Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-206

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.