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Tuesday, December 21, 2010

Briefs: AMRN, ONTY, CBAI

AMRN:  Shares of Amarin have been flying higher and higher this week after it was announced that patient randomization for its Phase III ANCHOR trial for the triglyceride-reducing AMR101 was completed, putting the expected results announcement on track for the second quarter of 2011 - ahead of schedule, according to earlier predictions. 

Positive results from another AMR101 Phase III trial, titled MARINE, were also announced earlier than expected and sent AMRN shares on an uptick last month.

AMR101 is slated to enter a billion dollar market - if approved - and a potential investment here lies not only with the product, but also with the potential that Amarin is a target for an acquisition or a partnership at the current time.

A true success story for 2010, AMRN is still worth keeping an eye on, although it's always worth partaking in some profit taking during runs like this one.

Disclosure:  No position.
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ONTY:  Oncothyreon, another 'cancer immunotherapy' company, announced on monday that it has initiated a Phase I/II trial for anti-cancer agent PX-866.  While PX-866 holds potential for the long term, the short term viability for Oncothyreon lies with Stimuvax, a Phase III cancer vaccine candidate currently being investigated in a Phase III trial.

ONTY has been a nice success story over the past couple of years after having spiked from sub-$1 levels, but huge returns would be in store if Stimuvax is deemed a success in Phase III trials and ultimately approved by the FDA. 

Keep an eye on Oncothyreon, everyone's been looking for the next Dendreon and ONTY has as good a chance at getting there as any.

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CBAI:  About this time last year Cord Blood America was rising on hype before the grand opening of its Las Vegas laboratory and facility that was to take place in late January.  That hype led to an early-2010 double in price before tapering off to the current trading levels.

Still a relevant company, if you're to believe that stem cell storage will be included in the wave of the future (I'm still on the fence about that one), Cord Blood America has used mergers and/or acquisitions as a way-ahead towards profitability.

One of those acquisitions was of Cyro-Cell Mexico, a similar company based in - you guessed it - Mexico.

However, a recent press released announced that Cyro-Cell International has filed a lawsuit against Cord Blood over the deal, arguing that Cryro-Cell is not an independant entity and therefore cannot consumate an acquisition agreement with Cord Blood.

Any developments relating to this suit are likely to be non-factors in terms of share price and potential.  The real potential of Cord Blood lies with the people, who will ultimately decide whether this service is worth the money in the long run.

As I stated before, I'm still on the fence on that one, but I do think that it's worth owning a few 'just in case' shares.  As always, however, any significant spikes should be used to flip a few 'trading shares', since this is still a hugely speculative sub-penny play.

Disclosure:  Long CBAI.

Posted earlier at VFC's NEW Stock House.
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BVTI: Making News Again

MOVED TO:  http://vfcsstockhouse.com/blog/article/-bvti-making-news-again

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EPCT: Ceplene Approved in Israel

Epicept continues to roll out encouraging news after a long period of dormancy. An early Tuesday press release announced that the company's flagship product, Ceplene, has been approved for marketing in Israel, with additional authorizations expected during the course of 2011 from other countries around the globe.

Ceplene is a treatment for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission and is already approved in Europe for that condition. As a result of discussions with the FDA regarding an approval in the US for Ceplene, Epicept will conduct an additional Phase III trial before moving forward.

Megapharm Ltd., Epicept's marketing partner for Ceplene in Israel, expects to launch the product during the first quarter of 2011.

EPCT is quietly becoming a story, once again.

Disclosure: Long EPCT.

Posted earlier at VFC's NEW Stock House.



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Monday, December 20, 2010

Readers Respond: NVDL

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An anonymous comment posted regarding NovaDel Pharma:

Vic, thoughts on an update for NVDL with Zolpimist being sent to suppliers in Dec for Jan launch per HITK earnings conf call? NItromist should also launch in Jan albeit smaller product/market. Somewhat validates commercialization of NVDL technology. Stock still low due to anticipated equity offering per sec filings, however, next product is spary viagra, Duromist. Market either via a license partner or even a PFE has to take notice that NVDL has finally (and I mean finally) been able to deliver. Plus per NVDL presentation on their site, they believe they can sign a deal that allows them to sell duromist via their own already domained website, duromist.com.

Assuming a 2% penetration rate on Zolpimist and a 15% royalty, zolpimist should be a $10mm rev stream for NVDL in 2011 pushing stock at least to a 50mm market cap or 50c with clinical & NDA on duromist (with hopefully an early license deal) adding more value to the stock in '11. And maybe they even pull a rabbit out of the hat with Velcera and even migraine product which is through phase 1.

Do you think this stock will ever be anything?

VFC's Take:  Just for clarification, I'm not Vic - sometimes VFC is confused as 'Vic'.

Regarding NovaDel, it's been just about a year since I last mentioned this company that is producing oral spray forms of common drugs.  As I mentioned in that last post, I'd grown sour on this company after it failed to do anything with its products once they were approved. 

That said, a year has gone by, the marketing deals are in place and NovaDel once again has a gleam of potential. 

The commercial launches of both NitroMist and ZolpiMist are pending and the company is taking steps to advance the remaining pipeline, according to recent reports, including the spray form of Viagra which should see a clinical trial in 2011.  Of course, there is also the imminent near-certainty of a dilutive cash raising event which is keeping the stock low for the time being, as the above poster mentioned.

