Can I get confirmation of the definite start of the 'clock' of the submission review period please?
It's upon acceptance yes?
So 23rd July.
2 months takes it to 23rd September.
So the window for approval / disaster is between September 24th and 23rd January 2025.
Based on previous examples, the FOMO period should start to ramp up (if there is one) mid October to mid November if the smarties on here are correct and we are looking at 3-4 months.
Could be a tough 7 weeks or so, but after that, I'd expect the SP to elevate in advance of the FDA decision.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-206
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