What if they found the control arm to be tampered with again somehow. say the control arm had bavi all throughout it?
Not saying it happened but what would the FDA do? Do you really know? What if they had documented proof of the patients cells treated with bavi showed dramatic improvement.
Do you really know in today's world what the FDA would do. How could the FDA claim that the trials system can be trusted if there was tampering again? What would they do knowing that pphm had 3-4 trials where the control arm dramatically outperformed historic trials by 40%.
The FDA would be seen as a joke allowing so much coruption. What would they do?
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!
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