WHY, then, can PPHM not apply this same logic with the FDA for approval?
I do not disagree with your logic. However, if Bavi did/does work, the trial design must have been flawed if a 'fail' is officially the result. As many have pointed out, management let us all down here and it's their fail, not a Bavi fail. Therein lies the issue.
I believe Bavi does work, but our team can't figure out how to prove it,.....and I can't help but think the other stopped trial (in 2015) due to an 'outperforming control arm' was also a mgmt fail.