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Sunday, May 29, 2011

Stocks to Watch: CPST, CTSO, GNBT, DDSS

MOVED TO:  http://vfcsstockhouse.com/blog/article/-stocks-to-watch-cpst-ctso-gnbt-ddss




Wednesday, May 18, 2011

Cytosorbents: Some Cautious Statements In The 10k

MOVED TO:  http://vfcsstockhouse.com/blog/article/-cytosorbents-some-cautious-statements-in-the-10k

ONTY: As Stimuvax Trials Winding Down, Price and Volume Spike Make It One To Watch

MOVED TO:  http://vfcsstockhouse.com/blog/article/-onty-as-stimuvax-trials-winding-down-price-and-volume-spike-make-it-one-to-watch

Zecco Holdings

Significant Developments at Cel-Sci

MOVED TO:  http://vfcsstockhouse.com/blog/article/-significant-developments-at-cel-sci

AVNR's Nuedexta: Signs Of A Dud?

MOVED TO:  http://vfcsstockhouse.com/blog/article/-avnr-s-nuedexta-signs-of-a-dud-

Mannkind's Drop After Earnings Call, Time To Run Or Time To Buy?

MOVED TO:  http://vfcsstockhouse.com/blog/article/-mannkind-s-drop-after-earnings-call-time-to-run-or-time-to-buy-

Tuesday, May 17, 2011

Voting For The Generex Reverse Split: Yes, No, Or Is There Another Option?



MOVED TO:  http://vfcsstockhouse.com/blog/article/-voting-for-the-generex-reverse-split-yes-no-or-is-there-another-option-

optionsXpress - Workshops and Seminars

ACTC Could Be A Game Changer Over The Long Run

MOVED TO:  http://vfcsstockhouse.com/blog/article/-actc-could-be-a-game-changer-over-the-long-run

BIEL Announces Unaudited Reports

BIEL:  In another 'Investor Update' on the company's home page, BioElectronics announced that the 2010 fourth quarter and 2011 first quarter unaudited financial results were out and posted to the OTC Markets page. 

Sales for the first quarter were $375,436, according to the unaudited filing, up fairly significantly from the $281,767 from the same quarter during the previous year.

While sales were up, they weren't up enough to demonstrate to BIEL investors that the company is poised to survive based on international sales growth alone.  Expenses and losses are still there, and it's going to take a significant growth in sales to offset those facts.

Given that BIEL's 'Investor Update' was pushed back to Monday to allow time for Arnon Horev, the VP of Sales & Marketing, to return from his presentation at the European Medical Device Distributors Alliance (EMDDA) meeting in St. Petersburg, there was nothing noteworthy enough released that would justify any built-up suspense that waiting over the weekend would have caused.

BIEL is suffering from 'little guy' syndrome right now.

Not only has the FDA given the company the cold shoulder for well over a year now, but the auditors don't seem to be in too much of a hurry to help these guys out.  Such is the life of a small player in the big leagues.

That said, if - and with each and every day the big "if" is growing - the FDA does ultimately approve the BioElectronics products as 'Class II' medical devices, then the over-the-counter clearance in the United States could be what saves the company and propels it to the next level.

In the meantime, investors are treading water and keeping an eye on international sales, which could provide the means to keep the company afloat for a while, assuming that the growth continues.

Also keep an eye out for some hype.  Once again a true sub-penny stock, there's always the potential for signfiicant gains to be realized if the stock gets hyped enough.

That said, there's a lot of shares out there and there's a perceived lack of interest from the FDA at bringing these products to market.

Disclosure:  Long BIEL.

Siga's Contract Award Marred By Another Protest

Keep an eye on Siga Technologies this week. The company announced after the closing bell on Friday that it had signed a much-anticipated agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services to deliver an initial two million doses of the antiviral smallpox vaccine ST-246 to the nation's stockpile of biodefenses.

The awarding of this contract is the culmination of over a year of controversy for Siga, as the road to the award has been marred by a rollercoaster ride of events, including seeing Siga land the contract once before, only to have it derailed by protests filed by a competitor.

Since that time, BARDA took measures to alleviate any perception of unfairness in the contract-awarding process, even going so far as to investigate the status of Siga as a "small business" -- but the same competitor, Chimerix, Inc., came out of the woodwork this weekend and again filed a protest with the Government Accountability Office over Siga's receiving the contract.

According to a press release issued on Sunday by Siga, BARDA plans to defend its decision of the contract award, but all progress will be halted while the government reviews the case. The review could last up to 100 days.

CLICK HERE FOR FULL ARTICLE

Monday, May 16, 2011

Briefs: CVM Commences Trial In Poland, SIGA Receives Contract Award and Then A Quick Protest, MedClean Partners With Covidien?

Also see VFC's News, Notes & Weekly Stock Watch.

CVM:  Cel-Sci issued a PR on Friday announcing that the Phase III Multikine trial has commenced in Poland, the first site in the European Union to open.  The trial also arrived in the New York Tri-State area last week, and it's expected that close to 900 patients from around the globe will ultimately be enrolled.

SIGA:  Siga announced this past Friday that it had (again) been awarded the much anticipated contract with BARDA to stock the national reserves with a small pox vaccine.  The initial phase of the contract is worth nearly half a billion dollars to Siga, with the potential for the contract to be worth $2.8 billion over its life.

Just as quickly as the contract was announced, however, the ever-menacing Chimerix filed a protest which will delay proceedings until the proper authorities have the time to review the case.

This game has been played before, and BARDA went back to the drawing board to ensure fairness in the award, so it's highly likely that the situation will still play out in Siga's favor.

SIGA shares were up by nearly two bucks in the after-hours on Friday, but the re-invigorated uncertainty surrounding the award thanks to Chimerix may create some volatility.

MCLN:  MedClean announced last week that it had established a relationship with Covidien to promote its products.

"This relationship is our largest co-promotion arrangement to date, broadening the exposure of our products and connecting MedClean with nearly every hospital in the country," commented David Laky, MedClean's President and CEO in a press release issued Friday morning.

