Biotech Values

[DewDiligence]

Re: Why so many phase-3 failures

Agree with all of your points. My post was addressed to this observation by Cougar in message #42782:

“It seems to me that there are way too many failures on pivotal Phase III failing to meet their primary endpoints after these drug candidates produced stellar Phase II results [emphasis added].”

I interpret “stellar phase-2 results” to mean that the phase-2 programs in question were robust. Thus, in my reply I was answering the question of why phase-3 trials in the aggregate do not live up to their phase-2 promise even within the universe of phase-2 programs that were relatively large and well-designed.

When you add to the mix phase-2 trials that were small and ones that “cheated” on some design element, then naturally the failure rate in phase-3 is magnified accordingly.