| Delays Keep Hemispherx (Amex: HEB) on Hold as FDA Staff Issues Come Into Play | | Print | |
| Written by M.E.Garza | ||||||||||||
| Tuesday, 26 May 2009 05:34 | ||||||||||||
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The delay has nothing to do with HEB or Ampligen and everything to do with the FDA, according to those familiar with the situation. In addition, the FDA did not request additional information. Adrienne Dellwo, who serves as About.com's Guide to Fibromyalgia and Chronic Fatigue Syndrome had this to say to BioMedReports on the topic of Ampligen's approval: "Of course, I hope that Ampligen will help a lot of people regain functionality and quality of life. With any new drug, however, it takes time to figure out just how effective it's going to be, and for how many people. On one hand, Ampligen's long, strange history casts some doubt on its effectiveness, but on the other hand some very prominent people in the CFS community have used it and believe it will change a lot of lives. "The bottom line is that people with CFS need more treatment options, and studies show Ampligen may be a very good option, especially for certain CFS sub-groups. For example, it could work wonders for someone with a post-viral case, but not for those who developed it after exposure to toxins. I hope this is the treatment for which millions of people have waited." Some are speculating that the delay may be, at least in part, due to the new appointment (confirmed by the Senate last week) of Dr. Margaret A. Hamburg, as the new commissioner of the Food and Drug Administration. The Wall Street Journal has just posted a story titled: "New FDA chief must divest several stock, fund holdings." In it, the Journal states that Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator. Interestingly, a hedge-fund sponsor Renaissance Technologies, where Mr. Brown works owned 34,500 shares in HEB and added 23,000 more recently according to the latest Mutual Fund Facts report. Hamburg is a former New York City health commissioner who also is a public health and bioterrorism expert. Hamburg told senators at her confirmation hearing that she wants to restore public confidence in the FDA by putting science first and by running an open and accountable operation. The FDA had been under criticism recently for its handling of several issues related to food and pharmaceutical products. The company says it's development plan for Ampligen continues as described in their recently filed 10q and 10k.
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Comments (3)
the otter way
said:
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Investors and CFS patients eagerly anticipating approval from the FDA on Hemispherx Biopharma's Ampligen may have to wait as much as 1-2 additional weeks for a decision according to the company's latest news release and 
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... Why would someone not remove themselves from the decision vs holding up a drug process? Isn't she saying she wants everything out in the open? This seams like a bad start for her! |
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JMTC
said:
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... the reason is two fold....................... one the FDA director was asked to rid herself of a conflict of interest. The share amount is of no significance as it is still a conflict whether it is one share or a million shares. The mere appearance is hurtful for the government and everyone involved. If a denial were imminent........... it would be less of a conflict in that the value of the shares would be much less and there would be no gain to be derived from insider knowledge. The other reason is the FDA director's husband would not be investing in a company that is about to receive a denial of a drug that would render the investment worthless and certainly not maintain the investment after it was brought to their attention assuming it was not on the radar. .......................... JMTC |
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Gharry
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... When "guesstimating" the possible share price I like to base my guess on what I believe the market cap should be. For instance, I believe the market cap for Biotech firms with one FDA approved drug on the market is 5-6 annual sales (I read this somewhere in an article about valuing Dendreon if Provenge is approved). I have no clue what annual sales for Ampligen is projected to be. I highly doubt sales would be anywhere near $500 million annually but here's just a quick analysis at different levels (I assumed 5 times annual sales to be conservative): $100 mil = $500 mil market cap or $5.90 pps $150 mil = $750 mil market cap or $8.87 pps $200 mil = $1 bil market cap or $11.82 pps $250 mil = $1.25 bil market cap or $14.78 pps $300 mil = $1.5 bil market cap or $17.73 pps $350 mil = $1.75 bil market cap or $20.69 pps $400 mil = $2.0 bil market cap or $23.64 pps $450 mil = $2.25 bil market cap or $26.60 pps $500 mil = $2.5 bil market cap or $29.55 pps Also, keep in mind that these numbers are once a drug has been on the market for more than one year so you would need to discount the price. I'd love to hear someone from HEB announce their projected sales of the drug upon approval but I have a feeling that won't happen. Oh and if you want to factor other uses for Ampligen feel free to do that too but for now I believe most of the stock's price is based on Ampligen's approval or denial for CFS. My gut feeling is that if HEB is approved the price will be in the 8-10 range. |
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