Really Col... You need to read the text a bit more carefully
“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs MAY support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-438
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