year - that BIEL was dead wrong all along in putting up a positive front - but unless those individuals are ready to front insider information, then their guess was just as good as yours, one based on their own DD and their own interpretations of that DD.

There's also the 'get bash crews', as I like to call them.  These guys spend countless hours, day and night in front of a computer, typing away and creating feelings of uncertainty, panic and fear around certain stocks.  Common sense tells us that no individual is willing to spend that amount of time away from friends and family sitting in front a computer monitor writing negative things about a stock in which they have no financial interest in.  Since BIEL still has a very determined 'get bash crew' out there in cyber space, I'm inclined to believe that there are still a few entities that are benefitting financially by keeping the price in check for the time being; whether that be because they want to keep loading up on the cheap, or whether they are still covering shorts - and don't let them tell you that shorting and naked shorting doesn't go on in the penny realm, because the big boys can do what they want.

The point here is to emphasize that there are many factors that play into the trading action of these speculative stocks.  In order to reap the rewards, sometimes you've got to wait, endure the dips and wait some more.  Only the most patient investors with high risk tolerance for risk can do this, and I don't recommend that the speculative biotech sector is for everyone. 

BioElectronics may turn out to be a dud in the end, but I'm not going to "cut my losses" until I see a development materialize that tells me that the company is done.  If the products don't catch on either at home or abroad, or if the company loads share after share on the market in an irrational manner, then I may bail out.

For now, this a company with solid products that is enjoying a period of revenue growth and waiting on news of OTC approval in the US.  The story is still developing, and I rarely bail out on developing stories unless I need to throw some cash elsewhere.  But that's just my style, and it's worked well for me; each investor must consider the risk/rewards for themselves.

If you sell, sell because it's part of your planned exit strategy, but impatience is not a reason to sell a stock.  In my opinion, that borders on greedy as it buys into America's mentality of everyone feeling like they have to - and are entitled to - get rich quick.

Let's let the story develop.

All just my own opinion, each investor must conduct his or her own DD and base investment decisions on that DD.

Disclosure:  Long BIEL.

Readers' Picks: KBLB

A comment regarding Kraig Biocraft Laboratories Inc:

Hi Vinny,


This is not related to BIEL, but i was wondering what is your take on KBLB, seems to me something huge is around the corner.

Appreciate



VFC's House:  KBLB has been a HUGE runner over the past couple of weeks, jetting from penny status to over twenty cents in short time.  The stock closed the week last week at just under twenty two cents. 

Congrats to those that were along for the ride, this stock has been a fine example how long term patience in a good idea can pay off, and it's also an example that one winning pick out of a handful of stocks is all you need to stay ahead of the game. 

With huge gains already realized, the only question remaining is whether the stock's run will continue or not. 

The company definitely has contrived a groundbreaking technology; by genetically engineering silkworms with DNA from a spider,  the silkworms are able to spin spider silk.  Spider silk is one of the strongest fibers out there and this 'discovery' has huge potential in the commercial and military markets. 

The developments from this company are still unfolding, and can largely be followed at BioMedReports,  but each investor must stick to his or her own investing style when deciding whether to get in now or wait and see what happens.

For instance, I'm not a fan of chasing stocks that have already enjoyed a huge run, and this one has definitely already enjoyed a huge run, but one must also respect the potential for additional news or developments that could continue to send this stock higher.  That would have to be news of a major partnership at this point, in my opinion, with KBLB already trading for a market cap of over 100 million.  That said, speculation could continue to drive this one higher over the short term as we're talking about a groundbreaking event here.

On the other hand, KBLB is a stock that was trading for a penny only weeks ago, and it's common for groups of riff-raff to come out of the woodworks and start bashing stocks into submission that have just enjoyed huge runs.  These players usually don't have the forsight or know-how to come up with good picks on their own, so it's my guess that they read the likes of VFC's Stock House and/or BioMedReports to find good picks, watch them rise (and maybe even enjoy the long ride up), and then jump on the short side after the run and act like it was a bad idea all along. 

