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Saturday, April 30, 2011

CVM: Cel-Sci Phase III Ready To Go In Canada and India

The Multikine Phase III commencements and site approvals continued last week for Cel-Sci Corp., as the company issued consecutive press releases on Thursday and Friday announcing that all was set to go in India and Canada, respectively.

Patient enrollment in India, according to company CEO Geert Kersten, is expected to take place at a more rapid pace than in North America since head and neck cancer is the leading cancer in India.  Enrollment is expected to commence during the first half of May.

For a follow-up to the India news, Cel-Sci announced on Friday that the Canadian medical regulatory authorities authorized the commencement of the trial in that country as well.

While we have received no indication of how many - if any - patients have been enrolled in the trial to date, the company PRs state that the US site in Mississippi is actively recruiting, and the same will be said for the Indian portion of the trial as well in just a couple of weeks.

Multikine is being tested as a first-line treatment for head and neck cancer and the current trial is expected to be the largest ever for head and neck cancer, with over 800 patients expected to be enrolled from around the globe.

CVM shares have been stagnant for some time, as it's been a time for accumulation for those taking up positions based on the Multikine potential, but it's still well worth keeping an eye on this one if only for the sheer potential of Multikine if it works as advertised.

On the backburner is the LEAPS technology that seems to pop into the news with flu pandemics, but Cel-Sci is concentrating most of its resources towards Multikine right now.

With DNDN as the prime example of how significantly a cancer immunotherapy stock can move, CVM is as good a speculative play as any in the sector.

Keep an eye on it.

Disclosure:  Long CVM.


Yahoo! Small Business

Friday, April 29, 2011

Apricus Files For Vitaros Approval In Europe


This post is intended for VFC's Stock House only. No re-publishings or re-postings are authorized.

 APRI:  Apricus Biosciences announced on Thursday that it has filed a marketing application for the approval of Vitaros as a treatment for erectile dysfunction in Europe.

Vitaros is already approved in Canada for the same indication and an approval by the medical authorities of the European Union would allow Apricus to market the product in multiple EU countries.  The timeline for approval after filing in Europe is roughly eight months, making an approval decision before the end of this year a possibility.

Vitaros is already partnered in Italy and a request for approval in the US has also been submitted, although Apricus does not own US rights.

Apricus' financial position is solid, with enough cash on hand to carry the company well into 2012, and with quite a few products in the pipeline to go along with th potentially lucrative 'NexACT' technnology, Apricus could be an attractive buyout candidate.

Disclosure:  Long APRI.

Thursday, April 28, 2011

Readers Respond: Apricus - Why is VFC's Stock House Positive and The Fool Negative?

"Readers Respond" is a forum where VFC interacts with the readers of VFC's Stock House.  Readers can leave comments on posted material at either of the blog sites, through Seeking Alpha or via email, vfc@vfcsstockhouse.com.  All stock opinions, tips and questions are welcomed, whether agreeable with VFC's opinions or not.  Thanks for the comments, because without interaction - this wouldn't be fun.

optionsXpress

An email from Lordb to my Seeking Alpha inbox regarding my recent positive coverage of Apricus and The Motley Fool's negative coverage:
You have written positively about the outlook of Apricus Biosciences pipeline products and stock. And the stock started picking up. But, today Mortley Foos has written aboy Apricus totally negative about the future outlook and the pipeline products!

How the contradiction?


Lordb

VFC's Take:  Funny thing about opinions, everyone's got one - and there's nothing wrong with that.  You can't have an honest discussion or debate if everyone agrees.  Things are not any different in the stock market world than anywhere else.

That said, while there's nothing wrong with disagreeing over potential outlooks on companies, it looks pretty bad when you start name-calling because people disagree with you, as TheStreet.com's biotech blogger did recently when he called investors of Radient 'retards'

The Motley Fool is also negative on another company that I've followed for some time, Capstone Turbine.  In that instance, The Fool is concerned with the company's ability to finally turn profitable, while I have believed - and stated - that the time to buy is before profitability occurs, because if it does occur, then there's little chance the stock will be trading for around a buck, as it was earlier this year before more than doubling in price.

As for Apricus, it's still a speculative company, so it's a given that there will be varying outlooks for its prospects.

That said, I believe that The Fool's reasons for not liking Apricus are weak.  Granted, everyone should acknowledge that Apricus is not out of the woods yet - although the share price has been rising and the prospects for the future are shaping up nicely - but I'm not scared off by the competition for Vitaros.  The Fool admits that the market for erectile dysfunction is over two billion dollars per year, and Apricus only needs a fraction of that market to remain a viable company.  Or just have Berlusconi as a customer.

The rest of the Fool's argument is also speculative, and we don't know the results of how those situations will end up just yet - hence the speculation.

As always, each investor must devise an investment strategy based on their own DD and should not buyor  sell based solely on what is written on websites and blogs; use those place for ideas and discussion.

I tend to believe that APRI is still a solid speculative investment, that's my opinion. 

Don't be afraid of contradicting opinions.

Disclosure:  Long APRI.

Wednesday, April 27, 2011

Readers Respond: How Low Will CTSO Go

"Readers Respond" is a forum where VFC interacts with the readers of VFC's Stock House.  Readers can leave comments on posted material at either of the blog sites, through Seeking Alpha or via email, vfc@vfcsstockhouse.com.  All stock opinions, tips and questions are welcomed, whether agreeable with VFC's opinions or not.  Thanks for the comments, because without interaction - this wouldn't be fun.

optionsXpress

A comment posted to the VFC's Stock House Facebook page:

"I see that the market makers are having their way with CTSO, what would be a good entry price, in other words how low do you think "they" are going to push the PPS......THANX"

VFC's Take:  It's no secret that I believe that shares of Cytosorbents are being played right now, especially given the fact that the stock is consistently marked as one where sellers are not delivering the shares, a good indication of naked shorting.

That said, I have yet to take advantage of this most recent dip, but the twenty cent mark has been the price where I would consider loading up. 

Will the stock be beaten down below the current mark?

I think a lot of that depends on how quickly the company announced follow-up news, whether it be partnership or results of the secondary endpoints from the trial in Europe.

Any lull in news just gives the big dogs more time to play the stock.

That said, even if the secondary endpoints are only lukewarm, I still think we have a long term winner here because of the CE Mark approval, an event that came out of the blue since the trial was not yet completed and a good indication that the European regulators were overwhelmed with the evidence they saw for approval.

Short term volatility should not, in my opinion, have investors distracted from the long term potential of this company and its lead product - CytoSorb. 

Rather, I believe we're now entering load-up territory, which I consider to be the prices where the stock was trading before the CE Mark news.

All just my opinion, each investor must conduct his or her own DD and invest accordingly.

Disclosure:  Long CTSO.

