If we assumed you are right, then the company and all on board are pretty stubborn and stupid to keep pushing the line when they know that the FDA will reject it and have wasted 2 years (approx) with the CRL - when they could have just take the CRL on the chin and conducted a small trial, to at least have made good progress on it
IMO...
No - I don't think you are right!
Mesoblast are not playing for chicken feed.
This is serious and company shaping event - Mesoblast cannot afford another CRL for Ryoncil - period!
The FDA should have told them that there's no pathway to approval apart from a trial - if they agreed with you.
But, they haven't. Instead Mesoblast had collegial conversations with OTAT (FDA) and have been guided to present Assays - which OTAT has deemed reasonable
Dr Krause - would not have joined Mesoblast and agreeing to the Ryoncil BLA resubmission - why should he ruin his reputation?
Finally, with the ambulance chasers around - there's no way Mesoblast would be playing with fire and deliberately go against the FDA
...
But, we are all guessing - so let's wait for the Ryoncil BLA Resubmission hey!
GL MSB'ers
MSB 2022 - The road to commercialisation, page-1338
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