Manufacturing was always a concern for me - but, I've casted it aside. Looking back, given that the FDA raised manufacturing concern for a niche market (Ryoncil GVHD); How can they not be concerned about a mass market product (RemL for C19 ARDS). However, the previous go ahead of the NIH sponsored C19 ARDS had clouded my thinking.
BTW - Do you mind giving a quick rundown on what an OTAT process would entail? e.g. Is it a public hearing?
I'm learning so many things on the Mesoblast journey: BLA, rolling reviews, priority review, accelerated approval, EUA, ODAC etc It just like the Olympics, the best people to run this Olympic is the last group that organised it
MSB Price at posting:
$1.62 Sentiment: Buy Disclosure: Held
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