It's important to note that the trial discussed with the FDA, as most trials MSB does, failed to meet the primary endpoint (see below)
After, surprise, post hoc sub group analysis they found a couple significant findings.
The FDA may go along with AA - but there is no way they will approve based on a failed trial.
If MSB was smart they would be designing the next trial. I sure hope they are
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-98
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