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Tuesday, May 07, 2013 6:34:50 PM
In the pharma industry, no one considers a small Phase IIa as providing 'proof of concept.' The only people who try to do so work for tiny biotechs who try to frame their limited data as such. It's not that anything was done wrong, you just can't (if you want to be taken seriously) overstate the certainty afforded by a single small Phase IIa. We have seen too many small trials that failed to replicate when expanded. That's why I suggested HOC--there's something that hints at therapeutic effect, but it has yet to be 'proven.'
NP
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