Increased promotion could evolve into increased sales numbers, which still makes MCLN an appetizing long term, speculative pick, but for the time being, the best option may be to continue viewing MedClean as a 'trading play'.

SIGA: Contract Awarded, Time For A Move Higher

MOVED TO:  http://vfcsstockhouse.com/blog/article/-siga-contract-awarded-time-for-a-move-higher


Tradersroom

Sunday, May 15, 2011

Are Avanir's Sub-Par Sales Numbers An Early Sign Of A Nuedexta Dud?

Shares of Avanir slipped 7% Tuesday, following an earnings release that saw revenue from the recently approved Nuedexta rake in only $505,000.

Nuedexta, a treatment for pseudobulbar affect (PBA), which is a condition characterized by spontaneous fits of uncontrollable laughing and/or crying, was approved last year and has been on the market since February.
As a result of the earnings release, various slick-worded headlines have hit the wires, headlines from blog sties that almost doom Avanir to failure, while some analysts have also stutter-stepped, tap-danced and backed off previous projections.

It's my opinion, however, that the immediate reaction to the underwhelming sales of a product that has been on the market for significantly less than one full quarter is just a bit overblown, and may have more to do with the rather significant percentage of shares short on the stock than the actual pattern of Nuedexta sales - if you can call two months enough time to establish a pattern.

CLICK HERE FOR FULL ARTICLE

optionsXpress - Workshops and Seminars

Saturday, May 14, 2011

APRI Spikes Leading Into Earnings

Shares of Apricus Biosciences (APRI) broke through the $6 barrier during Tuesday's trading day, before falling back to close at $5.92, up four cents from the previous close. The recent move to the upside could be considered a fairly significant one, given that the APRI stock was trading for two dollars lower just a few months ago.

Additionally, shares were trading for a buck less than the current levels just a month ago, when Apricus announced that one of its fairly robust pipeline of products was being geared up for a Phase III trial.

The upside move followed a press release issued by Apricus before the market open on Tuesday announcing that the quarterly earnings conference call would be held on Friday morning, with the numbers due to be released before that time.

The earnings call should hold no surprises for investors, as revenue from sales is not expected to become noteworthy until next year when Vitaros is expected to have infiltrated the Canadian erectile dysfunction market. More likely, investors will be looking for updates regarding the potential of Vitaros around the globe - we've noticed a potential market in the Middle East - and the progress of any partnership talks that may be taking place.

CLICK HERE FOR FULL ARTICLE


Yahoo! Small Business

Thursday, May 12, 2011

Readers Respond: SPPI's Falling Price


"Readers Respond" is a forum where VFC responds to comments, questions and/or concerns posted by readers of VFC's Stock House and VFC's NEW Stock House.  Readers can leave comments on posted material at either of the blog sites, through my Seeking Alpha inbox or via email, vfc@vfcsstockhouse.com.  All stock opinions, tips and questions are welcomed, whether agreeable with VFC's opinions or not - it's all about discussion, not all about everyone being on the same page.  Call it like you see it.  Thanks for the comments, because without interaction - this wouldn't be fun.



An email to my Seeking Alpha page regarding the post-approval price decline of SPPI: 
Hi VFC,


I am relatively new to the game. I am following the biotech industry and currently SPPI. I was hoping you could enlighten me on how, after an FDA approval and continued earnings reporting, their price is continuing to fall. Maybe I am missing something. Please, any quick bit of info would be helpful to me.


Thanks,


John

SPPI:  Investing in the biotech/pharmaceutical sector is a world all in its own, especially when dealing with relatively small companies, compared to the big boys on the block.  Having a couple of approved products on the market already, Spectrum is a little ahead of many other small biotechs and small pharmas out there who are still awaiting their first FDA approval, but even SPPI is susceptible to the sometimes uncanny trading patterns of the sector.

It's worth noting in the first place that seeing shares of a company in this sector decline after announcing good news is not a new phonomena.  Most recently, Cytosorbents released what should be considered blockbuster approval news, spiked higher and then lost 50% of its market cap off the highs.

In other instances, BioDelivery Sciences experienced a strong run-up into approval news, before coming back down to earth and stocks such as DDSS, AVNR, AMRN and numerous others have quickly retreated after posting pre-approval gains.

Some of this can be explained simply by the old 'buy the rumor, sell the news' strategy, which still plays out in the market every day, mainly by day/swing/momentum traders and short-term minded investors.  Additionally, shorts have been known to jump on top of large spikes in this sector and push prices down to a more attractable buying price.  It's a safer bet - with a lot less risk - to buy a stock after the good news is out - especially when the price gets knocked down to pre-approval prices, and it's become apparent that the big boys have been playing that strategy over the years.

Because there is such a long period of time between a product being approved and it actually returning significant revenue, the hedgies and the big boys can play a stock at will until solid earnings prop it up enough to maintain a stable level.

The small investor shouldn't be afraid of these price actions, rather I think the little guy should play along with the routine and just pick up some of the crumbs.  A handful of 'trading shares' can come in handy during the runup to news, but if the big boys want the stock down on the back end of the news - then that's just as good a time to buy as it is for anyone else; especially given that the little guy tends to have a more long-termed outlook.

After buying into the post-approval dips, it's a patience game to see if the product pays off.  It took JAZZ a while to take off, but look at that baby now.

Another point to consider is that this sector is easily manipulated - by hedge funds, big-money investors and even by media outlets and high-profile blog sites.  For instance, is it a coincidence that the compiled-blog site TheStreet.com's biotech blogger issued a negative piece on Spectrum on the morning of the day that the positive news came out?  That's up for each individual to speculate on his or her own, but history has it that some of these glorified bloggers issue negative reports at quite opportune times - and when the news is plastered each and every day with new market manipulation and insider trading cases being tried by the SEC, it's almost a safe assumption that every stock you invest in is being manipulated to play to someone's benefit.

The big boys are going to play their games and eat their cake (and a growing number of them are starting to eat their cake from behind bars - like the fat guy who was on the news yesterday for insider trading, he ate a whole lot of cake), the little guy is happy just picking up some crumbs and paying for that next vacation, or for a semester of the kids' college, or for wifey's new pair of Prada.

