This is obviously crazy good news, it seems clear that the FDA has stated that the data is sufficient for one trial. The question then becomes phase 4 trial post-marketing approval or just full approval.
This means we could have 3 commercial products next year:
- Remestemcel-L for GvHD: 6-month turnaround on a BLA resubmission pending OTAT response
- Remestemcel-L for Covid-19 ARDS: an EUA pending data that demonstrates the same trend in a phase 3 trial pending OTAT response
- Rexlemestrocel for CHF: Pathway pending FDA response
Still a few ??? about CLBP pathway - but everyone seems to agree it needs another trial.
Can someone please send me the screencap of the announcement that said that the FDA has already agreed with the potency assays for Rexlemestrocel? I know that they have said that but I can't find where.
Ann: Rexlemestrocel Greatest Benefit in Diabetics and Ischemics, page-28
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