Great news for Genvec. In exchange for changing the trial from 1 year survival to overall survival Genvec got a promise of early approval if interim data proved conclusive and a very minor statistical burden for those interim looks. Early interim data reported last March indicated 42% absolute gain in overall survival in the TNFerade arm vs. SOC. The endpoint hoped for 20%.
That was 51 patients. With an interim look at the first 92 or 96 patients, stat sig seems to me like a given.
This could be an approved drug in 2009.
Management's decision to throw the bucks and effort at this program at the expense of other promising programs is herewith justified.
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