Remestemcel-L company forecast PDUFA is / was as far as we know still over the next 6 months. We were anticipating Dec 22 BLA lodgement, which looks like it has not materialised. So what could be occurring?
As @reg suggested, the company is most likely either waiting for FDA comment on the additions to the IND file, or there is a possibility they received something unfavourable back, and are acting prior to submission.
One analyst group was stating Q4 22 that BLA would be Jan 23, so there is also a chance this was the plan all along...although if it were, if PDUFA was 6 months the approval would be Q3 23 and not H1
2023 The Final Countdown, page-7
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