Zecco Holdings

Readers Respond: ELTP

"Readers Respond" is a forum where VFC interacts with the readers of VFC's Stock House.  Readers can leave comments on posted material at either of the blog sites, through Seeking Alpha or via email, vfc@vfcsstockhouse.com.  All stock opinions, tips and questions are welcomed, whether agreeable with VFC's opinions or not.  Thanks for the comments, because without interaction - this wouldn't be fun.

optionsXpress

An email to my Seeking Alpha inbox: 

What's your thought on ELTP? ELTP has 3 FDA Approved Drugs including an approved diet drug like OREX. ELTP has huge volume recently, and it's only trading .09 a share right now. Just 72 Million Float. They have a 6 Billion Dollar Pipeline + 2 Oxycodone drug in phase 3. Company expect to launch 3 more fda approved drug this month. This is like a $10+ dollar stock trading at .09 cents right now. With 3 FDA approved drug and 20 more drugs in the pipeline, Do you think Elite Pharma a strong buy? Elite has back up support from Epic pharma as well.


Here is Elite Commercial pipeline
www.elitepharma.com/product_pipeline.asp


Listen to this webcast. Very good and strong possitive statements from company.
www.veracast.com/webcasts/bio/ceoinvesto...


Elite Epic Pharma
www.epic-pharma.com
the largest contract manufacturer in the United States for a large pharmaceutical company.

VFC's Take:  I've had Elite for well over a year now, since one reader emailed in about the company, but I've always considered it more of a trade play than a long term hold.  There have been various instances along the way that ELTP has jumped from below the ten cent mark to the mid-to-high teens, and in this most recent run - to over twenty cents.

The share price has more than doubled since this email came in, so in retrospect, of course it was a nice pick, but the question now is - will the run continue?

That's where I'm sceptical.

I was tempted to buy into ELTP after the drop that took place following a recent press release announcing that some of Elite's major revenue-generators were being pulled off the shelves by the FDA.  The company admits that its quarterly revenue would be hit hard by the facts.  Because ELTP is a known pump-and-dump play, I think that any dip in revenue will be reason to see the 'dump' end of the 'pump and dump', therefore I think it's hardly likely that we'll see a sustained run.

On the other hand, recent and pending launches offer an opportunity to make up for lost revenue. 

I will say, I don't trust this one enough to consider holding all the shares into a sustained run like this most recent one.  I'm a fan of using some trading shares to bank profits, and maybe hold a core group of shares for the 'just in case' future.

This is all my own opinion, of course, and each investor needs to make his or her own decision based on risk tolerance and investing strategy.

ELTP is one of the more risky plays out there, in my opinion, but has certainly offered great trading opportunities over the past couple of years. 

Bear in mind the risk, however, while enjoying the rewards.

Disclosure:  No position.

Readers Respond: SPPI Price Targets

"Readers Respond" is a forum where VFC interacts with the readers of VFC's Stock House.  Readers can leave comments on posted material at either of the blog sites, through Seeking Alpha or via email, vfc@vfcsstockhouse.com.  All stock opinions, tips and questions are welcomed, whether agreeable with VFC's opinions or not.  Thanks for the comments, because without interaction - this wouldn't be fun.

optionsXpress

An email from Trimmer to my Seeking Alpha inbox:
HI , Just wondering if you had upside and downside price targets on sppi.

VFC's Take:  Spectrum has a major milestone scheduled for this week, with the FDA due on April 29th to rule on Fusilev approval for the colorectal cancer indication.

On top of that, the company announced on Wednesday record revenue for the most recently completed quarter, which gives SPPI a compounded reason to be on the radars of biotech investors on the lookout for another JAZZ.

Along with the probability for market moving news, however, comes the risk of volatility.  Which way that volatility trends will have to do with how good - or bad - the news is.

There's no doubt that there is a positive trend with revenue growth, based on Wednesday's earnings announcement, but another setback in the colorectal indication would lead to a sharp - although temporary - decline in price, in my opinion.  That would offer an opportunity for the shorts and traders to put some downward pressure on the stock at an opportune time when bad news hits.

I wouldn't think that such a drop would be prolonged, due to the growing revenue from Fusilev without the colorectal indication and the fact that another market-moving event - the possible removal of the bioscan requirement that is now associated with Zevalin treatment - is due later this year.

It might be worth buying into such a dip, with eyes towards the mid to long term.

On the other hand, a positive decision later this week from the FDA would - in my opinion - send shares of SPPI on the way towards becoming another AMRN or JAZZ, or possibly both.

The biotech sector is quite the fickle sector, so it's tough to gauge short term price movements, but the long term trend of SPPI looks set to tick towards the upside.

Disclosure:  No position.



Capstone Turbine: Gearing Up For The Quarterly Report

It's been some quarter for Capstone Turbine (CPST), with the company stock reaching highs of over two dollars after opening the new year trading for under a buck. The share price increase was even accompanied by some good news and a Presidential mention mixed in as well.

The positive developments materialized on a very positive earnings report from the third fiscal quarter of 2011 that saw a 51% revenue increase over the same quarter of the previous reporting year.

Units shipped were up significantly as well, and "Capstone's backlog at the end of the third quarter was $84.7 million, up 8% from the same period last year," according to company statements in the third quarter earnings press release.

With results from the fourth fiscal quarter now expected and upon us, investors will be looking for additional evidence that Capstone is a company inching towards the long-time-coming goal of profitability.

The increasing backlog has been a comforting sign that profitability is drawing closer, but the revenue numbers will....

CLICK HERE FOR FULL ARTICLE

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Tuesday, April 26, 2011

SiriusXM: A Trader's Play or a Long Term Hold?

With earnings now known to be just a week away, it's time to put SiriusXM (SIRI) in the spotlight again.

Shares of SIRI have set a new 52 week high this week in anticipation of first quarter earnings, touching the $1.96 mark on Monday, which puts the stock well on its way to previous price projections of two dollars. With revenue and subscriptions on a sharp rise during the fourth quarter of 2010, SiriusXM not only marked itself as a company on the solid decline, but also as a pretty good long term pick once again.

With that in mind, SIRI is still just as much a trader's play as it is a long term investor's play.

The recent pattern for this stock has been to see pre-earnings runups followed by quick, although somewhat modest, declines after the numbers are released.

Following the fourth quarter announcement in February, shares fell to $1.68 for a short time before recovering to the current levels. This action, as it becomes predictable, makes SIRI a winner for all.

CLICK HERE FOR FULL ARTICLE

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ONTY: Oncothyreon Rising

This post is intended for VFC's Stock House only.  No re-publishings or re-postings are authorized.

Shares of Oncothyreon have been on the rise over the past month after a relative lull in news since the Phase III Stimuvax trials were restarted last year following a halt for what turned out to be unfounded safety concerns.