I'm still not completely sold on this company because as relevant as I see the drug delivery technology to the marketplace, little has materialized over the years.  That said, it looks like things could be finally coming together for this small company and I'd support a speculative buy here. 

Personally, I wouldn't go crazy, but the right news and commercial developments could see NVDL return a nice double or triple in gains over the next 12-18 months.

Appreciate the comments, and I'll start watching this one a little more closely again.

Disclosure: No Position.

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Readers Respond: CTSO

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An email from Paul regarding Cytosorbents:

Hey,

I saw your blog post from October about Cytosorbents. Do you feel like the clinical trial completion will be announced soon? If you don't mind saying..How many shares do you own? What do you feel the stock price will be in a year? Thanks for your time and information!

Good Luck Trading,

Paul

VFC's Take:  Twice in October did I post about Cytosorbents, click HERE and HERE to be directed to those posts.

According to the most recent information provided by the company, the European trial for CytoSorb in the treatment of severe sepsis should be wrapped up during the first quarter of 2011, and recent estimates have it that the completion will be more towards the first part of the quarter than the latter.

If the trial is deemed a success and Cytosorbents is able to garner an approval and start marketing the treatment late next year, then it's possible - and likely, in my opinion - that the highs seen during the last significant run - in the forty cent range - will be surpassed. 

Since there is arguably no effective treatment for severe sepsis currently on the market, however, I think that CTSO could become a ten bagger in quick time once an approval is announced.  The potential here is huge, but let's not get too carried just yet - before we can count on significant monetary concerns, we need to see if the treatment works or not.

I generally don't disclose how many shares of a particular company I own.  I'm a small investor who tries to keep it real and I maintain my stock investing as a hobby.  I will trade some 'trading shares' into any spikes of companies I own, and likewise I'll add on dips if I still think the longer term potential is right.

2011 could turn into quite the solid year for CTSO investors should that European trial spit out some positive results.

Good luck.

Disclosure:  Long CTSO.

Weekly Stock Watch: ACTC, MNKD, CVM, MHAN

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ACTC:  After weeks of monumental volume that began when the FDA offered Advanced Cell Technology a history-making green lightto initiate only the second embryonic stem cell trial ever, shares of ACTC broke through the twenty cent barrier on Friday and set a new 52-week high of twenty one cents.

ACTC closed the day at just under twenty cents, nearly ten percent to the upside on volume triple the normal average.

It'll be interesting to see whether this most recent run is sustainable through the end of the year, as profit takers and traders may find the twenty cent mark too enticing an exit point to hold through the holidays. 

The long term potential of ACT looks better than it ever has, but after shooting up from a nickel in a short period of time, it's always a good idea - in my opinion - for an investor to reward his or herself with some of those profits, especially just before the holiday season kicks into high gear.

I still have my core position of ACTC intact, but with the trading shares about expended, I'll be looking to reload for the future on any potential pullback; it was only Wednesday of last week that the volatile ACTC revisited the thirteen cent range.

This one is still an excellent alternative to GERN as a long term stem cell pick, in my opinion, but no longer is Advanced Cell trading under the radar.  The recent news releases and impressive run have this company on everyone's radar.  I think there's still room for additional short term upside, but keep in mind that no matter how much potential this company holds for the future of the stem cell industry, the pipeline is still in the early stages of development.

Disclosure:  Long ACTC.

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MNKD:  Another week closer to the FDA's decision day for Mannkind's inhaled insulin spray, Afrezza, keeps MNKD on the front burner once again.  With the pending approval decision due, MNKD has traded as one of the more volatile stocks over the past few weeks, rising as high as $9.23 on December 15th after having opened the month three bucks below that mark.

Predictions regarding how the FDA will rule have been varied, with odds varying from 40% chance of approval to as high as 85% chance, depending on where you look.  Due to the fickle nature of the FDA and the fact that MNKD has already enjoyed a pretty significant run in short time, I'm always a fan of taking some profit off of the table before the decision is announced. 

Additionally, the nature of the biotech beast these days has seen 'approval' stocks decline in price after a decision is reached, regardless of whether that decision is positive or not.  There's no telling if MNKD will follow that pattern, so it may be worth holding onto some 'just in case' shares through D-day - if only because of the potential that Afrezza could revolutionize insulin treatments for diabetics - but putting a few bucks of profit back into the wallet is always a good thing right before the holidays, in my opinion.

Other items of note regarding the Afrezza decision:

- Generex's Oral-lyn, another insulin spray product - should be in the final phases of a Phase III trial and could be on the heels of Afrezza to market.  Oral-lyn has been deemed the safer alternative to Afrezza by some since the insulin is absorbed through the inner lining of the cheek, whereas Afrezza is an inhaled spray and the insulin is absorbed through the lungs. 

- A former Mannkind employee, John Arditi, filed a wrongful termination suit against the company alleging fraud and cover-up during Afrezza's latest clinical trial, although the lawsuit was voluntarily pulled a short time after it was filed.  There's no reason to believe that the suit will be a relevant factor during the FDA approval process, but the attention may lead to increased scrutiny - after all, FDA officials are only human.