As for SPPI?  The additional Fusilev approval is good news for the company.  Anyone spinning a drug approval as bad news for a company should go work for Glenn Beck or Rachel Maddow - the spinners supreme.

Disclosure:  No position.

ShareBuilder Rveal 336x280 Banner

Wednesday, May 11, 2011

Readers Respond: New Investor Questions

"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.



An email to VFC's NEW Stock House (vfc@vfcsstockhouse.com):

Hello VCF:

I dont know your real name, but i started following your columns recently, as i have taken an interest in investing in stocks. I have been reading a lot and, the truth is the more i read the more i get confused and nervous. compared to some other reporting, i found your reports to be more factual and reliable. You put a sense of reliability and honesty in your research and perception.

Personally, i dont feel confident to jump in the ocean of trading stock by myself! I have been looking at some paid advisory services, but cannot make up my mind. I would like you to assist me in this matter. Firstly, do you offer a paid service in stock picking and trading? secondly, if not, does Seeking Alpha has a paid service? Third, could you suggest a few services in your opinion have a good reputation?

Please consider this as simply giving a bit of guidance to someone who is confused and lost in this new world of Trading Stock.

Greatly appreciate your time.

Sincerely,

Babu

VFC's Take:  Appreciate the email.  The name is VFC.

VFC's Stock House does not offer a paid stock tipping service, nor do I engage in paid advice services, qualified financial advisors are available for that. 

The intent of VFC's Stock House is to offer a starting point for ideas about different stocks and companies, the leg work of in-depth DD should be conducted by each individual investor.

For new investors, I alwasy do suggest Jim Cramer's Real Money book.  I'm not much a fan of Cramer because I believe his empire is all about his own ego, and the guy is all over the Internet talking about how easy it is to manipulate the market.  That makes him a rat to all his hedge fund buddies and a borderline criminal to everyone else.  His books are good and inisightful reads, however, so take a gander.

Also, I've written some of my own lessons learned a while back, links below:

Investing Lessons Learned

Exercise Patience

Where to Start DD

Investor Questions - Don't Get Greedy

Everyone comes up with a different style, based on, among many other factors, risk tolerance and time available for research and investing.

Good luck on whatever you decide to do, and I'm not the one to come to for recomendations of pay services, as I don't pay much attention to them.  I'm a fan of good, old fashioned DD conducted by the one who is your own best proponent - you.

Zecco Holdings

Readers Respond: Titan 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 Nick to my Seeking Alpha inbox:

I enjoy your articles and would like to know you opinion on TTNP. I know you are long but can you give me your estimate on the stock price 12 and 24 months out? Seems like it's still a buying opportunity with big upside potential and minimal down side risk. Looking to start a position.

Thanks

VFC's Take:  Last mentioned on this week's News, Notes & Weekly Stock Watch entry at VFC's NEW Stock House, I've followed Titan heavily over the years, and continue to foresee good things for this company and its share price.

What was once a promising pipeline evaporated after failures from Spheramine and Iloperidone (now approved and marketed as Fanapt).  Titan dropped to mere pennies for a while before recovering in fine fashion following the surprise approval of Fanapt

Currently, Titan is raking in an 8% royalty on sales of Fanapt - which hasn't been flying off pharmacy shelves, but it's free money for Titan - and has Probuphine on the back end of a confirmatory Phase III trial that was partly funded by the NIH. 

As for price targets, there's too many factors that play into price movements in this sector to make accurate predictions.  Additionally, it's too easy to become fixated on price targets, where I believe the real number that small investors should be watching is percentage gains - that's a better way, in my opinion, to gauge whether or not you're getting too greedy with yourself.

But I won't completely dodge the question - two years from now I expect that Titan will have been bought out.  If that is not the case, then the share price is really going to depend on the terms of any partnership deals for Probuphine, as dilutive financing will play a large role in the future share price if a partner does not ante-up some up-front.

Over the short term, I can see TTNP reaching and surpassing the two dollar mark leading into the release of results. 

Thanks for the email, and when assuming that there is little downside risk, keep in mind that Titan had a full pipeline of potential a few years ago and at one point, it looked like they had all failed and the stock went from the three to five dollar range on the AMEX to penny land on the pinkies overnight.

Probuphine looks good, and money is rolling in from Fanapt, but we're not out of the deep water just yet.

Thanks for the email.

Disclosure:  Long TTNP.




Readers Respond: MNOV, MBX.to, AVNR, RNN

"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 Adrian:

Hi VFC - like your style, a lot. You call it how you see it!


Like your write up on RNN and will take a position soon, wanted to get your take on MNOV. Per Management about to ink Big Pharma deal for MN-166 a novel MS/Diabetic Pain drug going into Phase IIb. Their other lead candidate MN-221 is a BLOCKBUSTER first in class Asthma drug completing a phase IIb by end of year. Very low float and cap, fairly well capitalized, just retired a pile of debt. A few Analysts on the call and a $12.50 (400%) price target as per average Analyst targets.


Also I own AVNR - what do you think of its prospects?


Finally, don't know whether you look at Canadian Biotech at all but Microbix Biosystems (MBX) is about to become a 5 bagger by the Fall. 10 bagger in early 2012. 20 year Company, 10 years public, 50 employees, $6 million core base business growing (20%/year) selling viral products. Major pipelines include deal with Hunan Biopharmaceutical to build World's 3rd largest vaccine plant. Phase I capitalized and underway, completion 2013. Second, Lumisort for sexing semen of cattle, instrument entering ($200 million) market by Q2 2012, no legal barriers, several distribution agreements already signed. Third, in discussions with several large Pharmas to partner Kinlytic (Abbokinase) the clot busting drug formerly owned by Abbott and $300 million in sales, pulled from market due to manufacturing issues. Microbix has the rights to this FDA and Health Canada drug and is looking to re-enter. Should conclude a deal in Jume-August timeframe. Shares out 55 million. marlet cap $16 million.