Stimuvax is a cancer immunotherapy treatment, like Dendreon's Provenge, that is currently being developed with commercial partner Merck KGaA for the treatment of non-small cell lung cancer.  While ONTY also has multiple PI-3 Kinase Inhibitors in Phase II trials, the Phase III Stimuvax is the closest product to market and provides the best short term potential to bear market-moving news.

The monumental rise of Dendreon following the approval of Provenge for the treatment of prostate cancer last year makes all investments in the cancer vaccine sector an appetizing pick, and Stimuvax is one of the later-staged candidates of those being developed.

The latest run could be related to the pending release of Stimuvax results, whether interim or additional long term follow-up, as there are some high profile cancer treatment conferences upcoming; but it's worth keeping this one on the radar, regardless.

Keep in mind that many cancer vaccines have tried and failed, but let Dendreon's stock be a testament to the gains that can be had if one does succeed.

Disclosure:  Long ONTY.

Monday, April 25, 2011

Cytosorbents Being Held Down?

CTSO:  While shares of Cytosorbents have been trapped in the mid-twenty-cents range since announcing the milestone approval of CytoSorb in Europe, recent reports have shown that sellers are failing to deliver shares of CTSO.

What's that mean? 

It means that someone, in my opinion, wants to add downward pressure to the stock and it's pretty evident that there might be some shorting and naked shorting going on behind the scenes to do so.

Since the approval news came out of left field, it caught many by surprise.  As I've mentioned a couple of times before, it should be expected that those that missed out on loading the boat for around six cents, or even the mid teens, will want the share price lower in order to pick up some cheaper shares.   

We've already seen the anonymous negative blogging go to work, and now we know that some sellers are not delivering on their end of the buy-sell deal.

The announcement of the secondary enpoints should come soon, and - if positive - that could provide another catalyst for this stock, but even if the results are not as stellar as some predict, the fact is this - CytoSorb is already approved in Europe.

CTSO is only that much more of an attractive buy when it's being pushed lower, and an eventual appreciation in price is almost a given as time moves closer towards a commercial launch of the product.

It's worth taking note that it's highly unlikely that the European medical authorities would have approved CytoSorb in Europe without full trial results unless they were overwhelming convinced that the product works.

Regardless of the short term movement, CTSO is still a 'buy the dips' play, because the long term is still looking bright.

Knowing that there might be shorting and naked shorting going on with this play, makes it that much more of a stock to watch this week and over the near term.

Disclosure:  Long CTSO.

Zecco Holdings

APRI: Trading Higher on Pending Catalysts



This post is intended for VFC's Stock House only.  No re-publishings or re-postings are authorized.

APRI:  Apricus Biosciences last week announced that the company had filed with the U.S. FDA to receive an orphan drug designation for RayVa, Apricus' experimental new treatment for Raynaud's phenomenon, a condition in which the blood supply to the fingers or toes is suddenly reduced.

Shares were trading higher after the news was announced, but APRI will be worth watching for the short term as it moves above the five dollar mark once again.

Additional partnerships for the erectile dysfunction treatment Vitaros are expected to be announced during the current quarter, and a payment in the amount of one million dollars from Italian partner Bracco, is also expected to roll in before the end of the second quarter. 

Apricus has a solid cash position, some attractive pending catalysts and a pipeline robust enough to keep it on both the short and long term radars of biotech investors.

Additionally, the NexACT drug delivery technology offers even more long term potential and could make the company as a whole an attractive buyout target for big pharma, as the big boys look to boost their pipelines.

Disclosure:  Long APRI.

EZTrader.com

TTNP: Titan's Close Last Week Makes it a Stock To Watch


TTNP:  Titan Pharmaceuticals was rising last week, on heavy volume as well, which pinpoints it as a stock to watch for the coming trading week. 

Volume initially picked up after the Novartis earnings report uncovered an 80% quarter-over-quarter increase in Fanapt sales, of which Titan receives an 8% royalty, but the pending Probuphine Phase III data that is due to be released this quarter also adds short term intrigue to this company.

Titan, which traded for just around a penny a couple of years ago before the surprising FDA approval of Fanapt, had traded as high as $2.50 since the approval and it's possible that shares could test those highs again during the lead-up to the Probuphine results.

I'm also convinced that Titan will ultimately end up becoming the target of a buyout, and it might be that potential acquirers are waiting on the final Probuphine study results before placing a value on the company.

Keep an eye on Titan this week.

Disclosure:  Long TTNP.

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Watch SPPI This Week, With Pending FDA Approval Date

SPPI:  Shares of Spectrum Pharmaceuticals traded higher to close the week last week after announcing that the FDA had approved a "ready-to-use" formulation of Fusilev, its FDA approved drug to treat Osteosarcoma.

The move upwards by SPPI may also be related to the FDA's pending decision for Fusilev in the treatment of colorectal cancer, which is scheduled to take place April 29th.  Fusilev for the colorectal indication has been denied once before by the FDA, but after supplying the regulatory agency with additional data, Spectrum hopes to see a reversal from the FDA's previous decision.

It'll be worth keeping SPPI on the watch list this week, as investors may jockey for positions regarding the upcoming approval date.

Disclosure:  No position.

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Sunday, April 24, 2011

Spectrum Pharmaceuticals: Upcoming Approvals Could Send Stock Flying

Already an attractive pick because of growing revenue and upcoming catalysts, Spectrum Pharmaceuticals (SPPI) announced last week that the FDA has granted approval of a "ready-to-use" formulation of Fusilev, which is already approved by the FDA in its lyophilized form to treat Osteosarcoma.

The new "ready-to-use" formulation "requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation," according to Spectrum CEO Dr. Rajesh C. Shrotriya in comments published in a press release issued on Thursday, and tt the very least will offer Doctors and medical professionals another option for utilizing Fusilev.

The share price and volume of SPPI reacted positively to the news on Thursday, as the stock closed higher by over two percent on more than double the average volume.

The real short term catalyst for Fusilev, however, is...

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eToro

Gilead's Earnings Miss a Hint to a Year of M&A?

Just a couple of weeks after Gilead Sciences (GILD) announced that it would be raising the prices of its leading HIV drugs, the company issued first quarter earnings numbers that were significantly below analyst expectations. The two events are most likely largely unrelated, however, as Gilead has in the past been known to raise the prices of some of its leading drugs, after they've been on the market for a while.

That said, since the earnings came out as an analyst miss just a short time after the price increase was announced, it might be safe to assume that Gilead is looking to make up some ground on lost revenue. During the first quarter, the lost revenue is being largely attributed to the sharp global decline in sales of Tamiflu, from which Gilead receives a royalty.

Generally, the threat of a worldwide flu pandemic would be viewed as an entirely negative event, but sometimes humanity and money conflict, as investors of Gilead now know. Since this flu season brought the threat of a pandemic, governments had no reason to buy Tamiflu in bulk, and Gilead's share price suffered in turn with a 4% drop after the first quarter earnings were announced.

