For many this is starting to look like a soap opera, but contrary to the TV version, this is extremely exciting. Obviously, we’re talking about Hemispherx Biopharma (HEB) and the big question will the FDA give its thumbs up to bring Ampligen to the market.
The introduction to the next episode was given on Tuesday morning when HEB issued a press release saying the FDA may require one or two additional weeks before it reports to the Company. As you may remember, the PDUFA date (the target date for the FDA to report to a company) was May 25, 2009. The reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report.
Another item that was mentioned in the release, and what we found very interesting, was the fact that the FDA didn’t request additional information from Hemispherx at this time.
The release triggered a tremendous amount of speculation on the message boards of various websites as to what it meant and if it was a good or negative signal by the FDA.
The following days, also a number articles were published by informed and… not so informed authors. Underneath we’ll give you a short run-down.
A very helpful and informative article was published on Wednesday by The Pink Sheet DAILY titled Hemispherx’s Ampligen Poised To Become First Approval For Chronic Fatique Syndrome. The Pink Sheet DAILY is a news service for and about the pharmaceutical industry.
Next came Thestreet.com, which published Hemispherx’s CFS Drug Is a Long Shot. Thestreet.com is one of those big media outlets for which we warned last week. These guys simply cover “HOT” stocks without having the necessary background or knowledge. Thoroughly researching a complicated biotech company like Hemispherx takes days. Time, most of those writers don’t have. So they quickly look up some facts, form an opinion and start writing.
And let’s face it, who can blame them. The article undoubtedly attracted thousands of visitors to their website and that’s what matters. Is the analysis wrong or right? Who cares. The next hot stock is already waiting to be written about.
Finally, on Friday we had another excellent editorial by BioMedReports.com, titled: The Plot Thickens for HEMISPHERx Biopharma.
No matter who writes what, we’ll have to be patient some more to find out what the FDA has to say.
What do you think, will we see approval this week?
Photo credit Brandon Cirillo