Appreciate your comments.


Adrian

VFC's Take:  Thanks for the email, appreciate it.

MNOV:  MediciNova has built a pipeline based on acquiring the rights to products from mainly Japanese companies through licensing deals.  Of the eight product candidates - being developed to treat ten different indications - the company is focusing its efforts on two of the most advanced, which are - as Adrian pointed out - MN-166 for MS/pain and MN-221 for acute exacerbations of asthma. 

Both indications hold significant potential on the market, although both are still to be considered Phase II products, leaving a long way between now and market.

With a market of under forty million, there will be room for MNOV to move to the upside, in my opinion, as the pipeline develops - and if a partnership materializes as, as Adrian eluded to, then that would alleaviate some fears of dilutive financing, which could still be a possibility.

Decent speculative pick - reminds me a bit of ELTP, a company with multiple licensed products that can move quick on the right news.

MBX.to:  At first glance, I like MNOV better than Microbix, although MBX has huge potential if the business plan works out.  While the products and pipeline are certainly promising, I'm sceptical of the joint ventures taking place in China.  I don't trust anything regarding small companies and China since that country has become a 'safe haven' for start-ups looking for a place to pump business deals that never materialize. 

I think of that company Hard to Treat Diseases - a definite 'too good to be true' Chinese pump and dump.

Additionally there's no way for us to confirm anything going on in China.  The economy is false, the people work as essentially slaves and corruption is rampant.  So I'm sceptical when small companies claim to have business deals going on over there.

That said, there's enough business with MBX that does not rely on China, so it's worth taking a peek to see if it pays off.

Thanks for the email and for throwing a couple of new stocks into the mix!

I'll take a look at both a little deeper.

Regarding AVNR, I like it for the longer term.  I should have an article out on Seeking Alpha before long regarding the stutter-stepping analysts and 'doom and gloom' outlooks that came from blogs at the Motley Fool and TheStreet.com based on two months of sales.

Disclosure: Long AVNR.

Zecco Holdings

Titan: Will The Run Continue?

From News, Notes & Weekly Stock Watch posted Sunday at VFC's NEW Stock House.

TTNP:  Titan has retreated somewhat from the highs of its most recent run, but the pending Probuphine confirmitory Phase III results keep it as a stock worth watching.

Increases of the past have seen TTNP slip back to below the $1.50 mark, but the retreat has not been that significant this go-round, at least not yet, which could be a sign that investors are taking the potential Probuphine news seriously this time.

There's been a lot of speculation surrounding the recent Deerfield credit announcement, especially since Titan relinquished 2.5% of Fanapt royalties to get the deal done, so investors will be looking for news, announcements or updates as to what Titan has in store for the short, mid and long term.

Still, I maintain my stance that the company will be bought out once the Probuphine results are known.

Any significant dips would be a time to add, in my opinion, but barring another drop to $1.30 or so, I like where we stand.

Keep an eye on it, I think we'll see a surge to above $2 leading into the results.

Disclosure:  Long TTNP.

StartLogic Hosting - $4.95 a month.

Tuesday, May 10, 2011

Avanir: Still One To Watch

From News, Notes & Weekly Stock Watch posted Sunday at VFC's NEW Stock House.

AVNR:  Nothing materialized from Avanir last week in terms of price movement, although heavy trading again last Friday will still keep investors glued to developments from this company, whose Nuedexta was approved last year for PBA.

The commercial launch of the product is underway and the company has also initiated a patient registry that could be viewed as a demonstration that management is on the ball regarding maximizing the market potential of Nuedexta.

AVNR has been a heavily-shorted stock, and the boost in volume - double the normal average on Friday - could be an indication that shorts are covering.

The company is set to announced earnings this week, and any positive comments regarding guidance have the potential to lift shares after hovering around the four dollar mark for a while since the post-approval highs.

Still one to watch.

Disclosure:  Long AVNR.


EPCT: Not Out Of The Woods Yet, But The Long Term Potential Shaping Up

So far Epicept's claim to fame has been receiving an approval for the AML treatment Ceplene in Europe and in Israel.

Although sales for the product were "not material", according to the most recent quarterly announcement, Ceplene is partnered with Meda AB in Europe and with MegaPharm in Israel.  The company does not expect to see significant sales growth from this product until next year, when the reimbursement and approval authorizations are finalized in the individual countries of the EU and the commercial launch in Israel is in full effect.

In the meantime, Epicept has taken a step forward towards approval in the United States. 

The company announced on Monday that it had filed the Phase III protocol with the FDA, and expects to receive initial comments from the regulators within 45 days.  Once the final protocol is established, then the Phase III trial can commence, but it's not likely that we'll see that until at least late this year.

Epicept has already been granted an Orphan Drug designation in the US, giving the company seven years of exclusivity on the market, once (if) approved.

Another milestone to watch for Ceplene will be the release of interim results from the post-approval trial taking place in Europe.  These interim results are due out later this year.

The rest of the pipeline is also shaping up, and may hold even more potential than Ceplene.

After announcing positive Phase IIb results for the topical pain creme NP-1, now known as AmiKet, Epicept is looking to partner the product to bring it through Phase III and to commercialization.  According to this week's earnings announcement, partnership talks are in the works.  I will note, however, that it took some time for Epicept to partner and commercialize Ceplene, so history says that investors could be waiting a while before seeing an AmiKet partner.

The next two product candidates may hold the most future value.

A Phase II trial for Crolibulin was initiated last year by the National Cancer Institute (NCI) as a treatment for anaplastic thyroid cancer (ATC).  Results from this trial could start rolling in as early as late 2011.

Azixa is currently being tested in Phase II trials for glioblastoma multiforme (GBM) in coordination with licensing partner Myrexis, with some data from this trial possibly being released within the next couple of months.  EPCT has moved significantly in the past on positive Azixa news (although the moves were short-lived), and should this product move to Phase III, the case for EPCT as a nice long term pick becomes a little more legitimized. 

Additionally, Epicept will receive a milestone payment from Myrexis upon the first patient dosing in Phase III.