That said, the signs were not entirely negative for Gilead during the most recent earnings period. Product sales, although down from...

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AVNR: Thursday's Action Has it on the Watch List

This post is intended for VFC's Stock House only.  No re-publishings or re-postings are authorized.

Avanir Pharmaceuticals (AVNR) will be on the radars of biotech and pharmaceutical investors next week as shares closed higher on Thursday by ten percent on volume over four times the daily norm.

The company was granted FDA approval late last year for Nuedexta, a treatment forpseudobulbar affect (PBA), and the product is set for a commercial launch this year.

Aside from this recent approval, Avanir has additional pipeline potential to bank on as Nuedexta chips away at the market and approaches the peak annual sales of between $350 and $500 million that has been predicted by analysts.

No news accompanied AVNR's rapid price rise on Thursday, which will only fuel speculation as to what might be pending, but this stock has been primed for a rebound since retreating after announcing a financing deal earlier in the year.

Avanir could also be on the radars of larger pharmaceutical companies who might be looking to immediately boost revenues and add depth to their pipelines.

Regardless of what caused Thursday's spike, this stock should be on the radars when trading resumes next week as a result of the price and volume surge.

Disclosure:  Long AVNR.


Thursday, April 21, 2011

TTNP: Titan Rising on Heavy Volume

This post is intended for VFC's Stock House only.  No re-publishings or re-postings are authorized.

Titan Pharmaceuticals should have drawn the interest of biotech investors on Wednesday with a modest price increase on fairly significant volume, and Thursday's trading added even more of the same as TTNP easily surpassed Wednesday's price and volume bumps.

It may have been the Novartis earnings report earlier in the week that showed a positive growth trend in Fanapt sales sparked this run, but it's also expected that Probuphine Phase III results will be released at some point during the current quarter.

Probuphine is a treatment for opioid additiction utilizing Titan's proprietary ProNeura drug delivery technology and fits well into the current trend in health care where a clamp-down in the abuse of prescription drugs is in effect.

The potential of Probuphine doesn't just stop with opioid addiction, however, as trials are also underway to measure its effectiveness in treating chronic pain.  The potential for ProNeura is also robust, as the technology could be used to deliver other approved drugs. 

These facts add significant value to Titan over the long term, and might have it on the radars of big pharma as an acquisition target.

Thursday's volume is indicative that it's on someone's radar, and this run has the potential to breach the two dollar mark, in my opinion, seeing as how news should be close.

Continue to keep an eye on this one.

Disclosure:  Long TTNP.



Fanapt Sales Growth Highlights Vanda, Titan Pharmaceuticals as Acquisition Candidates

It's always a significant event for both Vanda (VNDA) and Titan Pharmaceuticals (TTNP.OB) when Novartis (NVS) announces its quarterly earnings, since Novartis is the big-pharma commercial partner who is marketing Vanda's schizophrenia drug, Fanapt. Titan, through a long-existing licensing agreement for Fanapt, also receives an 8% cut of sales.

Novartis released its first quarter earnings numbers this week, and in the report it was revealed that Fanapt sales totalled nine million dollars for the opening quarter of 2011.

Although down significantly from the twenty one million number of Q1 2010, nine million dollars in sales is eighty percent higher than the fourth quarter of 2010; that's quite a noteworthy demonstration of growth on a quarter-over-quarter basis.

Fanapt's commercial launch also...

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Wednesday, April 20, 2011

Volume Alert: TTNP Up on Fanapt Royalty?

Shares of Titan Pharmaceuticals traded on nearly triple the average volume on Wednesday while moving higher by over five percent during late day trading.

One cause for the increased interest could be the Novartis earnings report from earlier this week that showed a sharp increase in Fanapt sales.

Titan receives an 8% royalty on Fanapt sales, and the quarter one number was nine million dollars.  That would make Titan's cut just over $700,000.

These volume/price moves are not uncommon for TTNP, and are often followed by sharp moves, whether it be to the upside or downside.  Since the stock has been trading at the lower end of the range set up this year, it's possible that the boost in volume could be tipping off another move up. 

Probuphine results are also just around the corner, so Titan should be all over the biotech watch lists right now, in my opinion. 

Keep in mind this stock's history of quick retreats after price surges, but then again - the company has never been on as solid footing as it is right now, at least in terms of pipeline developments.

Stay glued to Titan, this one might be getting warmed up.

Disclosure:  Long TTNP.

ACTC: Taking the Technology to Europe

MOVED TO:  http://vfcsstockhouse.com/blog/article/-actc-taking-the-technology-to-europe

CELH: A Spike in the Flatline, Preliminary Q1 Numbers Offer a Glimpse of Life

After announcing fourth quarter numbers at about the last possible minute, Celsius Holdings provided a glimpse into the first quarter numbers this week, and those numbers indicate that a turnaround from the monumental downtrend in sales growth may be in effect.

The $2.2 million in preliminary sales showes a marked increase over the Q4 numbers, but it's still below the take for same quarter of the previous year.

The difference is, however, that the company has stripped all the marketing and ancillary costs and lost only $500,000 - I say "only" because the loss was nearly six million in Q1 of 2010.

If there is a positive of the last few quarters for Celsius Holdings, it's that by now - after the mass marketing campaign - management knows where the product is sticking and where it isn't; that's something to build on.

That said, the company needs money.

That brings up the next item of the Q1 announcement, that "Catalyst Financial  LLC, a full service investment banking firm, to advise the company on strategic alternatives, including a potential sale of the company."

That statement would have me believe - because the "potential sale of the company" was highlighted - that selling the company is priority one right now, because there have been other players involved before to advise on "strategic alternatives." 

Of course, this is all only my speculation and opinion and the story will have to play itself out.

We all know that 2010 was ultimately a wash for Celsius, but 2011 is a whole new year - and it looks like the year is starting off on an up-note.

Stay tuned.

Disclosure:  Long CELH.

BIEL's Plunge on Form 15 Filing, What Now?

It was news of BioElectronics' Quarter Four 2010 results that investors were waiting on, but instead Tuesday brought an announcement from BIEL of a 'Form 15' filing with the SEC, a move that will keep the company having to meet filing rquirements with the regulatory commission.

According to the press release issued to announce the filing,

"The Board did not take this decision lightly. However, after consultation with our attorneys and auditors it became clear that the expense and resources necessary to meet the SEC's reporting requirements were too much for a firm this small," said Rick Staelin, Chairman of the BioElectronics Board. "We have decided to instead focus our limited resources on meeting FDA requirements and new marketing and sales efforts."

The big take-away from these comments, in my opinion, is that the financially-strapped BioElectronics has yet to recognize sales to a level significant enough to have the company standing in a legitimate growth phase.

As a result of the filing, again according to the PR, the Company will cease filing periodic reports with the SEC.



Now the question is - was the only intent of filing the form 15 to keep from having to file on a regular basis with the SEC?

