Well, the FDA and regulators are not as arbitrary as you and they apparently disagree. PFS is a surrogate measure of OS that can be derived, under the proper conditions, as a surrogate measure of OS. In this case, it was clearly not possible as PFS was, as measured at that time, not fit for this kind of trial and did not serve as surrogate measure of OS nor was it apparently correlated with OS. That suggests that it was problematic and that inflammation was confused for PFS, so PFS was not diagnosed properly.
The regulators, unlike you, understand this issue far, far better and so do the clinicians, who are the top of their field and concluded otherwise. The change was made previous to unblinding, following regulations and OS is a much better measure and really the aim of the original measure of PFS.
So you're really just giving reasons for why you HOPE that they decide otherwise. You're not giving the facts as they were, and you're simply stating your own conclusions over and over again as if that is what will be found and was found. We have to wait for the regulators to decide, so your posting this over and over and over again is not productive.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
AI
