I do not understand honestly. The original “concerns” the FDA has seemed like they were being asked by somebody who did not know what they are looking at.
this is the 3rd time now SI has presented very compelling slides (the same ones). Why don’t they behave like a professional and pull him up on SPECIFIC parts of these slides they disagree with so he/they can discuss.
because what he has presented seemed overwhelming. But they are not really doing a follow up on it?
this seems so weird to me.
Ryoncil: ODAC/FDA Meeting Discussion, page-669
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