"I think point 3, especially the words used by FDA - "regulatory perspective" cannot be understated. Also, please note that the FDA clarified the intent of the original question - it was not that they said we need to add a new question."
I also noted that the phrasing of the question coincides with the requirements for FDA approval, so there is no equivocation with regard to the vote. This is an overwhelming success for the company,their patients and investors.
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