For some time now BioElectronics has tried to cut costs by posting news and updates on its website, so not to have to pay the costs associated with issuing a PR, and now BIEL can save even more by not filing with the SEC.

If that was the goal of this move, then fair enough.

On the other hand, companies can also use this tactic as staging for an even more significant move - such as delisting the common stock or taking the company private.  The latter is especially a possibility, in my opinion, as it has been speculated before that the goal of the BIEL management was to go private.

Just something to keep in the back of the mind, because history shows that you've got to take what BIEL management says with a grain of salt. 

News of the filing on Tuesday sent shares spiraling to as low as just over .001 - and unfortunately I missed the most significant portion of that dip - before recovering all the way back to .0059.  Anyone sitting on their computer with a little cash on the sidelines during the drop and recovery of the BIEL share price yesterday afternoon would have been able to bank a couple of bucks in a real short time.

That said, the path of BioElectronics has been previously stated by management to be the finalization of audited financials and a move to the OTCBB.  We now know that the company is moving in the opposite direction to that goal (or at least those goals have been pushed back).

Because of this new development, the sudden price drop and recovery is best to be looked at as a quick trade, in my opinion, in order to at least bank something over the short term from a BIEL investment while we see what the true path of the company now holds.

Those holding HWEG shares earlier this year have seen how quick a company can pull the plug on the common stock when they want to.  I'm not convinced that BIEL intends to make a similar move, but it's only wise to entertain the possibility, in my opinion, since money looks low and a company will always save what it can of itself before it saves the shareholders.

Looking at the other side, this move doesn't spell ultimate gloom and doom either.  FDA news would still be hugely significant and relevant, and that news can still hit at any time, whether the company is hanging by a thread or not. 

Cytosorbents is a fine example of just how out-of-the-blue regulatory news can come.

At this point, it's best to entertain both sides of the story BIEL - it's still a high risk, high reward play, although the risk might have gone up a notch with the Form 15 filing.  That said, quick trading opportunities that present themselves - as it did Tuesday - help to reduce the risk.

Each investor now has to decide whether it's worth holding onto those base shares to see what develops.

I'll still be holding some of those, but the trading shares are coming out.

So now that the company is not required to file, I guess the quarterly report is no longer overdue?

Disclosure:  Long BIEL.

Tuesday, April 19, 2011

BIEL: Quarterly Results Overdue

BioElectronics Corporation announced last week via the corporate website that results for the fourth quarter of 2010 would be posted on April 15th, the day after the company provided the last investor update.

To date, those results are yet to be posted.

With still no approval news from the FDA - and the process still crawling along, according to the investor updates page of the BIEL website - the vast majority of any revenue realized will be coming from the overseas markets.

The company has emphasized the increased marketing efforts in both Canada and the UK - the main international markets where the BioElectronics products are approved and on sale - and it's about that time to start seeing those marketing efforts translate into sales. 



BIEL did launch a new product in Canada weeks ago, but not in time for it to make a difference in the fourth quarter 2010 results that we're waiting on, or for the first quarter of 2011 for that matter.

On the new distribution front, last week's investor update announced that CitrussTv, the largest Direct T.V. marketer in the Middle East, had placed an initial order to commence sales of the ActiPatch in its territory.  That could be a potentially lucrative deal for the company, as there's a whole lot of disposable money running around out that way, but will it translate into sales for a gadget such as the ActiPatch?

It's yet to be seen, but the potential is there.

For now, it's quarter four 2010 that investors want to see; and the international growth is paramount while the FDA treats BIEL like the fourth member of the Three Stooges.

The share price has dipped back to below a penny again, and this stocks previous trips below that mark have often been followed by significant - in terms of percentages - gains to back above a penny.

Disclosure: Long BIEL.

Apricus Trades Higher on Long Term Potential

Shares of Apricus Biosciences (APRI) were trading higher last week, once again breaching the five dollar barrier, after the company announced that it had filed with the U.S. FDA to receive an orphan drug designation for RayVa, Apricus' experimental new treatment for Raynaud's phenomenon, a condition in which the blood supply to the fingers or toes is suddenly reduced.

RayVa is currently being geared up for Phase III trials and utilizes Apricus' proprietary NexACT drug delivery technology, one in a fairly robust pipeline of products utilizing the technology.

The announcement of the orphan drug designation filing wouldn't be enough - on its own (in my opinion) - to...

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Amarin's Continued Positive Results Preview a Golden Future

Shares of Amarin Corporation (AMRN) were on the fly late last year after the company announced positive results from the ongoing Phase III "MARINE" trial for AMR101 in the treatment of very high triglycerides earlier than expected.

Shortly after delivering that market-moving news, Amarin also announced that another ongoing Phase III trial, this one entitled "ANCHOR," would also be completed and have results out ahead of schedule.

After sliding from the highs during the months following the slew of good news from Amarin, the company announced early on Monday morning that all endpoints from the ANCHOR trial were met and that AMR101 is primed to become a first-in-class treatment for high triglycerides.

It has been generally expected that...

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Thursday, April 14, 2011

Capstone Turbine, Still Making News

Although denied yet again at a prolonged period of trading above the two dollar mark, Capstone Turbine (CPST) is still making headlines.

On Tuesday it was announced that a large U.S. energy and gas transmission company is adding a C800 and C65 to its already-robust fleet of c65 Capstone C65 microturbines.

While not a huge difference maker in terms of putting this company over the top, orders such as this one demonstrate the growing confidence that current customers have with Capstone's low-emission microturbines.

The re-orders keep rolling in, which should bode well for future earnings as Capstone treks towards profitability.

Last week the company also announced that it had received an order for two liquid natural gas (LNG) microturbines. The units will be installed on a Type C Tanker and will be certified by Lloyds Register of Shipping, according to a company press release.

Orders such as this one demonstrate ...

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optionsXpress - Scary Charts

Spectrum's Upcoming Catalysts Make It An Attractive Pick

Although previously denied approval by the FDA for the use of Fusilev in treating colorectal cancer, Spectrum Pharmaceuticals (SPPI) is expecting to hear later this month as to whether the FDA will allow its use with chemotherapy treatments.

SPPI has been trading higher during the first quarter of 2011, and has doubled in price since December as the pipeline has advanced and the mid to long term potential of the company is uncovered.

Fusilev is already approved by the FDA for the treatment of Osteosarcoma, and after receiving the denial for the colorectal indication, the company filed additional data, hence the hope for reverse of course from the regulators.

Another catalyst set to take place this year is ...

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Zecco Holdings

Wednesday, April 13, 2011

Mannkind's Cancelled Meeting Has Been Rescheduled

Mannkind Corporation announced yesterday evening that its previously cancelled meeting with the FDA has been rescheduled. 

The meeting was originally cancelled last week due to a looming government shutdown, but a last-minute deal in Washington prevented an actual shutdown and the FDA quickly responded (about the only thing that organization does quickly) and rescheduled the date for May 4th.

