vinmantoo, that was exactly the kind of thing we were all told to believe about the PII 2nd ln NSCLC PII data that suffered the dose switching by our CRO, CSM in Fargo.
The FDA was NEVER going to accept the PII data because of the DOSE SWITCHING.
Now you say:
The FDA will NEVER throw out or ignore the control arm so that Bavi or any other drug will get approved.
Why do I feel to have the benefit of the doubt here?
Because the FDA did IGNORE the Dose Switching, did give a PIII SUNRISE clinical trial approval and IGNORED IT SO MUCH that they did even give a Fast Track designation on top of it ALSO based on that SAME always called 'Butch Data'.
Apparently the FDA is not so predictable or the data wasn't that butched!
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.