The statement in the announcement about being advised not to do another trial until the assays were confirmed is interesting, it seems logical that the RCT wasn't completed with the BLA resubmission when you consider the advice from the FDA. The FDA would probably have rejected the trial data because at that point the assays work hadnt been completed. Perhaps there was something during the IND that changed the September 2020 CRL slightly. Without access to it, it's only speculation. What we do know is there is a phase 4 RCT starting soon. If 30 day survival rates is a condition of being eligible for enrolment to the trial, the data required can't be more than 30 days + 180 days from entry of the last patient. You would have to expect there are enough adults with aGVHD already that will meet the trial entry criteria, if 80% of the aGVHD patients in the US are adults. Filling the trial might be q quite a quick exercise. Like the shareprice action or not, the aGVHD story isn't over for Mesoblast. Financing is a discussion of course but if they can raise capital at these low shareprices then I dont see why they won't get to the finish line with the FDA. Only time will tell if they cross it.
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