It's possible that could be the case here, also.

Since there seems to be just as much chance that the run could continue as there is that it could be petering out about now, you've got to protect your investment both ways, if you're looking to get in now.  That would mean only buying a small portion and waiting to see how the next week plays out.  If the run continues, then you've got something in there to ride higher, but if the stock starts to retrace, then there's money on the sideline to average down.

There's a chance this one can go higher - I'd imagine that some big players would want to be in on this technology - so it's not out of the question to predict a continued run, but I do have to admit that I think that there's a little more of a chance of watching it slide at this point, barring any significant news updates.

I will add that if I were in from the penny range, I'd have taken most of money off the table by now and booked a few vacations, or bought wifey a new Prada bag.

Do keep in mind that the company has planned a joint press conference with the University of Notre Dame for this upcoming Wednesday, so if big news was pending, it could come later this week. 

Let's break it down:

The Good: 

- A huge technology with fantastic potential in both commercial and domestic applications.

- The possibility of a big partner coming on board.

- Thos possibility of government grants on the way.

- The stock, already a huge winner, is on a lot more radars right now.

The Bad: 

- Since the stock has enjoyed such a huge run, it could be primed to be played to the short side.

- The company is still in the early stages of bringing its technology to market, there's still a long way to go before full mobilization takes effect.

The Ugly: 

- There seems to be a group or two (at least) out there that waits for big winners to run before shorting the stock back down so that they can buy in themselves after missing the boat the first time around.

The Bottom Line:   Still has room to run, knowing the commercial and military applications of the spider silk, but there's just as much a risk that a retracement will take place.  I don't see a drop back to the penny range, but barring additional significant updates, I wouldn't be surprised to see a dime again.  I'd say tread carefully, buy in with a fraction of what you'd intend to buy in with and wait to see what happens.  If you've been in from the start, take profits!  That's a huge run. 

As always, each investor needs to base his or her investment decisions on experience, personal entry/exit strategies and individual DD.

Readers' Picks: AVNR

From Sanodurfer25 regarding Avanir Pharmaceuticals:

Hey Vfc,

Any thoughts on AVNR, FDA decision date 10-30. It is a solid company with some huge potential. Your thoughts would be great. Thanks



VFC's Take:  The October 30th date referred to in Sano's comment is an FDA approval decision regarding AVP-923, Avanir's treatment of pseudobulbar affect (PBA) for which the company has supplied the FDA with requested additional information. 

Shares of AVNR skyrocketed on positive Phase III results over a year ago, and many investors are speculating another run if the FDA decides to approve for the PBA indication. 

It's my opinion that Avanir has some good mid to long term potential, but it's the short term that raises some questions.  I expect that investors will see some volatility leading into the late October approval date, possibly a run leading up to that event, but I'm not convinced that a huge spike will occur after the decision is announced, even if it is a positive one.

The trend has been tricky in the biotech/small pharma realm of late, with some high profile approvals leading to declining share prices after the news is announced (see:  DDSS for one).  It looks like the old 'buy the rumor, sell the news' addage is in play.  One thing that may save Avanir from such an event is the fact that the company is ready to launch the product relatively quickly - early 2011 - if approved October 30th. However, even if the launch takes place relatively quickly, there will be some lag time before full commercialization is in effect and that gives time for the stock to dip for a few months in order to consolidate.

Since there were some safety questions regarding AVP-923, there's an additional level of risk than many other FDA approval trades.  I get the impression that if the market believes there's a higher level of risk with this one, it would make more sense to have a speculative run before the approval date, then a drop soon after, whether the drug is approved or not. 

