>>But you seem to be assuming there's a 100% probability and a timeline which is very short (you might be right) [Re: MNTA]
For some of us the time line has been a long one. I think it was 2004 when Jennifer Chao began coverage and issued a price target of 50.
It may very well be that we are near the finish line, but even if that proves true - it has been a long time coming.
It seems to me that MNTA would have been better off to just go the improvement route and do an NDA/BLA with trials. By now they could have had a product on the market.
MNTA is just one of many examples of a dysfunctional FDA.
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