Now less than two weeks away, the volatility should continue with MNKD trading and this is a big story - in terms of stock potential and diabetic treatment - to watch through the end of the year and into 2011. 

The days of diabetics receiving insulin through injections may be coming to an end.

Disclosure:  No position.
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CVM:  If the global Phase III Mulitkine trial is going to commence before year's end 2010, as indicated as late as last week in a press release issued by Cel-Sci, then time is winding down and a launch PR should be expected.

Investors have received updates on trial site approvals every step of the way, and a PR was even issued announcing a preparatory meeting in Prague where certainly some brain cells were killed, but probably as a result of activities not associated with Multikine treatment.

The trial is slated to be the largest ever conducted for head and neck cancer treatment, and since Multikine is being tested as a first line treatment, it'll be a pretty big deal when the launch date is announced.

There's no saying whether that will translate into a significant run in the CVM share price over the short term, but the long term potential of Multikine makes this one quite the intriguing pick.

There's additional potential wrapped up in the LEAPS platform, and the Baltimore area cold-fill facility offers a potential revenue stream from contracting services, but all eyes are on Multikine right now, and the end-of-2010 start deadline is quickly closing in on us.

Disclosure:  Long CVM.
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MHAN:  Manhattan Pharmaceuticals might not be so much as a stock to watch this week, but it's worth noting that there was a pulse in the MHAN ticker last week as the company announced preliminary Phase I/II results for AST-915, a treatment for essential tremor.
AST-915, a product developed by Manhattan's wholly-owned subsidiary Ariston Pharmaceuticals, was found to be safe and effective in the 18-subject trial, although the final data is still being compiled and will be released in 2011.

Manhattan is still a hugely speculative play, but one that could realize significant returns if the right news ever combines with any hype.  The most immediate potential for news revolves around Hedrin, an insecticide-free treatment for head lice for which Manhattan and joint venture partner Nordic own the North American marketing rights.

The two entities are locked up in a dispute over ownership of shares, however, and it's suspect whether the Phase III trial necessary for approval in the United States will ever take place.

MHAN should by no means be considered a safe long term investment, but the potential for a double or triple in price (if not much more) always exists with little known, small companies such as this one that have the potential to release relevant news.

Investments in these speculative plays should only be used with 'night on the town' money, as I like to say - meaning only money that was slotted aside for Grey Goose should be used.  This way, if it doesn't pan out, then all you really lost is a hangover, but if it does pay off, then that night on the town has turned into a few nights out.

I'm partial to some of these speculative plays, as it only takes one good hit (DNDN, TTNP, SIRI, CSUH, for example) to have you playing on house money forever.

Highly speculative, but worth watching.

Disclosure:  Long MHAN.
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Originally posted Sunday at VFC's NEW Stock House.

Readers Respond: BIEL



An email from MKTADDICT:

VFC,

Just a couple of questions for you, if you don't mind:

1. What do you think the odds are that BIEL will ultimately get FDA approval for it's portfolio of products; 50/50, 80/20 or some other guesstimate?

2. What level do you think that the stock reaches based on a positive outcome for approval by the FDA; 0.05 cents, 0.10 cents, some number higher than that?

I know that this is all speculation, but I am interested in your thoughts.

Thanks, in advance, for your time and consideration.

MKTADDICT

VFC's Take:  Hi, MKT, sorry it took a while to get back to this one, I've wanted to get VFC's NEW Stock House up and running before continuing on with 'Readers Respond'.  Since Google labeled this site as a 'spam blog' not too long ago, I decided I needed to have a running backup plan. 

There's been some concern from readers that the new site doesn't allow for comments, but if you follow the thread to the botttom of that day's posts there will be a 'comment' link there for readers to respond at the new site.  My email remains the same, vfcsstockhouse@hotmail.com or vfc@vfcsstockhouse.com.

On to MKT's questions:

1.  Ultimately, I believe that BioElectronics will receive FDA approval, it's the timeframe that I worry about.  I certainly thought that the FDA would have acted by now, but it seems that each year Washington outdoes itself from the year before in terms of futility. 

BioElectronics is a small company with products that would compete with those of the big boys, so the FDA probably isn't too concerned about taking care of business in quick fashion when it comes to the ActiPatch or Allay. 

Since ya just never know when it comes to the FDA, I'll give the odds of approval at 85/15, in favor of, but if the FDA sits on its hands much longer, international sales are going to need to rapidly pick up pace to keep BIEL on solid footing.

2. I think that we could see an initial spike to three to five cents at or near the time of an FDA approval decision.  Since the stock has traded for around a penny for so long, I think that investors would use that range to take some profits from the table, but the potential for higher prices would definitely exist over the longer term once the products were on the OTC markets. 

There's also the hype factor.  If a great deal of hype were to surround a positive FDA ruling, then who knows what can happen.  We saw what happened last time.

Of course this is only my opinion and speculation. 

Disclosure:  Long BIEL.

Thursday, December 16, 2010

EPCT: Stock Runs On New Trial Announcement

EPCT:  After announcing the start of a Phase II trial for anti-tumor agent Crolibulin by the National Cancer Institute (NCI) on Tuesday evening, shares of Epicept spiked pretty significantly during Wednesday's trading.  The close of just over eighty six cents, however, was still short of the recent highs achieved after the company announced a positive follow-on data review for Ceplene, Epicept's flagship product approved in Europe for the treatment of Acute Myeloid Leukemia (AML). 