As I've stated before regarding Labopharm and BioDelivery (among others), a stock is a much safer buy after an approval, and the big boys know that, so I wouldn't be surprised to see AVNR follow the same pattern as DDSS, per say, offering up a buying opportunity after the good news is released.  The big boys can play these small pharma stocks like clockwork, so it wouldn't surprise me at all to see them play the same games with this one in hopes of going long for a lower price.

I'm sitting this one on the sidelines right now, not willing to buy in for these prices before the announcement.   I may consider buying in if there is a post-approval dip (assuming the product is approved), or if the FDA asks for more time, which would also cause a drop in price, in my opinion.

If you're already sold on AVNR, I wouldn't suggest going all-in now.  I'd say wet your beak with a portion of the money that you intend to put in this one, this way you are in if the stock does run, but you're also leaving yourself room to add shares if the stock drops.

If it runs, you might kick yourself for not going all-in, but at the same time, I think it's a worse feeling going all-in and then watching the stock drop.  At that point you'll be wishing you had some money on the sidelines to add shares.  Each investor needs to consider each possibility and draw his or her own conclusions.  I personally believe that going all-in on the first buy is irresponsible trading, but to each his own.  By doing that now, you're betting on approval AND a post-approval spike.  Possible, but I always recommend protecting yourself against any eventuatlity.

Another reason that I won't buy in now is because I personally believe that AVNR is getting a lot of attention lately, and I like to buy into stocks before they're getting all that attention. 

Let's break it down:

The Good: 

- Possible approval on the 30th. 

- Decent amount of money in the bank to cover expenses for the near term.

The Bad: 

- Trend in sector has many stocks dipping after positive approval news.

- Lot of media attention on the stock right now, which could be an indicator that the big boys want you to buy now - and if they want you to buy now, that means that they may want to short the stock later on down the road.  The weak hands then sell their shares to those shorts at a lower price.

- FDA may ask for more time.

The Ugly: 

- Nothing here is ugly enough to scare me away, but I am a bit sceptical of how the price will react after the decision.

Bottom Line:  Don't go crazy at these prices - if the stock runs after positive news, congrats - enjoy.  If the price drops post-news, then decide at that point whether to add or not.

Good luck.

Dislcosure:  No position.

Brief: (BIEL) ActiPatch Direct Response TV Campaign Expands Throughout Canada

An update on the BioElectronics website announced on Thursday that a mjor Direct Response television campain is under way in Canada.  Two-minute ActiPatch commercials will air on four top channels for about a month.  This DRTV campaing expands on the launch into select Canadian markets back in April.

We've still heard no news regarding the 501k applications with the FDA, but BioElectronics is well positioned to take advantage of the international market while news on the homefront is slow to materialize. 

The last quarterly report for BioElectronics showed significant growth on the international sales front, and that trend should continue while the US FDA continues to put the BioElectronics products on the backburner here in the United States.

Shares of BIEL remain trading for just over a penny, a price that I believe is ripe for accumulation.  The products are effective, judging from user testimonials, and safe.  As the consumer looks for alternatives to the drugs with dangerous side effects that retailers love to shove into our systems, the ActiPatch and Allay could be left standing as that safe alternative.  Tylenol and Ibuprofen - the two main drugs for which BioElectronic's would replace - both have side effects that could affect the liver and kidney, according to recent studies.

We've seen no unsafe side effects from the ActiPatch.

Speculative stocks such as BIEL are born to test your patience; patience in both time and volatility.  It gets pretty boring watching a stock remain stagnant for long periods of time, but when these little guys move, they move quick. 

Some investors have also had trouble purchasing the BIEL stock on the major brockerages, but I've mentioned here before that there's been no such trouble at Zecco, where unlimited trades go through at $4.50/per.

Having already experienced a huge run last year, BioElectronics could be gearing up for round two, only this time there should be some significant sales numbers to support the run.

Disclosure:  Long BIEL.

