Alabama based, Biocryst Pharmaceuticals' stock got a near 80 percent bounce Friday based on the news of a successful Phase III study of the companies intravenous flu drug, Peramivir, sponsored by the Biocryst's partner Shionogi & Co. Ltd. in Japan.
The study shows that iv Peramivir is equivalent to Tamiflu.
While "Fast Tracked" for approval by the FDA, there was no comment from the FDA Friday about progress.
Friday the CDC also raised expectations of a heightened flu season beginning with the school year. The particular emphasis was on H1N1 which Peramivir can treat.
Two facts should spur the FDA on their "fast track" approval of this drug. The facts are the number of people who have died from H1N1 so far and the school year begins in mid August yet supplies of Tamiflu are set to be ready late September.
Biocryst and its partner have sufficient manufacturing capacity to produce Peramivir in sufficient quantities to protect more people.
If a single person dies from the lack of speed of the FDA "fast track" of this drug then the Obama
administration should indeed make an overhaul of the FDA a priority along with its health reform plan.
http://www.biocryst.com
http://www.biocryst.com/peramivir.htm
http://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=264815
http://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=224367
http://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=232486
http://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=200449
http://www.bizjournals.com/birmingham/stories/2009/07/13/daily40.html
http://online.wsj.com/article/BT-CO-20090717-708264.html
http://www.medicalnewstoday.com/articles/157996.php
http://www.biohealthinvestor.com/2009/07/biocryst-data-makes-it-more-of-a-threat-to-roche-glaxo.html
Comments
Why dont you check with the experts at Biocryst.com they can help you faster than I can.
If you have the resources to get the 19 year old to Japan- Bicrysts affilaiate company there may be able to help you now. They may even be able to send the drug to the hospital in the US.
I know of no US doctor who would touch this. The FDA prefers Tamiflu and are in the first phase of testing another vaccine. Of course this will be too late.
I know nothing of any legal precedent that alllows compassionate care use of any drug in the US. I have seen no mention of Peramivir in that context nor can I foind any such reference in that context anywhere. Please name your source and contact them - maybe they can help.
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