Epicept has historically declined rapidly after sudden spikes, and this move shouldn't be expected to be any different, but the long term potential of the company remains, given the pipeline of Ceplene, NP-1 Crolibulin and Azixa.

Disclosure:  Long EPCT.

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CELH: An Update, Dead or Will it Bounce Back?

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It's been a couple of weeks since I last discussed Celsius Holdings, so I figured it's about time to see where we stand.  Volume and price have returned to a somewhat stable range after the large volume boost and swift decline in price that followed the disappointing results (to say the least) from the third quarter, at which time it became apparent that the company was not even aiming at the broad side of a barn with their 2010 fiscal estimates.

It's just about Hail Mary time for Celsius in terms of regaining even a shred of credibility after the failure to even approach the estimated numbers, and while the stock is trading for fifty cents - not a bad risk/reward level, in my opinion - I think that it'll be a little easier to attract speculative investors who see the possibilities of the product catching on in the health and fitness sector of the beverage market.

The company looked to be in just as dire straits when CSUH traded for 2.5 cents a couple of years ago and managed to pull out of that spin, so it might be worth banking on a turnaround like that again, although I wouldn't quite count on the three thousand percent gains being returned again if CELH does in fact pull it off.

Like I said, I see this as Hail Mary time, and even a bounce back quarter will do little to return credibility to the management team that missed the annual estimates by a margin big enough that you could move an aircraft carrier through it.

I still like the product and still like the possibilities of a bounce back, but there's reason to remain sceptical.  It's pretty convenient, if not suspicious, the timing of some of the events of the past 18 months, including an analyst upgrade (from Florida, conveniently enough) that played into a very significant price rise shortly before cyberspace was inundated by new group of Celsius 'get bash crew' guys that dedicated thousands of hours to creating fear, doubt and panic around the company and its stock.   

It's a whole new ballgame now for Celsius, no longer a potential breakout player in the beverage industry, but a company now just trying to hang on. 

Maybe things would be going a bit better if Pamela Anderson and Jenny McCarthy were marketing this thing and not Mario Lopez. 

Is it possible that Celsius can also be Saved by the Bell?

I know, I know, that was weak.

Disclosure:  Long CELH.

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MNKD: Volatility Rules the Day

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In a highly volatile day of trading on Wednesday, shares of Mannkind Corp hit a high of $9.23 and a low of $7.31 before closing the day at $8.20, down twenty six cents from the previous days close.  The move was accompanied by volume over double the daily norm.

The volatility is undoubtedly based on the upcoming FDA decision for Afrezza, an inhaled insulin product up for approval review, but profit taking should also be considered a large factor in the price swing as MNKD is up by over three bucks in a short period of time.

I always love the drama in the headlines after price action such as this, "Shares Plunge" and the such, but the truth is that a move like that could actually be considered relatively stable for the biotech sector before big news is due; but of course, it's drama in the headlines that sells.

I wouldn't be opposed to anyone picking up a few 'just in case' shares at this point, but I wouldn't go crazy here unless there is a significant dip in price before the decision.  With the way the sector has been trending lately, MNKD is likely to dip either immediately or shortly after a decision is announced, whether that decision is positive or negative, so a better entry point may materialize before it's all said and done with this one. 

Over the long run, there's still big gains to be had if Afrezza is approved.
Disclosure:  No Position.

Originally posted at VFC's NEW Stock House.

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GNBT: Another Patent For GNBT



Generex Biotechnology Corp. announced on Wednesday the granting of a patent by the Canadian Intellectual Property Office titled 'Aerosol Formulations for Buccal and Pulmonary Application'.

The patent relates to the drug delivery technology behind the could-be blockbuster Oral-lyn which delivers insulin to the patient through a spray to the inner lining of the cheek.

Oral-lyn is still being investigated for effectiveness in a Phase III trial, from which investors have received no recent updates.  Oral-lyn will be highlighted, however, in the January edition of a peer reviewed journal, although the results discussed in that report are relating to a European trial for the treatment of impaired glucose tolerance (IGT).

The additional patent gives Generex 162 relating to its proprietal drug delivery technology, with 101 still pending.

As I mentioned when the company reported the peer review study earlier in the week, this news is relevant and bodes well when assessing the future potential of the company, but for the time being it is just ancillary news as we await results of the Oral-lyn Phase III trial.  After all, the short term - and possibility long term - fate of the company relies on that trial being deemed a success.

The Generex stock generally traded sideways on the day on unimpressive volume.

Disclosure:  Long GNBT.

Originally posted at VFC's NEW Stock House.

Wednesday, December 15, 2010

ACTC: Mourning the Loss of a CEO

MOVED TO:  http://vfcsstockhouse.com/blog/article/-actc-mourning-the-loss-of-a-ceo

EPCT: Crolibulin Phase II Announced

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Epicept announced on Wednesday that a clinical Phase II trial was initiated by the National Cancer Institute (NCI) to measure the safety and effectiveness of Crolibulin, an anti-tumor agent, as a treatment for anaplastic thyroid cancer (ATC). The trial will test Crolibulin as a treatment in conjunction with cisplatin.