 The quick rescheduling is a positive development for Mannkind and alleviates any fears that may have existed of the FDA giving the company the cold shoulder.

Little changes, however, in the fact that Mannkind will need to conduct an additional trial before once again seeking approval - rescheduled meeting or not.

The short term potential lies in the possibility of a partnership being announced. 

Long term, MNKD could still pay off pretty big if Afrezza is ultimately approved.

Disclosure:  Long MNKD call options.

Mannkind Denied Again by FDA

Back in January, Mannkind Corporation (MNKD) was denied yet again by the US FDA for its approval of the inhaled insulin spray Afrezza. The company subsequently laid off about 40% of its work force and shares were hammered after a conference call held by founder and CEO Alfred Mann - who has roughly a billion dollars of his own money invested in Mannkind and its flagship product Afrezza - failed to convince investors that he would front additional cash of his own to conduct the additional trial requested by the FDA as a prerequisite for approval.

Mr. Mann later clarified his statements and stressed that he - and the rest of the Mannkind staff - were 100% behind the continued development of Afrezza.

It has since been speculated that Mannkind will look to....
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Tuesday, April 12, 2011

Vanda's Fanapt Has Growing Potential With a Depot Formulation Now In Trials

Vanda Pharmaceuticals announced this week that a Phase I trial has been initiated by licensing partner Novartis to evaluate the effectiveness of Fanapt in a long-acting injectable formulation.

The depot version of the schizophrenia drug, while still a ways away from late stage trials or a commercial launch, add some decent long term value to Vanda Pharmaceuticals, as patients may find it preferable to use ae long-lasting injectible option over the oral pills. 

Those who suffer from schizophrenia often cease taking the medication on a whim, and a depot version would take that option away and possibly keep a patient stable over the long run.

That said, the only value that this trial adds to Vanda over the short term is as additional acquisition material, since the monetary benefits won't be seen for a while.  The potential value of the depot version, however, could boost Vanda's value in the eyes of a potential buyer.

The near term catalyst will be a boost in Fanapt sales, and it's worth keeping an eye out for the first quarter earnings report.  Shares of both Vanda and Titan Pharmaceuticals will benefit if Fanapt continues making headway into the billion-dollar-plus schizophrenia market.

Another catalyst could be an update on the status of international approvals.

I still like TTNP as the better buy between the two, mainly because Titan has Probuphine in the final stages of development, but VNDA also holds some long term value at the current prices, in my opinion, as well as being a possible takeover candidate.

It could be Novartis was just waiting to see how much penetration Fanapt would attain before pulling the trigger on a deal.
Disclosure:  Long TTNP.

Briefs: AVNR's New CCO, EPCT In Danger of Delisting?

AVNR:  Avanir Pharmaceuticals announced on Monday the appointing of a new Chief Commercial Officer.  William Sibold, who has years of experience in biopharmaceutical sales and marketing, will fill the newly-created position for Avanir and head the efforts for the upcoming commercial launch of Nuedexta.

Nuedexta is the first FDA-approved treatment for pseudobulbar affect (PBA), a neurological condition that leads to spontaneous episodes of laughing and/or crying.

The company also improved its long term outlooks by announcing the filing of an IND with the US FDA to initiate a Phase II trial measuring AVP-923 in the treatment of central neuropathic pain in patients with multiple sclerosis.

Mr. Sibold will lead Avanir's charge on the Nuedexta front, but this company still has an evolving pipeline and has added potential as a merger or acquisition candidate.

Disclosure:  Long AVNR.



EPCT: Epicept Corp. has announced some positive developments over the past few months, including a Crolibulin Phase II trial and a Ceplene approval in Israel, but none of that was enough to spur EPCT into sustaining enough upward momentum to remain within the listing standards of the Nasdaq. 

The company announced last week that it had received a notice of delisting from the Nasdaq, but Epicept plans to appeal the decision, an action that will keep EPCT trading in the status quo until a final determination is finalized.

Epicept announced a reverse stock split a while back, and one would have to believe that there is a distinct possibility that the same could occur again, given the threat of delisting. 

That said, this company has enough potential materializing for it right now to keep it on the radar, and management is making progress at a pace much better than when I decided to sell my entire position in the company after months of inactivity.

It's rare that stocks perform to the upside after reverse splits are conducted, so barring any decent news - it's likely that EPCT would slip again after an RS was announced.  If there is good news to be released, I'm more inclined to believe it would be announced before the company had to implement a reverse split, in an effort to knock the share price up another notch.

Still like the potential here, but it's worth noting the negatives involved with a delisting and/or a reverse split.

It would be an encouraging sign if Ceplene sales in Europe were picking up steam.

Disclosure:  long EPCT.

1 gram Pamp Suisse Gold Bar .9999 Fine (in Assay)

Monday, April 11, 2011

CVM: Multikine Trial Approval in India

CVM:  The around-the-world approval announcements for the Multikine Phase III trial continued last week as the company issued a press release stating that approval to begin enrollment had been authorized by the Indian medical regulatory agency.

India, according to the press release, has the highest number of cases of head and neck cancer than anywhere else in the world, so Cel-Sci expects that patient enrollment in that country will come at a pace much quicker than what would be expected in the United States.

The approximately 15 sites that will enroll patients in India also bodes well for approval over there, although it may not be a wise assumption to bank too much on the Multikine potential in India, where poverty and corruption rule the day - much more than anything else.

There has been just one site approval announced within the United States for Cel-Sci, that being in Mississippi, but it's unknown at this time how many enrollments in the trial have taken place.  Some investors are still wary about the path that Cel-Sci has taken, in terms emphasizing the trial overseas, when the focus should be on US approval - and that might also mean focus on US enrollment.

Cel-Sci spends the time and money to issue press releases rebuffing Internet rumors, but it's my opinion that a positive update on enrollment would win the PR battle a lot better than a 'Letter to Shareholders' would; the fact that we have not seen any enrollment numbers will have legitimate investors more sceptical than Internet rumors do.

That said, the risk/reward behind Multikine is huge.  There are some big names attached to the trial, and the mark left by DNDN on the market after Provenge announced Phase III results was near historic, so this is a story worth watching.

The India connection won't be what makes Multikine, but it's another in a long line of site approvals announced by the company.

Disclosure:  Long CVM.

Free Fast

CTSO: Cytosorbents' Friday Slide, Thanks to Medgadget?

Intended for publication on VFC's Stock House only.  No re-publications authorized.

After a week of rebound and volatility, shares of Cytosorbents dropped right back into the high twenties during the last half day of trading on Friday.  The drop was accompanied by a sharp increase in volume, especially right around the three o'clock time frame that cemented the day's decline.

Also on Friday, the website webGadget.com published a short, but negative, article about Cytosorbents which may or may not have led to the decline of the CTSO share price.

