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Biotech / Medical : GenVec - GNVC
GNVC 7.1930.0%Jun 26 5:00 PM EST
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To: traderdad46 who wrote ()3/12/2010 10:15:09 PM
From: Gary Mohilner  Read Replies (1) of 106
 
I don't doubt that forces bigger than private investors would like to bring or hold GNVC down either until they get rid of their short position, or establish long positions cheaply. I don't believe they'll have any control once the data is out if the data's positive, which I believe it will be. The real question is how positive.

To me there are many levels of positive, the most is one which leads directly to approval on the data from 184 events. The least positive is having the FDA say they want more after 276 events before they'll approve the drug.

I don't believe this drug can totally fail to be approved, it offers results that are too good in to many cancers. Delays are another matter, the FDA has delayed many drugs which became blockbusters over time, but occasionally they do it the other way. The last time I remember such action Gleevec was approved on the strength of preliminary data on just over 70 patients.

I'm not saying the FDA will simply look at the data from the DSMB and approve the drug, but I'm also not suggesting that approval will be delayed. We never know what the FDA is likely to do. The one thing I'm certain of is approval cannot occur until commercial quantities of the drug can be made in an FDA approved facility. GNVC may have some options in getting this done, but if 184 event data's worthy, manufacturing will be on the critical path.

Gary
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