@alhambra So let’s get this right . There is a meeting with the FDA to discuss a) an EUA and b) the basis for a confirmatory trial…and before this meeting is held, you are declaring “you got it right “……which poses the question ….why are they holding this meeting ? Will the NIH or Novartis back them in a confirmatory trial ? How will institutions respond to either a) or b) being sanctioned ?
I would postulate that it is the number of patients and not the quality of the data which is the restraining factor here. Your presumption, that you have any idea what the outcome of that FDA meeting will be…i will leave to others to judge ….after all the FDA is a law unto itself.
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