The pipeline looks solid, but the financing - not so much.

As has been the case in the past, dilutive financing events should be expected, pending any significant income from partnership deals.  I wouldn't hold my breath waiting for the big partnerships, however,

Another reverse stock split is also not out of the question.

That said, EPCT is still a decent, but speculative, 'buy the dips' kind of play.

With a few trial milestones due this year, it'll be one to keep an eye on.

Disclosure:  Long EPCT.

eToro

Cel-Sci's Multikine Phase III Arrives In The Big Apple

Cel-Sci Corp. announced via press release on Monday morning that the Multikine Phase III trial, which the company states commenced in Mississippi last year, will now be available in the New York Tri-State area. 

"The New Jersey Medical School and Veterans Affairs Medical Center is ready to begin immediate enrollment of qualified patients that desire to participate in its Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer," reads Monday's press release.

This PR is more relevant than others from Cel-Sci that announced various site approvals around the globe, because it's the second site announcement for the United States.  Until now, it looked as if the company was concentrating significantly more emphasis on expanding this trial internationally than it was at home, and while that still may be the case, at least Multikine will now be available in a major population center of the United States. 

The fact that the location is near the US's First City - what I like to call the capital of the world - is just a bonus, and there's far more of a chance, in my opinion, of recruiting patients in the New York area than than some little towns in Mississippi, if only for the sheer population numbers.

An announcement of "ready for patient enrollment" is far different from one that would read "first patient enrolled", but another Phase III site in the US does add additional legitimacy to the trial.

Additionally, any advertising on the Tri-State airwaves for the Multikine trial, much like Titan's advertising for the Probuphine trial, could also bring attention to the company, and its stock, as well as the trial.

With the potential of Multikine as a first-line treatment for head and neck cancer, one that is also "off the shelf" and does not need a sample of a patient's cells to create, CVM should be looked at as a decent risk/reward pick for those playing the cancer immunotherapy market.

Cel-Sci also has LEAPS in the pipeline, but progress on that front has been silent since the end of the H1N1 epidemic.

Disclosure:  Long CVM.

Sunday, May 8, 2011

Stock Watch: MNKD's Earnings

From News, Notes & Weekly Stock Watch posted Sunday at VFC's NEW Stock House.

MNKD:  All eyes will be on Mannkind this week, right from the get-go, with a Monday earnings release and conference call scheduled that will have investors looking for an update on the FDA meeting that should have taken place last week.

Additionally, and maybe more importantly, insight into a pending partnership may be given, and many investors are playing the odds right now that a partnership will be announced.

The stock has fallen significantly since the last earnings announcement when Mannkind cut about 40% of its work force, but it could be a rebound play if partnership news materializes or positive indications of an eventual Afrezza approval are announced as a result of the FDA meeting.

The old adage goes, that good news is usually reserved for early in the week in the stock market world, so investors will be glued to the Mannkind press wire on Monday morning.

I'm not sold that partnership news is imminent, although I respect the possibility, but I do think that MNKD is worth a few shares because the FDA did not outright deny Afrezza, moreso they wanted confirmation that the next-generation inhaler works.

Adding mystery and anticipation is the fact that there has been no update from the company about the meeting that was to have taken place last week.

Worth watching.

Disclosure:  Long MNKD.

Friday, May 6, 2011

Briefs: KERX's Potential Yet To Be Realized, RNN Trial Update

Originally posted at VFC's NEW Stock House.

KERX:  It's been a few months since KERX has been mentioned on VFC's Stock House, but it's worth paying attention to as both of the company's late-stage products hold significant potential.

Zerenex is a Phase 3 product being tested for efficacy in treating hyperphosphatemia in patients with end-stage renal disease on dialysis, and Perifisone, another late-stage KERX product, is being investigated in Phase III trials for the treatment of refractory advanced colorectal cancer and multiple myeloma.

The potential of the two products make KERX a potential huge mid to long term pick, but with milestones pending with Phase III trials, there might be some short term potential as well.

KERX still has a market cap of under $300 million, a level from which shares should appreciate significantly should one or both of these Phase III products meet measure in trials and advance to market, and a stock offering this week has sent shares tumbling down into the mid-fours again.

This could now be an opportune time to add again, as a runup into the trial results is possible.
Some good news came out of Europe this week, when Keryx was informed that additional trials would likely not be needed in order to receive approval for Zerenex.
A recent press release from KERX read:

"Zerenex is intended to treat high phosphate levels in patients with chronic kidney disease. Keryx is seeking approval to market the drug for use by patients with chronic kidney disease who are not yet on dialysis, and patients with end-stage kidney disease who are undergoing dialysis."

With two potentially lucrative late stage products on the go, and with the post earnings/stock offering dip in effect, KERX is one to eyeball heavily right now.

Disclosure:  No position.




RNN:  Rexahn announced this week that it is at the two-thirds mark for enrollment in a Phase II trial testing Serdaxin for major depressive disorder (MDD).
RNN had dipped earlier in the year, following a nice runup, after a stock offering was announced, but even after stock offerings, which dilute shareholder value, the potential of the pipeline cannot be forgotten.

And Rexahn has some potential.

Archexin and Zoraxel are also being developed for pancreatic cancer and erectile dysfunction, respectively.

RNN is not in the clear by far, however, with all product at Phase II or earlier, but the potential for gains and spikes is there with a current market cap of one hundred million.

The risk for downside is there, as well.  Not only does this company have to take the risk that its drugs may not pan out, but TheStreet.com's biotech blogger has gone to work on Rexahn before, and that guy likes to fire salvos at the companies he doesn't like. 

Maybe he's got a buddy that runs a short-side hedge fund that'll need a hand one day and another RNN hack job will materialize, who knows.

Investing in this sector is all about measuring potential risks against potential rewards, and this one has a pretty good risk/reward profile right now, in my opinion.

Disclosure:  No position.
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Mannkind: Silence Before The Storm?

Mannkind (MNKD) was set to meet with the FDA this week, a re-scheduled event after having the meeting cancelled last month when it looked like the U.S. government was on the verge of a shutdown, but shareholders have yet to hear about what took place during the sit-down.

