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Replies to #56975 on Biotech Values

daved

01/03/08 5:17 PM

#56998 RE: exwannabe #56975

Re Genvec: 1) The FDA probably asked for the change to overall survival. It's the gold standard and easily understood and appreciated by every oncologist. I assume the company went along with the request because, in return, they have a good chance at earlier than expected positive results with application approval based thereon + interim peeks with minimal statistical burden. That reduces their cost. A change from 1 year survival to overall survival will surely include the early patients because the trial protocol remains unchanged. Those patients were sure to be maintained beyond 1 year because of the incidental beneficial interim results.

2} Don't you find it compelling that 7 of the events came from the 18 SOC segment and only 5 from the 34 SOC + TNF side?

3) from the subsequent press release:

http://www.genvec.com/download/press/TNFerade%20INTERIM%20EFFICACY%20RESULTS%20RELEASE_12182006_FINAL757667_1).pdf

You know that calling it a single patient difference is a gross distortion of the trend illustrated by these early results.

Dave