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clock Created with Sketch. 06/04/25
20:38
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Originally posted by aquazul:
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As I have previously said, there is a huge unmet need for Diabetics and Ischemic’s with Inflammatory biomarkers in the CHF Indication. The company has previously received feedback from the FDA to focus on the patients at highest risk for death or other major adverse cardiac events (MACE). I believe the upcoming meeting with the FDA under the existing Regenerative Medicine Advanced Therapy (RMAT) designation shall discuss the potential marketing approval pathway for rexlemestrocel-L in high-risk patients with HFrEF (Heart failure with reduced ejection fraction) and recorded inflammation.
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See p.10 of this below FDA guidance for AA criteria for RMAT products ie. the top 2 bullet points on the page. Either one of 2 criteria needs to be satisfied. The second being reliance on multi-centre data. The completed randomised controlled Phase 3 DREAM trial on Revascor or Rexlemstrocel was based on 537 patients in over 50 centres. This is what @aquazul referred to in his post. The remaining bullet point on p.10 about choosing a surrogate endpoint that is agreed with the FDA is what the upcoming meeting about (plus CMC and manufacturing issues as foreshadowed in the company’s recent announcement).
(20min delay)