The meeting between Mannkind and officials from the regulatory body was a chance for the company to discuss the FDA's denial of approval for the inhaled insulin spray Afrezza, which was announced in January, and to identify a plan for moving the product forward to market.

According to information published at the time of the denial, the FDA wanted to see proof that Mannkind's next-generation inhaler worked as well as the inhaler used during the already-completed late stage trials.

It looked like, at least at that point, that Mannkind would certainly need to conduct additional trials and get that information to the FDA before approval would again be considered.

The bottom dropped out of shares of MNKD at that point, and even further when the company shaved over 40% of its workforce in an effort to reduce costs and streamline resources towards an eventual Afrezza approval.

However, even with the setbacks, the potential for an eventual Afrezza approval never wavered.

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Thursday, May 5, 2011

CTIC: Cell Therapeutics' Pixantrone News - Reverse Split Next?

CTIC:  Cell Thereapeutics received news on Wednesday from the FDA regarding a review of the previous denial for the company's cancer drug, pixantrone.

The news, although encouraging in term of the company's point of view, still make it look as if Cell Therapeutics is going to have to conduct an additional trial to ultimately receive approval.  To the company's credit, the FDA left open the possibility that a fast track approval was still a possibility if some issues with the data from the previously conducted trial could be resolved.

From a biotech stock speculator's opinion, however, it looks like the near term risk/reward right now does not favor an investment.

Not only was the pixantrone news not too encouraging - unless you're the company PR guy - but this stock is primed for a reverse stock split.

Reverse stock splits are rarely a positive undertaking for a company, at least not for the short term, so it might be worth sitting on the sidelines here until we see a post-RS dip, because most likely, that's what we'll see.

CTIC is still developing its pipeline, however, so there is definitely still some mid-to-long term potential, but the prospects of the reverse split make it a risky play right now.

With a market cap of roughly $350 million and a share price of thirty-something cents, it's hard to imagine a significant price increase even if good news were released in the short term.

I'd 'Watch List' this one for the time being.

Disclosure:  No position.


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BRIEFS: Avanir's Patient Registry, CVM Trial Approved in Poland

AVNR:  Following heavy trading late last week, Avanir made VFC's NEW Stock House's list of Weekly Stock Watch this week.

Thus far, nothing exciting has developed from AVNR trading, but with a significant amount of shares short, a volatile move either up or down could materialize in the not-so-distant future.

On Wedensday, Avanir announced that is would establish "the PRISM patient registry, the first patient registry to further quantify the prevalence and quality of life impact of pseudobulbar affect (PBA) in patients with a variety of underlying neurologic conditions," according to a PR issued by the company.

While the establishment of this registry will not immediately effect the company's bottom line, it is an indication that management is determined to maximize the future potential of Nuedexta in PBA, and potentially additional indications.

The heavy short interest still has this one as one to watch.

Disclosure:  Long AVNR.

CVM:  Cel-Sci announced on Wednesday that the company has received a green light from the regulatory authorities in Polond to commence the Multikine Phase III trial in that country.

If recent history is an indication, then we should see a TheStreet.com biotech blog post anouncing that this PR is the 'Sweet Seventeenth' PR on the subject of site approvals.

You can almost hear the biotech blogger chuckling in the backround counting to 17 like the count on Sesame Street back in the day.

Disclosure:  Long CVM.

Wednesday, May 4, 2011

DDSS: Reality Still Sets In

Originally posted at VFC's NEW Stock House.

DDSS:  While the possibility still exists that Labopharm is still a decent speculative mid to long term play, I bailed on DDSS earlier this year after the stock or company failed - for too long, in my opinion - to make any progress on anything.

Since then, the company has laid off staff and undertaken a 'strategic review'.

Earlier this year investors held hope that an approval in Canada for the major depressive disorder (MDD) drug OLEPTRO would breath new life into the company - and possibly the share price - but according to the most recent update from the company, there are no plans to pursue commercialization of the product in Canada.

OLEPTRO has also not gained much traction in the United States since announcing FDA approval for the product early last year. 

The Intellitab and Polymeric nano-delivery systems drug delivery technology still hold potential longer term value, in my opinion, which could make DDSS still a decent long term play, in my opinion, but right now Labopharm is barely keeping its head above water.

Still worth a watch list look, but until something gives, DDSS has little market-moving events to offer.

As always, this is just my opinion.  Each investor should conduct his or her own DD and invest accordingly.

Many speculated correctly at the time, but it looks like Labopharm and Angelini were not a match made in heaven.

Disclosure:  No position.

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Is SIRI Bullish or Bearish From the Two Dollar Mark?

Shares of SIRI closed nearly ten percent to the upside after posting yet another solid quarter of earnings and revenue growth in its rapid road to recovery since hitting rock bottom in early 2009, when the global economy as a whole was on the brink of disaster.

SIRI closed the day Tuesday at $2.07 after having set a new 52-week high at $2.09, a solid increase. Shares closed the day Monday at $1.91, down nine cents from the open, in trading that saw volume three times the daily norm.

All that volatility reinforces SIRI's reputation as a trader's dream stock, while the sharp short and long term increases have also made winners of those that consider SIRI a
long term hold.

In the first quarter report, SiriusXM added 373,064 subscribers, bringing the subscriber base to 20.6 million. CEO Mel Karmazin left year-end guidance unchanged, and admitted that the guidance could be considered conservative, although it has yet to be seen how much influence the natural disasters in Japan will have on the supply of the U.S. auto market. SiriusXM draws a significant amount of business from new car sales, so a downturn in that market could put a damper on the company's potential for new revenue.

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Briefs: GNBT - Antigen Express Study Published, ONTY - Stock Sale, DNDN - Earnings

GNBT:  Generex announced this week the publication of results of studies conducted in collaboration with subsidiary Antigen Express and the University Campus Bio-Medico in Rome.