Crolibulin, if proven effective, could surpass Ceplene as having the most lucrative future potential for the company, although it is still quite a ways away.

Epicept has dropped off its recent highs in quick time, but this news may provide a temporary cushion to keep it from falling further. Additionally, Epicept announced that results from the latest NP-1 trial could be released in a few weeks time, and if positive, the long term potential of Epicept would become that much more confirmed.

A Phase III trial for Ceplene, already approved in the European Union, is also due to commence in 2011.

I like EPCT for the long term, but for the short term the stock has a tendency to retrace to previously traded levels after quick spikes and - as is always the case in the biotech sector - a cash raising event and/or dilution is always a possibility.

EPCT has been a better trade than investment over the years, but it's still worth maintaining a long term base, in my opinion.

Disclosure: Long EPCT.

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MNKD: On The Run

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Mannkind is ticking upwards as the FDA decision day of 29 December approaches. In about five weeks time the stock has jumped by about $3 off its recent lows, and it's possible that it could still move higher with two weeks left before D-day.

This run comes in spite of a lawsuit filed by a former Mannkind employee who alleged fraud and cover-up with the most recent Afrezza trial, although that employee subsequently pulled the suit.

The trend these days in the biotech sector is to watch an 'FDA approval' stock trend higher in the weeks before the expected announcement date, only to have it retrace after the news is released - whether the news is positive or not. That gives all investors the opportunity to bank some gains before the announcement - as I believe should be the case with this run, take some profits off the table when you can - but also gives investors the chance to 're-load' for the future during the post news drop.

The Afrezza decision is significant, as it would become the first approved inhaled insulin product for diabetics. It would also set the stage for Generex and Oral-lyn, another inhaled insulin product, although Oral-lyn insulin is absorbed through the inner lining of the cheek while Afrezza's is absorbed through the lungs.

Regardless, an Afrezza approval would validate the inhaled insulin platform, and that would be a good thing for Generex and Oral-lyn, although it would mean having some catching up to do when O-L hits the market (assuming it does).

Over the long run, MNKD still has a long way to move up with an Afrezza approval, but I'd be on the lookout for a post-news dip in price, since that's the current trend in the sector.

As always, I think it's worth taking some profit off the table during runs like this one, because you just never know - especially in the biotech sector.

Disclosure: No position MNKD, long GNBT.

Diamonds International

Tuesday, December 14, 2010

GERN: Class Action?

Posted earlier at VFC's NEW Stock House.

GERN:  Shortly after Geron announced the official closing of the most recent stock offering, reports surfaced that one or more lawfirms were opening investigations into the company with the intent of filing class action lawsuits.

The pretense for any suit would evolve from statements made by officials of Geron that indicated that the company was funded for the "near term."  As we have seen, the stock offering took place regardless of near term or long term funding.

I'm seldom a fan of class action lawsuits - especially ones initiated by lawfirms before there is actually a 'class'.  If there are two certainties that any small investor should keep in the war chest before throwing money at the market, it's that stock offerings and/or other forms of dilution are always going to be a part of the game and could occur at a moment's notice.

Even if there is money in the bank, these small companies - especially those with early to mid stage pipelines such as Geron - are going to jump at the chance to add more and solidify their future existence when the terms are acceptable (although it could be argued what "acceptable" is).

With that in mind, any knee-jerk class action investigation is based more on making some lawyers money, not handing cash back to the small investor - make no mistake about that.

You've got to have an iron stomach to invest in the speculative nature of the biotech sector, and if a stock offering and/or dilution has you screaming "lawyer!", then maybe this isn't the sector for you.

Additionally, it should be those entities out there that manipulate the markets and/or stock prices that should be held accountable to the small investor, if anyone, although manipulation is something else (along with dilution) that should be assumed is going to take place in the speculative sectors.

Jim Cramer (maybe the world's biggest big-headed hypocrite) is all over the Internet discussing the unethical tactics used by hedge funds - and others - to manipulate the markets, so maybe it's the likes of this guy and his cronies that need a class action filed against them.

You saw the repurcussions of these activities with the global market crash of a couple of years ago, but has anyone really been held accountable? 

Nope.

So it makes these class action rumors against Geron look even more futile; good money and exposure for the lawyers, though.

This may be a development worth watching, but more than likely it will fizzle away into the background.

Always assume that a speculative biotech play is going to have episodes of dilution and stock offerings, and always assume that the insiders are going to get better deals than you. 

That many not be the way it should be, but that's reality.

Disclosure:  No position.

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BIEL: A Stalled Rebound?

Posted earlier at VFC's NEW Stock House.


 
BIEL:  BioElectronics' quick reversal to back over a penny last week meant little during Monday's trading when neither volume nor volatility moved with any significance.  The current prices have given the traders a nice opportunity to flip a few of those .007 shares for a decent profit as the longs await news from the FDA.

It's a waiting game, at this point.  Announcements of new and cheaper products bode well for the future, but only FDA news or significant growth on the international front will move this stock in significant fashion over the short term, in my opinion, and both of those events may still be a bit away.

