“What would good news look like?”
Some time ago, I posted the following:
“From what I’ve read, a good FDA result would not just be IND approval, but include as many of the following as possible:
- IIb/III trial protocols combined or dovetailed
-a low number of trial candidates, the rumoured approx. 60+ would be a great result. (Dendreon had to fund 500+)
-healthier trial candidates than in phase IIa (less degraded immune system, therefore potentially better response)
-the less trial sites (and countries involved) the better
- and most importantly a trial protocol with an end point dictating a ‘positive reaction’ to the treatment rather than a much (perhaps years) longer and therefore more expensive ‘survival rate’ criterion.”
On reflection, I now don’t see any reason to materially change any of that!
In my view, the content of this announcement will be pivotal in the future of PRR.
And I can't believe that a senior Pfizer exec would move fulltime to PRR if there was any doubt!
Good luck all.
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