Has MYOK indicated whether or not they'll need an outcomes trial eventually?
Not to my knowledge. I managed to find the information on the patient with the SAE. Apparently the patient was on beta blockers, which were not allowed in cohort A. While washing out the beta blockers, the patient started getting a-fib episodes. So not drug related. But since being off background medications is problematic in the real world, perhaps the really important positive result from cohort B is that the study drug appears to play well with them. The market seems to be seeing only the dose response issue at lower doses that I suspect is not really a problem, since the safety profile at higher doses seems fine.
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