FDA Watchlist – HEB
May 8, 2009
Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 3000%, and 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these choices.
Moreover, for those who are not high on risk tolerance, investing up to the FDA approval date may still be a very smart choice as these companies are poised to rise leading up to the decision.
Risk: You lose up to 40% as seen from DSCO and NFLD if approval is declined.
Now let’s move onto my first choice:
Hemispherx BioPharma, Inc
(Public, AMEX:HEB)
About: Hemispherx Biopharma, Inc. (Hemispherx) is a biopharmaceutical company engaged in the clinical development, manufacture, marketing and distribution of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. The Company’s products include Ampligen and Alferon N and Injection. Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as a vaccine enhancer(adjuvant) for both therapeutic and preventative vaccine development. Alferon N is an indicator for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is an application under early stage development targeting influenza and viral diseases. Ampligen is an experimental drug undergoing clinical development for the treatment of CFS.
FDA News: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09.
Ampligen is a synthetic specifically configured double-stranded RNA containing regularly occurring regions of mismatching. Ampligen and Oragens experimental nucleic acids are being developed for the potential treatment of globally important viral diseases and disorders of the immune system including HPV, HIV, Chronic Fatigue Syndrome (CFS), Hepatitis and influenza.
My suggestion for you is put a small amount you can afford to lose, i.e. 15%-30% of your portfolio and tomorrow you could be either sitting on 2000% gains, or 40% loss. Either way, it is worth rolling the dice on these gems.
—-
By reading StocksHaven Investments you agree not to hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
Random Posts
Posted in Daily Picks
content rss
May 8th, 2009 at 10:42 am
Awesome pick thus far. I bought at 1.01 and it’s at 1.17 this afternoon (and climbing)
May 8th, 2009 at 10:46 am
@Josh, yes indeed; Next week I will have a new BioPharma pick, this month will be FDA Month.
May 8th, 2009 at 11:36 am
Are you looking to hold this right up to the release date?
May 8th, 2009 at 11:37 am
@Grant, I will make a decision on that depending on how much it rises. A good idea might be to sell the day before while keeping a small position upon FDA news. This way you are maximizing your risk vs. rewards potential.
Remember to always facilitate the best available option for you. It all depends on the type of rewards you are looking for. Long-term 500%+ gains, or short-term 3000% possibilities.
May 8th, 2009 at 3:18 pm
How would you find out ahead of time whether they’ve got the FDA approval or not?
May 8th, 2009 at 10:46 pm
Thanks Michael. I thought VION.OB’s FDA date is not until 8-17. Why did you put in the same boat as DSCO and NFLD?
May 8th, 2009 at 11:03 pm
@Sammy, you are correct.
Vion Pharmaceuticals, Inc. (VION) announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin(TM) (laromustine) Injection has received a standard review classification by the U.S. Food and Drug Administration (FDA). Therefore, a user fee goal date of December 12, 2009 for a decision by the FDA with respect to the approval of the Company’s NDA has been established.
I miss read the news, that was just for a priority review. FDA is set for Dec 12, 09.
@Houman, lol no.
May 9th, 2009 at 8:25 am
Thanks. This is what I have for VION:
4/17/09 is date for FDA to accept the filing and rule on priority review request – if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.
May 9th, 2009 at 8:29 am
@Sammy, Indeed the date has passed for priority review and I assume it was declined as their latest articles all state 12/17/09 as the prime candidate decision date.
May 9th, 2009 at 1:31 pm
Yep, you are absolutely correct. http://www.tradingmarkets.com/.site/news/Stock%20News/2288155/
By the way, both HEB and ACUS shot up yesterday, are you still recommending a buy on these next week or has the train already taken off?
May 9th, 2009 at 1:44 pm
@Sammy, I expect both of these to rise steadily up to the FDA deadline. From there on I suggest you keep about 10% of your current position through to the results, as there is a potential 40-60% drop vs. 500%+ climb. This way you profit either way.
May 11th, 2009 at 4:34 pm
HEB deadline is memorial day. Market and FDA shut for business. Some people are talking about a release of info the week prior to the date. This statement is not backed in any way shape or form, just an FYI. Im holding HEB as of this morning.
May 11th, 2009 at 10:11 pm
I’m holding HEB and CTIC until the end of the month or until the news. I’m hoping at least one pays off. What kind of pattern are we looking at the next couple weeks until the news is released. strong spikes with the rest of the time slowly going down, or should be looking for continuous climbing.??? New to this kind of trading. Mike, let me know what you think.
May 13th, 2009 at 9:37 am
Is today the right time to buy HEB? Is there other pharma stocks that waitng FDA approval look good. I am new at this, I would really app. everyones help.
thanks
May 13th, 2009 at 11:40 am
most you would pay for heb now?
May 13th, 2009 at 11:59 am
@Wayne, As per SEC Rules and Regulations I do not have the authority to express “how much I would pay”. My company writes articles based on my assumptions as an investor on companies I see best fit the scenario of “undervalued” and “future potentials”. Sorry for any inconvenience, but it is up to you to do your own DD and make your own decisions.
May 14th, 2009 at 8:52 am
when is a good time to get in with labopharm?
June 11th, 2009 at 1:41 pm
[...] is up 121% on Hemispherx BioPharma (AMEX:HEB) since the initial buy on May/8/09 found at FDA Watchlist – HEB | Investors and instutional buyers continue to show interest in small cap Biotechnology & Drug [...]
August 18th, 2009 at 1:12 am
[...] Hemispherx Biopharma, Inc. (+ 52% as of May/8/09) [ Article Link [...]