May I suggest the correct answer as regards the amount of time by which you should expect the minutes of an FDA pre-bla meeting is in fact 30 calendar days as per line 564 Section XI of the link provided below.
https://www.fda.gov/media/109951/download
I believe the last meeting took place approx 18 days ago so we will probably be updated by the end of next week at the latest.
Just remember that “Bell Potter” has already stated that the meeting was positive . If this indeed turns out to be the case, we may get definitive timelines for the first time for an “approval pathway” for end stage heart failure .At a previous analysts call, SI suggested we should expect the FDA would ask for a confirmatory trial ... (for which we already have an MOU in place with InCHOIR at the Icahn School of Medicine at Mount Sinai) . If we are granted priority review and accelerated approval, it would represent a very significant step forward for the Company.
I believe Mesoblast is currently half way through a major programme of establishing proprietary manufacturing protocols designed not just to drive down the COGS for larger volume therapies such as Revascor ,but also to prove batch consistency from multiple donors to a master cellbank for FDA requirements. A large proportion of this expenditure is exceptional as are the batch manufacturing runs for the existing bla application for Remestemcell. I also think that MSB is gearing up for full manufacturing capability within the next 12 months just as any confirmatory trial may have concluded.
It is my contention that investors in MSB do not fully appreciate the substantial IP involved in serum free production using 3D bio reactors .... i believe it is fundamental to the future success of the Company.
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