Readers Respond: MHAN

Visit ProfitsRun.com

From Franco regarding Manhattan Pharmaceuticals:

Haven't heard about MHAN in awhile and was wondering if you still believe they could complete their trials as well as launch Hedrin in the US? MHAN hasn't provided any updates lately even after raising additional capital and it looks like investors are starting to bail because of the lack of information. Thanks for your insights.



VFC's Take:  It's true, there's been no news or updates from the company or from the joint venture with Nordic; the share price is dropping and it does look like some investors might be bailing out from frustration.

Effectively, it looks like MHAN is dead-in-the-water.

However, one bit of positive news on the Hedrin front could turn this stock around in an instant.  TTNP was another very dead-in-the-water until an after-hours press release announced the approval of Fanapt.  While Hedrin to the North America looks like a no-go right now, that could change quick if Nordic and Manhattan get their act together and come out with some news during the last few months of this year.

Investors were supposed to have heard news about a Hedrin trial and possible approval timeline by the summer of this year, but that expectation has passed and now we're in 'up in the air' territory until something gives.

There's a share dispute ongoing between Nordic and Manhattan and it's possible that this joint venture - and the MHAN stock - will be suck in the mud until that issue is resolved.

Because Hedrin could post some decent sales numbers in the US as a pesticide-free head lice treatment, I still think it's worth holding or adding shares of MHAN as a speculative 'night on the town' pick until we hear of a final plan or resolution for Hedrin in the US.

I also believe that with the way shares have been dished out during the joint venture, management has it in their own best interest to at least pump and dump this one at some point.

Disclosure:  Long MHAN.

Readers' Picks: SNSS

From Jam regarding Sunesis Pharmaceuticals, Inc.:

Another potential cancer biopharmaceutical stock is SNSS which has apromising Leukemia treatment(Vosaroxin) going into Phase 3 soon.Keep an eye on that one in 2011.



VFC's Take: Appreciate the comment, Jam, and I agree that Sunesis is another decent, speculative pick that will be worth keeping an eye on forthe remainder of this year and throughout 2011.

The stock enjoyed an impressive run in price to over two dollars late in 2009, although that was at a time when there were a lot less shares on the market. Currently, the company has about 222 million shares outstanding with amarket cap of just under 90 million.

The 90 million number does leave room for some speculative upside, in my opinion, and it's possible that a mini-run could be in store if the PhaseIII Vosaroxin trial commences as planned later this year. See the recent trading action of Cel-Sci for an example of what a nice 'Phase III commencement run' can look like.

The upcoming Phase 3 trial, known as VALOR, is planned to be a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in the treatment of 450 patients with first relapsed or primary refractory AML.

Recent financing deals have Sunesis sitting on a solid cash position, at least for the time being, but another stock sale later on down the road cannot be ruled out. I do believe that this stock will see a speculative jump before another round of financing will be needed, but that's just my own opinion.

Progression of the vosaroxin trial and possible developments from the remaining pipeline should have this stock on everyone's speculative radar moving into 2011.

Not quite the value that it was when SNSS last traded for this price (as a result of additional shares on the market) but still a nice longer term speculative play. 

Disclosure: No position.

CVM: Gotta Watch It

Cel-Sci has caught the spotlight once again over the past few trading days, first triggered by a huge spike in volume, only to be followed by a significant spike in price as well. 

Following up a day in which CVM traded as high as twenty percent to the upside on Tuesday, the stock closed Wednesday up nearly another twenty percent, on volume again nearly ten times the normal trading average.

At first investors can consider it a fluke, but now it's starting to look like a pattern.  That's not to say that the stock is going to move twenty percent a day for the foreseeable future, but it does look like something is once again brewing at Cel-Sci, because volume like this, especially with the price increse - does not just happen out of the blue; something's up.

There have been buyout rumors thrown around, as well as rumors of the Multikine Phase III trial gearing up quickly.  It's also been speculated that an article from the Motley Fool is solely responsible for the run, but the truth of whether the run is valid or not will lie in the next news release.