There's still some reports of investors not being able to purchase shares of the speculative BIEL with their brokers, and I'll again recommend Zecco for the low-priced trades for a high quantity of stock.

Keep an eye on BIEL, but I'm not sure we're going to get big news in the short term.

Disclosure:  Long BIEL.

AGEN: Buyback of Bonds

Posted earlier at VFC's NEW Stock House.

AGEN:  Antigenics has been flying under the radar of late with no significant updates or news to report, but the maker of Oncophage - a cancer vaccine currently being tested in Phase II trials for the treatment of recurrent glioma - announced the repurchase of bonds in an 8-k filing on Monday.

The event had no effect on trading, but could be a precursor to something else being worked behind the scenes.

Oncophage failed to show positive enough results in treating other indications to merit approval with the FDA, although it is approved in Russia for the treatment of kidney cancer.  Due to factors inherent with political environment in Russia, no sales have yet to materialize in regards to the Russian approval, however.

Antigenics also has QS-21, a vaccine adjuvant, being tested in multiple Phase III products and the company will receive a royalty of sales on those product, if approved.

Disclosure:  Long AGEN.
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GNBT: A Positive Peer Review For Generex

Posted earlier at VFC's NEW Stock House.

Generex announced a positive write-up of Oral-lyn, the company's Phase III insulin spray, in the scientific journal Diabetes, Obesity and Metabolism.

Included in the report, which will be published in the January 2011 issue of the journal, are data from a European study that demonstrated the effectiveness of Oral-lyn - as a buccal insulin spray - in treating patients with impaired glucose tolerance (IGT).

It is cited that not only does Oral-lyn positively effect the short term health of these patients, but it could also delay the onset of Type 2 diabetes, the general follow-on condition to IGT.

The exposure generated by a write-up in a peer-reviewed journal is definitely a positive for any company trying to embed itself on the biotech and pharmaceutical map, and for that reason, this report should be highly encouraging for shareholders of the GNBT stock.

Realistically, however, it means nothing in terms of the ongoing Phase III trial and a possible approval decision by the FDA, and likewise, the market did not respond at all to the announcement of this publication.

The appointment of high profile board members and the publication of European data for a peer-reviewed journal are nice ancillary notes, but investors need - and are anxiously awaiting - an update from the ongoing Phase III Oral-lyn trial.

A nice indication of success for the future treatment of IGT, but is this data from a 31-patient study going to influence the FDA in any way regarding approval?

No, so let's maintain an equilibrium of emotion. The write-up is a non-factor for the short term.

Disclosure: Long GNBT.

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Monday, December 13, 2010

Weekly Stock Watch: EPCT, SIRI, CVM, MNKD, GNBT

EPCT: Epicept closed last week on a high note, more than doubling for the week and trading nearly forty percent higher on Friday alone after the company reported positive new analysis for Ceplene.

Ceplene is already approved in the European Union (EU) for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML) and the company has adopted a plan with the US Food and Drug Administrations (FDA) to advance the product to market in the United States.

Follow-up data on an already completed study showed that some patients in the trial significantly benefited over those who did not receive Ceplene treatments in conjunction with IL-2, which is the standard treatment for AML in first remission.

That news led to EPCT's sudden surge last week.

It's been a long road for Epicept in bringing Ceplene to market in the EU, and the company still has to conduct another clinical trial to have a chance at market in the US. Accordingly, the stock has traded with significant volatility over the past few years, with large spikes often followed by long-time lulls in price.

I still believe that EPCT is a decent long term speculative pick, but Friday's news, while encouraging for the future prospects of Ceplene, did not offer any information that would have me to believe that the sharp runup in price will be sustained without the release of additional news.

Often times companies release longer term follow-up data on already concluded trials which induce spikes in the share price of the respective company - Biovest (BVTI) is a prime example - only to see the share price decline to previously traded levels in short time.

Epicept has a solid enough pipeline that additional news could follow - it's been a while since we saw an Azixa update - and the high-volumed surge could continue, but I thought Friday's quick spike was worth selling a few shares into, since the somewhat shady and/or misleading actions and words of management in the past don't have me whole-heartedly convinced that this news means anything.

Still, EPCT is a worthwhile pick to keep an eye on moving forward, and it'll be interesting to see what Monday's trading action brings.

However, unless last week's news is followed up with additional positive news, then i don't see the current price sustaining.

Disclosure: Long EPCT.

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SIRI:  Now that we know that Howard Stern intends to remain with SiriusXM, it'll be worth watching how the investor sentiment plays out on the SIRI share price.

The swift rise in price following the Stern news was a non-factor since that rise only negated a drop in price earlier in the week.

It's been my opinion that the Stern situation - regardless of how it played out - would have little impact on the long term prospects of the stock since SiriusXM has enough going for it right now in terms of new subscribers and much-improved content that Stern may even be considered dead weight with as much money as he'll be pulling in for himself; money that may be better used to pay down some debt.

Stern brings out the emotions in both his listeners and investors, so now that the situation is settled, it's possible that the stock will enjoy a bit of an emotional boost, but over the long term it doesn't really matter.

SIRI's rise from the ashes of a nickel price has more to do with the turnaround in the auto sector and the economy as a whole, but any Stern drama makes this one worth watching. 