It's my opinion that negative articles such as this one do not along cause sell-offs or spikes in mentioned stocks, because most investors do enough DD to support their investment decisions and wouldn't be influenced by such shoddy 'reporting'.  But I do think that the big boys like to use articles such as this as a technique to create enough doubt around a company to convince the more unconvinced and fence-sitting investors to sell into the decline that is created by - not the article - but the manipulative actions of whichever entity wants the share price lowered.

This article by medGadget, in particular, reminds me of the slash job on Dendreon that took place in 2010. 

With DNDN, CNBC made a curiously-timed "reporting error" that induced a sharp decline in the share price.  Then, a short time later, an anonymous email came to the attack which only added to the manipulated uncertainty behind the company that had just received FDA approval for the cancer vaccine Provenge.

That dip, much like the one that CTSO is experiencing right now, created quite the buying opportunity for those that might have missed out on the initial run.

Coincidence?  I don't believe in coincidences like these.

The medGadget report is anonymous, just like the anonymous email that attacked Dendreon. 

Additionally, there is more space devoted to the Cytosorbents press release than there is to actual commentary - and the commentary is weak, at best, and relates to the anonymous opinion that CytoSorb may not receive FDA approval.

The truth is, anyone looking towards FDA approval understands that it wouldn't be a short term catalyst anyway.  The immediate potential of this stock is based on the European approval and commercialization of the product that is due to take place later this year.  To go negative on the subject of a potential FDA approval right now is a fruitless and almost irelevant argument, and it looks more like someone is trying to paint a negative opinion of the company, while ignoring the positives that have - and could - still take place.

I've mentioned it a few times since the approval of CytoSorb in Europe that this announcement caught a lot of people and potential investors by surprise.  Additionally, many who invest in the biotech sector these days actually wait on the sidelines for news to hit before jumping in - makes for a more "sure thing" investment over the long haul. 

However, in order to still get in at a good price after positive news hits the wires, the shares need to be forced down. 

Is this all my opinion?  Yes, but take a look at the shady price action of AVNR just an hour before releasing positive news last year, not to mention the shady action of Dendreon on numerous occasions over the years, including my above-mentioned example of how anonymous emails and articles can play a role.

We all know that this manipulation and shady activity takes place.  Not only is each and every week accompanied by an SEC-related arrest these days for stock manipulation, but the kingpin himself, Jim Cramer, is all over the Internet describing how easy it is to manipulate the markets.

The truth is, it's not entirely a bad thing.  If that is what's going on behind the scenes with the CTSO share price, then the little guy is able to pick up shares for a discount as well. 

Regardless of how medGadget or any other anonymous entity tries to swing this one, the fact is that Cytosorbents just released some milestone news for the company.  To gain CE Mark Approval before all the data was in has me believing that the data that the regulators did see was pretty convincing.

The potential of this company and its flagship product is pretty significant, and I'm not even considering the FDA right now, as medGadget did.

Dilution could become a factor, granted, but so can potential partnerships and a commercial launch later this year.

I wouldn't be too concerned with the Cytosorbents slide.  There's still quite a bit of time between now and revenues, so that means that there's still quite a bit of time for volatility - but that doesn't take away from the potential.

Disclosure:  Long CTSO.

eToro

Tuesday, April 5, 2011

NVDL: Novadel Rising - Or Falling?

Shares of Novadel Pharma have been all over the place since the announcement of the Zolpimist launch in the United states a couple of months ago, but a recent financing event caused the stock to dip enough to where I thought it was a decent speculative buy.

Since the financing, the stock dipped even lower for a while but rebounded sharply this week, more than doubling in price on Monday - before declining - and then rising again on Tuesday in quick fashion.

There was nothing significant enough in the arena of news to justify such a jump, but it was noticable that a whole new lot of sweet talking NVDL lovers were dispersed to all corners of the Internet to tell how great a pick it was and that a dollar was a near certainty in the short term.

The excess hype and effort being put into pumping this stock was enough to incline me to take the profits and go, because at that point, the stock isn't moving on a relevant news event, it's doing what the swing/momentum/day traders and whatever fund might be involved want it to do.

If you're in before those guys show up, you can do pretty good, but by the time they show up they've generally already built their positions, so by the time the mass-hysteria-hype spreads, it's too late for the little guy to buy.

Does Novadel have a good story going on? 

Recent developments have again made it an intriguing, but still highly speculative play, although I'd written the stock off over a year ago.  If the developments play out, then there definitely is the potential upside that the 'get pump crew' has been telling everyone and anyone this week, but I'd rather let the news talk and the hype walk.

There's a huge difference between pumping a stock and being positive a stock, and right now the pumping has gone berzerk.  This 'get pump crew' is pumping almost on the scale that the Celsius Holdings 'get bash crew' in terms of effort, although the Celsius guys have put in thousands of hours of Internet time to fulfill their agenda.

Could be that I miss out on a further run with NVDL right now, and that's fine - I always stress not getting too greedy and I'm satisfied with the profits that were already there.

Once the hype dies down, I'll reassess.

For now, this guy's on the sidelines while the big boys play their games.

Disclosure:  No position.



Generex's New Website

GNBT:  Generex issued a press release on Tuesday morning announcing the publishing of the company's new corporate website.  According to the press release, the new website is more in line with the new courses of action and visions of new CEO Mark Fletcher.

The information contained within the site (http://www.generex.com/) is solid, but the large circles spinning around at the top of the page are a little distracting and unnecessary - especially since they're located right at the part of the page where your eyes look first.  Make sure you check out the page BEFORE the Goose starts flowing, otherwise the dizziness will have you reeling.

The press release also emphasizes the company's move to social media to keep investors up to date.

It looks like the new administration at Generex is putting shareholders a little higher up on the totem pole than the previous one, but it's results that talk, not new websites.

The most immediate news that needs to be heard right now is what the FDA has to say about the Oral-lyn trial - back to the drawing board?  Enroll more patients?  Those are the glaring questions right now.

That said, it should be encouraging to shareholders that the new regime actually acknowledges that they exist.

Disclosure:  Long GNBT.

Zecco Holdings

BioDelivery Announces Full Enrollment in Phase III BEMA Bup

In October BioDelivery Sciences (BDSI) announced positive Phase II results for BEMA Buprenorphine in the treatment of chronic pain, and it was announced on Tuesday morning - barely five months from the announcement of a positive Phase II - that full enrollment in the Phase III trial has been reached.

In mid-February the company announced the 50% point for enrollment, and these trial milestones have BioDelivery moving ahead in line with previous estimates of a third quarter 2011 results release and an early 2012 NDA filing with the FDA.

According to the press release issued by BDSI on Tuesday morning, "BEMA Buprenorphine has the potential to be the first oral transmucosal form of buprenorphine to treat chronic pain in the U.S.".