Multikine, if proven successful and ultimately approved by the FDA, is hands down a billion dollar masterpiece, so it will only take a little bit of speculation to launch this stock into a double or a triple, but we've got to keep in mind that there are still a lot of non-believers out there - and rightfully so, because you never want to hear only your side of the arguement.

Right now, however, the stock is sitting at about a double from only weeks ago.  It just goes to show you how long a stock can stay stagnant (accumulation time) and almost bore investors into selling, only to turn on a dime and pay quick dividends.

Who knows what's going on behind the scenes right now, but I'm liking the odds of some significant news brewing.  Mississippi was just a teaser, if you ask me, and Multikine should be about ready for the full Phase III. 

The pullback to forty cents was a gift after last year's run, and the returns are already starting to roll in - but it's still a long way off until we know the results of Multikine's just-started trial, so each investor should protect his or her investment by taking a little bit off the table once in a while; play the spikes and dips to protect your investment, but I like CVM as a nice long term hold. 

Multikine is alive again.

Disclosure:  Long CVM.

Brief: Titan Pharmaceuticals Announces Full Enrollment for Probuphine Phase III

Although Titan shares did not respond to the news, the company announced early on Wednesday that full enrollment in the confirmatory Phase III trial had been reached.  The ahead-of-schedule enrollment now has Titan expecting to announce results in the second quarter of 2011, three months earlier than previously estimated.

The Probuphine trials are partly funded by an NIH grant and the product has already proven to be successful in previous trials. 

Titan is also receiving quarterly royalty payments from Vanda Pharmaceuticals for sales of Fanapt.  Still in the relatively early stages of the commercial launch, revenue from Fanapt could grow significantly through 2011.

With Probuphine nearing the completion of the clinical stage - and with the potential of Titan's ProNeura drug delivery technology - TTNP continues to look like a great long term pick.

The valuation for Titan Pharmaceuticals - when looking forward, not backwards - puts this company as a great buy right now, in my opinion.  Maybe not as good a buy as it was for a couple of penny's, but this one could still turn out to be a huge winner; and I'm still convinced that we'll see a buyout before the company can reach its full potential as a standalone.

Disclosure:  Long TTNP.

Two More Cancer Immunotherapy Picks Enjoying a High Price & Volume Combo

Cel-Sci Corp. has enjoyed the spotlight on Tuesday with a twenty percent price spike supported by huge volume, but it's worth mentioning two other cancer immunotherapy stocks that are also spiking on above-average volume.

Oncothyreon (ONTY) also jumped roughly twenty percent on high volume during Tuesday's trading session, leading one to wonder whether there is some significant news developing that could effect the cancer immunotherapy treatment as a whole.

Oncothyreon is developing Stimuvax in a partnership with Merck KGaA for the treatment of lung cancer.  Trials were halted for a time due to a safety concern, but the trials resumed in quick time after the FDA determined that the isolated event that led to the trial halt was unrelated to Stimuvax.

The company also has the PI-3 Kinase Inhibitor being tested in multiple Phase II trials.

No news has been released to justify the price and volume spike, as is the case with CVM, which leads me to believe that news may be brewing for either this particular stock or for one of its sister companies in the sector.

Stay tuned. 


 
Another cancer immunotherapy stock that has also enjoyed a price and volume spike over the past couple of days is Antigenics (AGEN).  Again, no news has been released to justify the move to a dollar on high volume, but it's another example of a recent pattern that could be indicated significant news in the sector.
 
Antigenics is developing Oncophage for the treatment of multiple cancer indications.  The product was approved in Russia years ago for the treatment of kidney cancer, but nothing has materialized in that country in the form of sales or distribution since then. 
 
Oncophage for the treatment of kidney cancer was denied by the European medical regulators and was never brought to the US FDA for approval.
 
However, the Phase II glioma trials have been positive thus far, and the vaccine adjuvant, QS-21, is being utilized in a number of Phase III products.
 
