Hemispherx Biopharma, Inc. (HEB) has been all over the map in 2009. If you’ve been following the stock, you would have seen it go from 50 cents to over $4 and now back down to $1. HEB already sports the FDA approved Alferon but has been delayed several times on an approval for CEO Dr. William Carter’s life long work, the drug Ampligen. It would be the first approved drug to treat the previously ignored, chronic fatigure syndrome, which is very real and very detrimental to many people’s lives. There has also been talks of Ampligen being helpful with H1N1 virus.
Until recently when Dr. Carter was interviewed, investors had been left in the dark as the FDA decision has been pushed back and little communication coming from HEB. The CEO finally revealed that HEB has been in contact with the FDA and working together on the application. The FDA had questions on Ampligen’s toxicology, which will require more clinical studies, and also completed audits on HEB’s clinical sites and manufacturing facilities. The FDA found nothing wrong with the clinical sites but there were some compliance issues in the manufacturing facilities. HEB is in the process complying with both items on the FDA checklist to obtain an approval. Dr. Carter estimates HEB will have the required information submitted to the FDA in the 4th quarter and then the ball will be in their court once again.
It seems to me that this is a joint effort between HEB and the FDA to seal the deal. The FDA realizes the significance of having no approved cures for CFS. Together, they are writing the blueprint for the first drug of it’s class. I think we do see Ampligen approved early 2010. I’ve made money on this stock with some day and swing trades in the past but I will be looking to get back in for the serious gains before New Years.
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