Additionally, the market for the treatment of chronic page is a multi-billion dollar market in the US alone and BEMA Bup, if approved, has the potential to reap in up to half a billion dollars in sales per year.

Definitely lofty potential for this company and its stock, especially considering that the current market cap is still under one hundred million.

It's expected that ONSOLIS will also become a revenue factor later this year once BioDelivery and commercial partner Meda finalize the REMS issues with the FDA.

BDSI is still a sleeper pick while trading at the current levels.  Developments are unfolding at an expected clip, and since the impressive run to nine bucks a couple of years ago and the subsequent drop, there's been relatively little movement to the upside.

Some biotech stocks trade towards their long term potential and some don't - that's just the way the sector works and a lot of it depends on who's involved with the trading (hedge fund, large investor, Jim Cramer, etc.).

BioDelivery is one that is still not trading anywhere near its long term potential, in my opinion, and when this one finally does move, it should move quick.

Still accumulation time.

Disclosure:  Long BDSI.


Capstone Banking Additional Orders

It's been a volatile ride for Capstone Turbine (CPST) since the Presidential mention a couple of weeks ago, but the new trading week opened with some more positive press on the orders and distribution front.

An early morning press release on Monday announced that a Capstone distributor, Pumps & Service, has secured an order for six more C1000s, an announcement that comes on the heels of some large orders and re-orders to open 2011.

According to the press release, this is the...

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FreeCreditScore.com

Afraid of the CTSO Price Slide? Think Again.

Note:  This post is intended for VFC's Stock House only.  No repostings or reproductions are authorized.  Link-backs are authorized.

It hasn't been all sunshine, rainbows and candy floss for shares of CTSO since the company announced what should be considered blockbuster news last week with the CE Mark Approval of CytoSorb in Europe.

After plugging away at prices that approached the fifty cent mark shortly after the news was released on Thursday, CTSO started to slip backwards and reached lows of under thirty cents to open the new week.

As I've mentioned a few times since approval, the pullback shouldn't come as a surprise since the approval news caught many off guard and there will undoubtedly be quite a few investors who want to get in for as cheap as possible.  The big players can 'play' the stock to allow that to happen.

Additionally, the retreat will be supported by the swing/momentum/day traders who will take their significant gains off the table over the short term and be gone.

There's two ways to look at this situation right now, as we know that pullbacks after positive news announcements are not uncommon.  Let's look at it from the point of view of having purchased shares long ago for prices just north of a nickel and then look at the potential of CTSO as a new investment.

The sharp spike and quick decline over the past few sessions are another prime example of how holding onto - and then selling - some 'trading shares' can pay off over the short term while still holding a position for the long term. 

That said, not everyone has the time to sit in front of the computer all day and wait for the opportune time to sell or buy back in, so you've got a bunch who play the 'buy & hold' approach - or set limit sells for higher prices, but each individual spike is different, sometimes limit sells don't accurately reflects what happens with a stock post-news and the investor either cuts his or herself short or has the order set too high.

So where does that leave CTSO right now?  At thirty cents, was it a missed opportunity for those long-time holders who didn't sell any shares or is this a prime re-loading spot?

Again, the slide should have been expected because the news was unexpected - at least it was at the time it was released, so those who missed the initial boat will want in.  The stock gets driven down and then they get in.

There may be some out there who believe that the drop is the result of pending news that might not be so good and is getting priced in now. 

I'm not in that boat.

I think that it is a very significant fact that the European regulators approved CytoSorb so quickly.  The data gathered so far must have been solid and undeniable, in my opinion, to warrant such a quick approval - even ahead of the most optimistic of company expectations to this point.  Additionally, the product was approved for indications involving increased cytokines - not just for severe sepsis; that serves as another hint at the strength of the data, in my opinion.

If that's the case, then CTSO still has a lot of room to move to the upside, whether the product is approved anywhere else or not.  I think that this slide is temporary and that the trek towards a dollar will soon be in full effect - barring, of course, any unexpected bad news - once the traders are out and the longs have taken their positions.

The move higher can be fueled further and faster with the release of additional positive developments, such as positive data from the secondary endpoints or a partnership/distribution deal.

The only possible negatives at this point would be weak secondary endpoints, but even so - the product is still approved and will be on the market later this year. 

Dilution could also serve as a detractor, but the potential growth of CytoSorb on the market should limit the damage done to the share price if dilution were announced.

It's up to each and every investor to devise their own trading strategy and entry/exit points, but the current slide shouldn't be a concern, in my opinion, and should be looked at as a potential buying opportunity if shares sink low enough.

For CTSO, 2011 is already a year to remember, but the best may yet be to come.

Disclosure:  Long CTSO.

Zecco Holdings

Avanir (AVNR) Boosts Its Long Term Potential

Avanir Pharmaceuticals opened the new trading week with news that it has filed an Investigational New Drug application with the U.S. Food and Drug Administration to begin a Phase II trial for its investigational drug, AVP-923, in the treatment of central neuropathic pain in patients with multiple sclerosis.

The product is also being tested in a late-stage trial for diabetic peripheral neuropathic pain and has been approved as Nuedexta late last year for the treatment of pseudobulbar affect, a condition characterized by spontaneous and uncontrollable laughing and/or crying.

Nuedexta is expected to become a first-line treatment for PBA since there is effectively no....

CLICK HERE FOR COMPLETE ARTICLE.....

CarRentals, LLC

CELH: Fourth Quarter Numbers Hit the Wires


When Celsius Holdings released the results for the fourth quarter of 2010 on the last day possible during the following quarter on 31 March, it was pretty easy to surmise why the company would hold onto those results for so long.

The numbers were negligible, especially when compared to previous company expectations for the fourth quarter of 2010, mainly because of large returns of unsold product to Celsius by a few big retailers.

Needless to say, 2010 was a year to forget for Celsius Holdings, at least in terms of meeting projections and gaining a foothold in the mainstream beverage industry.  Will 2011 be any better?

On one hand there is no way that you can spin the late 2010 numbers to the positive - no way at all - but on the other hand the company should well know which niche the Celsius product fits into and where it is - or isn't - selling. 

That will help tremendously in corn-holing the product to places where it can be most successful.

Celsius will need financing, so that fact also deserves to be kept on the front burner.

It's no wonder that the kids running the fund that has played with the CELH stock haven't smashed it down to the sub-dime levels yet, but that's not to say that they won't. 

The company won't stay quiet forever, so expect to hear something from the management team in the coming months.

Celsius is still a good product, but it's going to take some work to put CELH on solid growth footing again, in my opinion.  I do believe it can be done.

Worth the rebound play?  Even with the bad news the stock went from the mid-twenties to sixty cents pretty quickly, but keep in mind the highly risky and speculative nature of this play right now.

Keep it on the watch list.

Disclosure:  Long CELH.

From Weekly Stock Watch at VFC's NEW Stock House.

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