That said, SIRI is a secret to no one, unless someone's been hiding in a cave for the past few years.

Disclosure:  Long SIRI.

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CVM:  I'm not sure there's been a company that has issued as many pre-trial press releases and Cel-Sci has over the past few months, but it's expected that sometime soon one of these announcements will be an announcement that a patient has enrolled in the program and received the first treatment.

The latest in the long line of teaser PRs came last week when Cel-Sci's manufacturing and laboratory operations were deemed compliant with the standards of the European Union, but the holy grail of Cel-Sci PRs has thus far still eluded us.

Once it is officially announced that the Phase III Multikine trial has commenced, it could bring renewed interest to the stock as the trial is supposed to be the largest ever for a head and neck cancer treatment. Should Multikine succeed in the trial as a first line treatment for those indications, then we could have a blockbuster on our hands. 

Watch the Cel-Sci wires closely, the recent rise could be a precursor to real news on the way, but it could also be another head fake. 

I'm still adding on the dips.

Disclosure:  Long CVM.

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MNKD:   With just two weeks left before the FDA is due to render a decision on Mannkind's inhaled insulin product, Afrezza, attention is sure to be attracted to the MNKD stock during the lead-up.  Debate has raged regarding the possibilities of an FDA approval and a lawsuit filed - but later pulled - by a former employee alleging fraud and cover-up regarding the Afrezza trials has only added to the drama.

The decision will be a significant one for diabetics who may receive an alternative method of insulin delivery to injections. 

Generex is also developing an insulin spray, Oral-lyn, although the Generex product delivers the insulin through the inner lining of the cheek while Afrezza uses the lungs.

A long-developing story may find some closure in just a few weeks, or it could just be getting started.

Disclosure:  Long MNKD.

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GNBT:  Generex announced last week the addition of Dr. James H. Anderson, Jr. to the company's scientific advisory board.  Dr. Anderson is the former senior medical director for Eli Lilly and will serve as an advisor on the regulatory process as Generex attempts to bring Oral-lyn to market.

Dr. Anderson is the latest in an impressive list of advisors that will be or are now serving on the company's board, but I wouldn't go so far as to say that the appointment of these officials in any way validates the company or Oral-lyn. 

It's a good move to stack the board with experience, but a stacked board means little unless the product is proven successful in trials.

Additionally, there's no doubt that these guys are being reimbursed handsomely for their 'advice', so their taking the job should not be mistaken for their belief in the product.  Bigwigs on their twilight tours like to pad their pockets just as much as the next guy, and these guys have already made a name for themselves in the industry - if Oral-lyn makes it and they're a part of it, then great; that's icing on the cake.  But their names and reputations will in no way be tarnished if Oral-lyn fails, so investors should not - in my opinion - take comfort in the fact that some high-priced talent is jumping on the bandwagon at a convenient time for the company.

Let's keep it real and take the news for what it's worth - and it's not worth much because we still haven't heard anything from Oral-lyn in a while.

Generex has a chance to benefit from any exposure generated by Mannkind and the FDA later this month, and that makes it a short term stock to watch.

Disclosure:  Long GNBT.


Friday, December 10, 2010

BIEL: Another New Product for BioElectronics, Investor Update



BioElectronics Corp announced the introduction of a new product on Thursday, another inexpensive and drug-free therapy for pain.

BIEL continues to develop lower-cost products in an attempt to attract curious customers who may not flinch at trying something new for a reasonable price, although none of these moves has yet to trump the long wait for an FDA resolution.

The product was presented at the annual conference of the American Association of Equine Practitioners in Baltimore this week, indicating that its intent is for veterinary use, but guess what - wink, wink - the product works on people, too. 

Is this an attempt to introduce the BIEL products to the American market before the FDA approves the company to do so? 

Meanwhile, on the actual FDA front, the company announced in an 'Investor Update' on its website that the FDA has requested additional information in regards to the new device classification.  Specifically, the FDA asked BioElectronics "to further define general controls for the new category and clarify previously presented clinical information."

According to the update, BioElectronics is devising a response now, but alas - we all know how long it takes the FDA to move, so it could still be a while before this situation is resolved.

The update did indicate a growth in orders and exposure in the European markets, so as has been the case for a while - it looks like international growth is what investors have to count on for the short term, unless people in the US start using 'pet patches' for their own ailments.

ActiPatch and Allay, on the other hand, are available on Amazon.

Disclosure:  Long BIEL.

BioDelivery Enrolls First Patient in BEMA Buprenorphine Trial

BioDelivery Sciences issued an early Thursday press release announcing the official launch of the Phase III trial for BEMA Buprenorphine in the treatment of chronic pain.

The company expects results from this trial to be completed by the third quarter of next year with an NDA planned for early 2012, according to the release.

BioDelivery already has ONSOLIS on the market for the treatment of breakthrough pain in cancer treatments, although the product has been slow to catch on due to REMS issues that are currently being sorted with the FDA in collaboration with BioDelivery's partner, Meda.

ONSOLIS is also approved in Canada and in the European Union.

BEMA Buprenorphine possibly holds even more market potential than ONSOLIS seeing as it would be entering a ten billion dollar market for pain. BEMA Bup may also be considered a safer alternative to other treatments on the market since it would be more difficult for patients to abuse it, when compared to existing products.

