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Home > , , , , > GNVC / FDA could stop trial and approve with current rate

GNVC / FDA could stop trial and approve with current rate

2:49 PM Posted by MH

According to the most recent press release from GenVec, the PACT trial will have a next interim look at the data after 92 events, and 184 events. The FDA could stop the trial if significant efficacy presents itself. At a first look at the data in late 2006, the TNFerade group showed an absolute response rate of 70% vs 28% SOC group. If the response rate holds at the next look in late 2008, there is no valid reason for the FDA to continue the PACT trial. It should conclude immediately and seek to approve TNFerade.

A bit old news but great article

http://seekingalpha.com/article/60655-genvec-inc-the-biggest-little-biotech
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