The studies, entitled, "Recognition of Ii-Key/MHC Class II Epitope Hybrids Derived from Proinsulin and GAD Peptides by T Cells in Type 1 Diabetes," according to a company press release, and are "applicable to the early diagnosis, and possibly treatment of, Type 1 diabetes."

The results appear in the April issue of the international peer-reviewed journal Hormone and Metabolism Research.

The real short term potential market-moving event for Generex would be word as to whether or not the FDA will allow results from the Phase III Oral-lyn trial to be used as a basis for approval, given that the trial did not enroll the originally intended number of patients.

Additionally, a vote on a reverse split is due to take place, and Generex has outlined the strategy moving forward in the event an RS does - or does not - take place.

GNBT has been idle for some time, but come vote time, things could get interesting.

Disclosure:  Long GNBT.

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ONTY:  Shares of Oncothyreon have since retreated after rising to over five dollars recently, on news that the company has conducted a stock sale that raised $40 million.

According to the company press release, the funds will be used "to fund the development of PX-866, Oncothyreon's PI-3 Pan-isoform irreversible Kinase inhibitor, and ONT-10, Oncothyreon's proprietary follow-on vaccine to Stimuvax." 

Stimuvax is a cancer immunotherapy treatment currently being tested in a Phase III trial for non-small cell lung cancer and is partnered with Merck KGaA.

Oncothyreon remains a candidate to become 'The Next Dendreon', in terms of hitting the market with a splash by having a cancer vaccine approved.

Keep in mind, however, that most cancer vaccines fail in the pursuit of approval, so although the rewards look good - don't ignore the inherent risk.

Disclosure:  Long ONTY.

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DNDN:  Dendreon (DNDN) continues to chip away at the lofty expectations predicted by the company and analysts for this fiscal year, as first quarter revenue numbers were reported as coming in at just over $28 million.

Shares of DNDN had been on a steady rise throughout the first quarter, as higher earnings numbers were expected once the FDA approved additional manufacturing capacity at Dendreon's New Jersey Provenge manufacturing facility.

The true benefits of the additional manufacturing capacity, however, were not expected to be felt until the second quarter of this year as the work stations are being brought online in a phased approach.

Dendreon issued evidence to that fact by announcing April revenue of $15 million along with the first quarter numbers. Already, just one month into the second quarter, revenue has exceeded half that of the first quarter, offering a glimpse that full 2011 revenue expectations of $350-$400 million may be achievable.

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RPC, CELH, SIRI: Wall St Cheat Sheet At It Again

RPC:  Earlier this week I took note of the fact that the stock symbol for Celsius Holdings (CELH) was receiving extra attention by popping up on the headlines of earnings reports for the big player in the beverage industry - namely Coca-Cola, Pepsi and Dr. Pepper. 

Turns out that 'The Wall St Cheat Sheet' has a habit of listing all 'competitors' of a subject company in their reports, hence the widespread dissemination of their publishings and - ultimately - the widespread clicks on their material.

Celsius isn't the only company of note to pop up in that regard.

This week the WSCS published an article citing companies whose insiders were known to be selling shares.  RPC was not the subject of the headline, although that headline appeared under the RPC stock symbol - which, one could argue, is highly misleading, since RPC would only have been a competitor to the companies of subject in the article.

WSCS issued a correction on the May 3, however, stating that the RPC stock symbol was misrepresented and should have been the symbol for RPC, Inc.

Radient offered news last week that the recently concluded trial for its Onko-Sure in vitro diagnostic (IVD) cancer test was positive, with results due to be published in a peer-review journal at some point in the future.

The Nasdaq also recently granted the company a listing extension, as was requested by Radient.

There will be quite a bit of drama surrounding Radient for a while, at least until the whole story is told and announcements of legal action are settled, and it's worth keeping an eye on the stock as the price swings have been significant.

SIRI:  SIRI announced another solid quarter of earnings growth this week, and shares crashed through the two dollar mark on the news.

One of the best recovery stories out there since the depths of the financial crisis - when SIRI trading for about as much as a Bazooka Joe bubble gum - and the run up could continue as long as the economy and the auto market rebounds.

There are some risks, however, given the chances that another economic downturn could materialize with the global instability and rising oil and gas prices; that scenario would put pressure on the US economy again.

I'm always a fan of selling a few shares into significant price runs, and I'd encourage shareholders of SIRI to congratulate themselves, and mayba take a European vacation.

Good stuff.

Disclosure:  Long CELH, RPC.

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Tuesday, May 3, 2011

Briefs: CELH, TLON, CVM

MOVED TO:  http://vfcsstockhouse.com/blog/article/-briefs-celh-tlon-cvm
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Another Large Order for Capstone

With an earnings report just around the corner, Capstone Turbine opened the new trading week by announcing another large re-order for its low-emission microturbines.

The repeat customer, identified as "one of the world's largest independent oil and natural gas companies" in the world, this time ordered an additional 22 C65 microturbine units.

The units are destined for the Eagle Ford shale play in South Texas, as were units purchased in previous orders, and brings the total to 64 microturbines ordered in three separate orders from this company.

Capstone's local distributor Pumps & Service again sold these units, according to the company PR issued on Monday morning, and regardless of whether credit goes to P&S or Capstone's products (or both), the fact is that the significant infiltration into the south Texas shale play is highly encouraging for the company and its investors.

That said, although the company announced record quarterly revenue last quarter, that trend must continue...

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Stock Watch: CTSO - Waiting on the Secondaries

CTSO:  Cytosorbents will be one to watch until the release of the full data from the European trial for CytoSorb that led to CE Mark approval for the medical device earlier this year.

There is definitely some suspicions behind the immediate reversal of the CTSO share price following a significant spike on the positive approval news, especially since shares of the stock are not being delivered to buyers, according to public sources, a good indication that naked shorting is taking place.

Why the need to naked short a stock after it has released good news?

Could be that someone wants in - someone who might have missed the boat the first time.

Any further drop to below the twenty cent mark is buy time again, in my opinion, although picking up a few shares around twenty cents could pay off as well.

Regardless of the outcome of the secondary endpoints, CytoSorb is primed to do fairly well on the market, in my opinion, because it treats an indication for which there is no real competition.

