I will take this announcement with caution. FDA "may support " , and understanding the history between MSB and FDA, there is always divergence between will support and may support. Further studies, data, studies design and so on....We don't know the details and we don't have clarity what additional data may require. These announcements are good for the traders looking for quick profit however in long term this announcement will mean nothing unless approval is achieved and given agvhd regulatory approval delay, this won't be an easy path either.
Just be cautious about these announcements!!
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-28
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