Already partnered with GlaxoSmithKline, AGEN holds quite a bit of longer term potential on its own accord and may benefit from any sector-wide news that may be brewing - if, in fact, there is any brewing at all.
 
Eyebrows should be raised for the immediate future while a few of these cancer immunotherapy stocks are pumping up the volume.
 
Interesting development, keep an eye on it.
 
Disclosure:  Long AGEN, ONTY.
 

Stock Brief: CLDX Moves on News of Phase IIb Initiation

 
Shares of Celldex Thereapeutics punched through the four dollar mark, adding another layer of legitimacy to the stock's comeback after crashing on news that Pfizer kicked the company and its partnership agreement for CDX-110 to the curb a couple of weeks back.

A news release issued on Monday stated that the company had treated the first patient in a Phase IIb study of the Company’s CDX-011 for the treatment of breast cancer.  CDX-011 was granted a Fast Track
Designation by the FDA in May.

The initiation of this trial shows that Celldex hasn't missed a beat since the Pfizer divorce, and there's still some nice potential in the company and its treatments, but some investors will always have it in the back of their minds that Pfizer may have known something that we don't that led to the decision to drop the partnership for CDX-110. 

Celldex is still alive and kicking during the post-Pfizer era, and may be worth a look for those still willing to buy after the recent bounce.

Disclosure:  No Position.

CVM: Cel-Sci Volume Soars, Price to follow?

 
Cel-Sci shares were on the move Tuesday, jumping as much as twenty percent on volume that was ten times the daily average.  No news was released in conjunction with the price and volume spike, but the recent start of the Multikine Phase III trial has renewed investor interest, especially after watching shares of Dendreon soar past the forty dollar mark after the success of Provenge.

Multikine, like Provenge, is an immunotherapy treatment designed to stimulate the body's immune system to fight cancer, and I believe that these treatments - and others like them still in development - will be looked back upon in history as a huge step forward for the treatment of cancer.

Multikine is unique in its own right because it is being tested as a first line treatment for head and neck cancer.  Most immunotherapeutic cancer treatments are administered during the later stages of tumor progression after other treatments (chemo and radiation) have already been used.

Tuesday's trading action could be a result of renewed interest in the stock, but it's also likely that last week's news release of the commencement of the Phase III trial in Mississippi was just a teaser of sorts, with more significant developments to follow.  It's not safe to assume anything in the market, so the Phase III may be slow to ramp up, but speculation could be enough to drive CVM right back towards the one dollar mark, undoubtedly a welcome thought to those who have been loading up for fifty cents over the past few months.

Four million shares traded is a big deal for CVM these days, and combined with the twenty percent price spike, Cel-Sci is looking like a more significant move could be in store.  At the very least, it's a stock to watch for the short term, and still one to accumulate for the long term based on the potential of Multikine. 

I'll be holding for now, waiting to see how the action plays out for the rest of the week, but I'll definitely add more on any pullbacks.

Good to see Cel-Sci turning heads again; the most anticipated event for this company has been the start of the Phase III trial, and investors can finally feel confident that Multikine is moving forward as planned.

On another note, with a new 'super-bug' being mentioned in the news over the past few weeks, I wouldn't be surprised to see a LEAPS press release at some point in the near future.

Disclosure:  Long CVM.

CELH: Short Covering or More Pain in Store?

The immediate future of the Celsius Holdings stock looked suspect after last Friday's late day price dip, but Monday's action may have created more questions than it answered. 

This had been a stock that was suffering for weeks through a stage of pathetic trading volume, with a blip to the upside during the week leading into Friday's late day dump.  However, that dump could have been the result of an investor exiting their position or it could have been a head fake initiated by the puppet masters behind the puppets whose job it is to create a climate of fear, panic and uncertainty around the stock in cyberspace.