Keep an eye on CTSO - when it moves again, I've got a feeling that it will move quick.

Disclosure:  Long CTSO.



Monday, May 2, 2011

Following Heavy Trading Action, Avanir Could Be Shaping Up for Quite the Week

With the share price of Avanir (AVNR) having inched upwards all week last week on fairly heavy volume, it will be a stock to watch during the coming week.

The AVNR share price has slipped off its highs of nearly six dollars since receiving approval for Nuedexta in the treatment of pseudobulbar affect (PBA) - a neurological condition that leads to spontaneous episodes of laughing and/or crying - last year and announcing a stock offering shortly thereafter. and short interest has increased along the way as well, topping out at roughly 32 million shares short as of 15 April.

The modest rise in share price on heavy volume last week, however, could be an indication that the short shares are being covered.

It's earnings season as well, and although Nuedexta has not even been on the market for a full quarter, investors should have a chance to gauge whether earnings surprises could...

CLICK HERE FOR FULL ARTICLE

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Spectrum's Long Term Potential Grows

Last week was quite the week for Spectrum Pharmaceuticals (SPPI), and this week could be even better.
The preliminary earnings report released last week had Spectrum realizing record revenues for the first quarter. But the company also received milestone news from the FDA on Friday when it was announced that Fusilev had been approved for use in the indication of colorectal cancer.

Fusilev sales have been on the rise prior to this decision as the product is already approved for use in treating Osteosarcoma. This approval expands the potential uses for Fusilev, which should mean that the record revenues being generated by Spectrum will only continue.

Additionally, it was also recently announced that the FDA had approved Fusilev in a ready-to-use formulation, which offers doctors another option for prescribing the drug.
It's been a solid of run of good news for this company of late, and the market-moving events for 2011 are still not complete....

CLICK HERE FOR FULL ARTICLE

TLON - Will The Run Continue?

TLON:  Shares of Talon Thereapeutics (formerly Hana Biosciences) dropped by nearly 15% on Friday, after having tripled in price in just over a month.

Volume significantly increased over the last three trading days of last week as the momentum, swing and day traders probably jumped on board, and investors will be watching this one closely on Monday to see if the run continues or if it will stall at or near the $1.30 mark.

Talon's lead product candidate is Marqibo for the indication of acute lymphoblastic leukemia (ALL) for which Talon expects to apply for accelerated approval from the FDA in 2011. 

Marqibo has already been granted orphan drug designation by both the US and European regulatory agencies.

Talon is also conducting trials to expand the uses of Marqibo and has additional earlier-stage products in the pipeline.

Also, the company secured financing of up to $100 million from Warburg Pincus and Deerfield Management in 2010.

The price spike, recent trading action and growing volume will have TLON on the watch list this week.

Given the relatively developed Marqibo pipeline and the long term potential of its other products, it wouldn't be unreasonable to expect to see shares at least double over the short term.

Other just-as-speculative companies boast market caps of well over $100 million, while TLON's closed Friday at under $30 million.

Keep an eye on this one. Big gains have already been had, but some more might be in the works.

As always, each investor should conduct his or her own DD and invest accordingly. 

Investments and trades in this sector are never without risk.
Disclosure:  Long TLON.

AVNR - Earnings Due

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

AVNR:  Friday's triple-the-average-volume is an indication that eyes will be on AVNR this week, and could also be a sign that shorts were covering leading into the expecting earnings announcement, which could take place this week.

Avanir received approval for Nuedexta late last year for the treatment of pseudobulbar affect (PBA), a neurological condition that leads to spontaneous episodes of laughing and/or crying, and there have been hints that many expect sales to exceed early expectations with the recently appointed William Sibold heading up the sales and marketing efforts.

AVNR saw some suspect trading in the hours before the approval was announced, and the short interest is pretty significant, so any surprising or unexpected news could send shares significantly higher.

The company is also developing AVP-923 for additional indications, wich only adds to the long term potential of the company and its stock.

For the short term, pay attention to what the company has to say on Tuesday.

Disclosure:  Long AVNR.

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Spectrum Announces Milestone News on Friday, Heads This Week's Stock Watch

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

SPPI:  Spectrum announced on Friday that it had received approval from the FDA for Fusilev in the indication of colorectal cancer.

Fusilev has already been realizing significant sales growthgains for the indication of Osteosarcoma, and this approval only boosts the long term potential of the drug.

Shares traded down by 13% on Friday on well-above-average volume, a drop which may be attributed to some big-player speculators exiting their positions following the recent runup into the April 29th decision day for the FDA, but anytime TheStreet.com's biotech blogger is involved in a significant price drop of a biotech stock, investor suspicions are raised.

biotech blogger did, in fact, publish a negative blog posting about Spectrum before the approval announcement was made. His argument is essentially that Fusilev for the colorectal indication is a non-factor due to competition that's already on the market.

Needless to say, it's not surprising that Mr. Negativity finds nothing positive about a company receiving approval for an additional indication for an already-approved drug, but his opening comments in the article are enough to tell us that this guy's scope of reality may be slipping.

In the opening of that blog post, the biotech blogger compares the hype to Spectrum's decision day with the FDA to the hype of the royal wedding between Prince William and Kate Middleton in England.

That comment and comparison alone is a sure sign that 'delusional' is more and more becoming a large part of that guy's reality.

Where has this guy been hanging out that a drug approval compares to an historic event like the royal wedding? The level of relevance to the UK that the William & Kate marriage plays is a once-or-twice in a lifetime event, who's this guy kidding?

Truthfully, I think that the biotech blogger was just trying to impress us that there might be something more to him than the world of stock bashing and negativity that seems to consume him.

This guy's not fooled.

As for Spectrum, it'll be a stock to watch this week - as an additional approved indication is a positive event for any company, regardless of competition on the market.

Spectrum is also now in that much of a stronger position for a potential buyout or partnership agreement.

This one might just be heating up.

Any additional dips could be a nice time to buy or add.

Disclosure: Long SPPI.

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