BioDelivery continues to be a nice longer term pick, in my opinion, with a pipeline of products based on the BEMA technology, which delivers drugs into the system through a patch on the inner lining of the cheek.

The possibilites are significant as the health care sector trends towards treatments that have less potential for abuse than existing ones.

Solid news for BioDelivery to close out 2010.

Disclosure: Long BDSI.

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SIRI: Stern Stays With Sirius

After weeks of posturing and months of speculation, Howard Stern has announced that he will remain with SiriusXM, the company that paid him half a billion dollars to flee terrestrial radio for the regulatory safety of satellite five years ago.

Terms of the deal were undisclosed, although it was announced by SiriusXM that they will now be able to stream Stern's broadcasts to mobile devices.

The private details of the agreement will leave many wondering if Stern actually did receive the pay cut that he so vehemently denied he deserved during recent broadcasts, but any decrease from a $500 million deal isn't going to garner any sympathy from the general public. 

As Major Payne once said, if you want sympathy, look in the dictionary between the words - well, can't expound on that quote here.

The SiriusXM share price closed higher by seven cents at $1.39, but the increase was deceiving since that closing price was still lower than the closing prices of earlier in the week.

In essence, the Stern news was received by the market as a non-factor, as it should've been received - a far cry from five years ago when the Stern signing launched the SIRI share price to nine dollars.

It made too much sense for Stern to remain with the satellite radio enterprise.  The pay-for-radio airwaves have allowed him the freedom to step outside the boundaries of free-radio regulation, even moreso for his over-the-top sidekicks and guests that enjoy pushing the limits on a daily basis.

A peak into the future financial reports will probably give investors an idea of what the actual terms of this deal were, but there's no doubt that it will probably still be considered too much.  With the economy and car sales on the rebound and new, quality content signed, SiriusXM has made itself a viable entertainment brand that would survive - if not thrive - with or without Stern. 

The self-proclaimed "King of All Media" can reign the pay-to-listen airwaves for another five years with the newly minted contract, or at least until listeners decide that it's a little creepy that a guy his age has twenty year old bikini clad honeys bouncing around his studio with sex toys.

Volume was big during Thursday's trading after the announcement, but an investment in SIRI is not one based on Stern remaining with the company - I'd consider it a nice touch to alleviate short term volatility, but it wasn't a necessary touch.

Disclosure:  Long SIRI. 

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Thursday, December 9, 2010

ACTC: Monumental Volume

MOVED TO:  http://vfcsstockhouse.com/blog/article/-actc-monumental-volume

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CVM: European Validation of Operations

After dropping to a low of eighty one cents during trading on Tuesday, shares of Cel-Sci rebounded to above ninety once again on news that the company's manufacturing and laboratory operations were found to be compliant with European export regulations. This validation clears the way for the export of Multikine in support of the imminent Phase III trial that will measure the vaccine's effectiveness as a first line treatment for head and neck cancer.

The validation of the operations is another necessary step to be completed before launching the trial in full force, and as the company continues to chip away at the official legs of the process, investors are anxiously anticipating an actual launch date.

The sheer potential of Mulitikine as a first line treatment for head and neck cancer still makes CVM an attractive pick if Multikine is your bet because we'll have another Dendreon Provenge story on our hands if this product is successful in Phase III trials.

As always, the speculative biotech market contains no sure bets, so taking profits when the opportunities present themselves is a must in the sector. Some have asked, "Why sell into a 'smaller' spike when the real money will be made when the good news plays out?"

Simply enough, there's not guarantee that the good news will play out - especially when it's a clinical trial being played. Additionally, any long position remaining will more than suffice if a biotech rockets, but you don't want to refrain from taking some profits just because you're anticipating bigger gains - that's getting greedy.

The risk with Cel-Sci still exists, as we don't know how the Multikine trial will play out, but if the product works - then Cel-Sci will become, like Dendreon, a multi-billion dollar company.

Definitely worth watching and definitely worth the risk/reward accumulation, in my opinion.

Disclosure: Long CVM.

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GERN: Full Options Exercised

Geron Corporation announced on Wednesday the exercise of the full over-allotment option of the company's recent stock offering, making the deal worth $100 million in total.

On the news, shares dipped below the $5 mark, significant only because the offering price was five dollars.

Geron has an impressive pipeline of Phase II and earlier products and is a recognized leader in the stem cell sector, having been awarded the first-ever go-ahead by the FDA to conduct a trial based on an ebryonic stem cell treatment.

As recently noted, Advanced Cell Technology became the recipient of the second-ever FDA approval to conduct such a trial.

Geron's market cap is still sitting at roughly half a billion dollars, a little spendy, in my opinion, based on a Phase II pipeline, but the cap is no doubt in respect to the potential of that pipeline and partnerships signed.

With Geron back to trading for under five bucks, it's definitely worth keeping an eye on as a possible long term accumulation pick. Any more significant drop closer to four bucks would make Geron a no-brainer, in my opinion and barring any bad news, although keep in mind that there's a long way to go before market.

I still believe that ACTC has more remaining upside for the short term than does GERN as a stem cell pick.

Disclosure: No position GERN, long ACTC.

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