Now, with Monday's trading session already in the books, what are we to make of the huge trading volume realized by CELH?  I say huge because for days on end since the last quarterly report, Celsius was stuck in the mud - lucky to see 10,000 shares or so trade hands on any given day.  So a day with 75,000+ in volume should raise some eyebrows. 

It is possible that someone who wanted to start exiting their position at 3:30 PM on Friday continued to do so on Monday morning, after all Monday's trading sessions gave investors ample opportunity to turn a quick buck in less speculative plays, but it's also possible that the puppet masters are starting to cover some short shares now that the price has been knocked down to a satisfactory level for doing so. 

It is worth noting, however, that the short interest really isn't that significant, in my opinion, even with a slight uptick in the percentage of shares short over the last couple of months.

No matter how you look at it, CELH is ripe for manipulation to the upside or down until some buying interest materializes, and that interest may materialize quick if the stock continues to hover for just over a buck, especially if the recent sales growth can be matched in the next quarterly report.

The answers to these questions of price and volume should play out in front of our very eyes during the next few trading sessions, and the volatility should continue if the ever-so-persistent cyberspace message board junkies is any indication.  Someone still has a lot of money at stake - whether it be short, long or a changing of position - because a couple of people are spending a near unrealistic amount of time making sure their messages of fear, uncertainty and panic are heard over and over again.

Let there be no mistake - someone's got a lot riding on this one, hence the need for such a loyal group of puppets who have essentially set up a 24-hour watch in cyberspace to ensure that their message is the dominant one.  It's a good thing Netflix streams movies these days, otherwise life could get pretty dull, I'd imagine, unless you played multiple personalities with fake foreign accents to pass time.

It's up to each investor to decide whether or not the stock and the company is going anywhere, and VFC loves the risk/reward profile of Celsius Holdings more now than at any given time since the stock traded for a nickel pre-split.

It's Celsius 'Buy Big Time' again, in my opinion - and even moreso if we trickle down towards a buck - a possibility if the real buying interest does not materialize since the puppetmasters are holding the strings right now.

The Good: 

- Solid product in a growing genre of a booming industry.

- Significant sales and distribution growth under way.

- New calorie burning products on the horizon with established distribution channels in place.

The Bad: 

- Long term downtrend highlighted by lack of buying interest.

- A couple of shaky quarters opened the door for shorts to rule.

The Ugly:

- The amount of time and effort that a couple of cyber-junkies have dedicated to paint Celsius Holdings in a strictly negative light.

- Mario Lopez. 

VFC's Take:  Solid Buy.

Disclosure:  Long CELH.

GNBT: News of National Distribution Punches the Stock Through the Fifty Cent Barrier

After a weekend of speculative anticipation surrounding Generex Biotechnology Corporation, Monday morning welcomed an exciting new week for shareholders who have been anxiously following the recent developments of the company.

It's been largely assumed by many that big news regarding Oral-lyn would the catalyst to launch this stock up to near the one dollar mark - and that still could be the case - but for now Generex greeted the new trading week with news of a national sales agreement for the company's consumer product line, which includes the Glucose RapidSpray, Crave-NX Diet Aid Spray, BaBOOM Energy Spray, and the Glucose RapidSpray for Pets.  Each of these products utilizes the same delivery method as the Oral-lyn insulin spray; absorption through the inner lining of the cheek. 

The sales agreement was with Elias Shaker & Company, a national name that has long-standing relationships with distributors, wholesalers, retailers, grocery and drug chains and just about any other retail point that you can think of.

The potential of the consumer product line does pop up in the news once in a while, most recently when it was announced that a subsidiary of Merck KGaA would move RapidSpray into the Mexican market, but these products have largely been considered an afterthought as Oral-lyn stole the spotlight during the later stages of clinical development.  With this deal, however, Generex has just announced another pipeline of revenue potential that could grow at a rapid pace once ES&C has the products on shelves throughout the USA. 

