MSB short selling data - 25th.Jan.2019, page-44

A couple of answers!

1. No - the FDA is agnostic on those issues - it is only required to consider safety and efficacy.
2. Maybe, maybe not, depending on what regulatory pathway MSB chose to adopt. But in any case irrelevant, I know of at least one case (in a very similar indication) where the dataset was agreed in writing upfront, and the FDA later decided to reject that dataset (note that the normal regulatory pathway would not involve this kind of upfront agreement in any case and as far as I'm aware MSB did not go down this pathway, so the control dataset is absolutely up for negotiation).
3. No, the FDA will act in accordance with its legislated responsibilities - if you believe otherwise you've never had dealings with the good folks in Maryland! And "fast" is not a word that comes to mind in my experience!

Changing the subject, I venture no opinion as to whether MSB has bottomed or not, frankly I do not know nor do I care! I like to deal in facts, not opinions!