My expectation is that since the primary end point of the trial failed to achieve statistical significance, once the application for acceerated approval is received then it will ultimately be rejected by te FDA. It would be a different story if the trial had been successful then the secondary endpoints would carry more weight. But sadly for investors, that isn't the case here.
And the FDA didn't say it "supports accelerated approval for Rexlemestrocel". It's wrong to suggest that in the headline.
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-440
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