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FDA Watchlist - (AMEX: HEB)
By: Michael Vlaicu   Friday, May 08, 2009 11:50 AM

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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 investment as these companies are poised to rise leading up to the decision.

Risk: You lose up to 40% as seen from DSCO and VION.OB 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.

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.


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The above story is the opinion of the author only and it does not reflect iStockAnalyst opinion. Further, the author is not personally advising you regarding the suitability of the story for your investment needs. In no event iStockAnalyst will be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from or arising out of, or in connection with the use of this information. Please consult your investment advisor before making any investment decision.
  
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