what we do know is the product is effective ... reason being is because its being used by TASLY pharma and they have increased payment in royalties to Mesoblast which shows its working
imo the CRL is just a TOOL so that the FDA can buy more time to process the BLA application of Mesoblast as it is the first of its kind so the FDA needs more time to process it along with hundreds of other applications its recieving from other companies
IRENE KRISTAL, I, Plaintiff, v. MESOBLAST LIMITED, SILVIU ITESCU, and JOSH MUNTNER, Defendants., page-167
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