Ann: MSB Annual Financial Results and Operational Progress, page-188

  1. 13,244 Posts.
    lightbulb Created with Sketch. 3657
    Your timing logic makes sense.

    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 eek.png
 
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