It looks like, at least for a short term as volume soared through the thirteen million mark on Monday, that the Generex rebound may be in full effect.  It also looks like Generex could have a lifeline should any unexpected hiccups delay the progression of Oral-lyn.

Truth be told, however, the near to mid term success or failure of Generex lies with the fate of the Oral-lyn Phase III trial and (if positive) the ultimate approval decision by the FDA. 

The news of consumer product sales potential and distribution is highly encouraging, but it could just be a set-up for more significant news on the Oral-lyn front that may launch the share price straight towards a dollar where - if it were to remain for ten consecutive trading days - the need for a reverse split would be a moot point.

The short term future of this stock may not yet have revealed itself, but it's been my opinion for some time that we'd see a run to at least a buck before the Oral-lyn Phase III results were released.  The recent news announcements and price action are setting up for the perfect storm to allow that to happen, in my opinion. 

As always, there's no sure things in the stock market - no matter how promising a situation looks - and GNBT is no exception.  That said, the recent surge in price, volume and solid news releases gives investors a whole lot of reason to be excited about this company and stock right now.

I'll add on any pullback.

Disclosure:  Long GNBT.

GNBT: Developments Surrounding Generex are Quickly Getting Interesting

The trading week quickly turned exciting for long shareholders of Generex Biotechnology Corp last Friday, after news of an adjournment in a special shareholders meeting fueled speculation that good news regarding the ongoing Oral-lyn Phase III trial would render plans of a reverse split an afterthought. 

GNBT spiked 14% on Friday on trading volume nearly five times the daily average.

Aside from announcing a distribution agreement in Chile for Oral-lyn last week, Generex also announced presentations by the company's wholly-owned subsidiary, Antigen Express, regarding novel vaccine strategies earlier this month.  The presentations were made in Vienna, Austria and Cambridge, MA at the conference Gene based Vaccines: Optimizing Development and Delivery and at the Immunotherapeutics and Vaccine Summit, respectively.

News that has the speculative investing world swirling, however, has yet to publicy materialize.  It's been assumed by many that the talk of a reverse split by Generex management was pure posturing in an attempt to buy time until significant news hit the wires that could possibly launch GNBT on a run towards a dollar - where it would need to remain for ten consecutive trading days to avoid a possible delisting from the Nasdaq exchange.  The Nasdaq has not been in any hurry to delist the stock as of yet, recently confirming that fact by adding another month onto the timeline, but sooner or later either Generex or the exchange will have to budge in this ongoing game of cat and mouse. 

Last week's late trading action - which included that 14% spike - is a good indicator of just how touchy the GNBT stock could become when speculation about the possibility of news combines with the itchy trigger fingers of both traders and investors.  It's safe to say that any valid and solid news release to back up the recent speculation could send us on that march towards a dollar that many of us have been predicting and stave off the R/S talk that doesn't seem to want to go away - yet. 

A few times in the recent past - when GNBT experienced similar price bounces - I thought it was worth considering the fact that the bounce might be a pre-R/S game, but with the special meeting now nearly a month away, there could be something to this one; maybe the speculation is correct and Generex is sitting on some nice information that investors may become privvy to it this week.  That possibility alone should have GNBT at or near the top of everyone's radar come Monday morning.

However, management may still be intent on conducting this split and the additional time may be only to secure the needed votes to make sure that happens.  The little guy can only speculate on what's going on behind the scenes, and it's up to each investor draw his or her own conclusions.

Regardless, the potential of Oral-lyn and its delivery system is huge; it cannot be ignored, and is worth the risk/reward as a speculative investment, in my opinion.  If this product hits, then GNBT will become one of those investments that sets you up for years to come.

Keep in mind, however, that the first word of that last sentence is "if"; nothing's a sure thing in the stock market - it's always important to 'keep it real' by remembering that, no matter how promising a situation looks.

One way or another, it looks like exciting times are a-coming for Generex.

Disclosure:  Long GNBT.