Thanks Senti! This is very good and exactly what I've been saying, though not with such succinct, technical terms. Excellent way for her to put it. I expect that will EXACTLY be the case. Though, as I said, I could be wrong. I think the administrative law process at the FDA will have to take normal, scientific rationality as a given, and what is in the best interests of the patients, given the disease, lack of progress in that disease and the seeming benefit.
I could be wrong, again, but I highly doubt this does not get approved, even if only for subsets of patients or only after some careful further efforts to address any remaining concerns regarding proof of anything that the FDA may want clarified further.