Regarding Les statement, FDA involvement from the FDA’s perspective can not directly prevent Nwbo from providing commentary HOWEVER I think Les points to the inherent risks of the FDA interpreting any part of a statement as negative to the FDA.
Since the FDA is the approver of the treatment it seems like common sense to avoid even the chance to piss off the approver or run afoul of politics, etc.
I’ve found myself in situations where a statement was taken completely or partially not as intended innocently, and imagine what those wanting to hurt Nwbo would say to distort in a negative damaging manner, like had been done previously many times as blatantly obvious merit less attacks.
Unfortunately I’m seeing and experiencing more miscarriages of justice and systems rigged with bias such as to perpetuate existing ecosystems of jobs even at the expense of what is logical and right.
So Les’s statement of cautiously avoiding running afoul of the FDA when approaching approval sounds prudent to me, fwiw and imho.
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