“However, in play are 3 other RA's outside the USA and anyone or all of them could very well disagree with the FDA if from their perspective they find the results to be satisfactory.”
Absolutely correct, and a big thank you to LP for INSISTING that more than just the USFDA was pursued for approval, unlike the other board members.... it could make a huge difference.
Granted that the FDA's thumbs down would be a blow. However, in play are 3 other RA's outside the USA and anyone or all of them could very well disagree with the FDA if from their perspective they find the results to be satisfactory.
What three would those be?
There is a point to this question that will go ignored.