Good thing FDA thinks this is addressing urgent healthcare needs, approval is now 6 months instead of 10 months, COVID 19 drug was approved in a month....Allows drug companies to submit parts of their application for approval as they become available, rather than waiting to submit the entire application at once, now eagerly waiting for next set of results, now every results will go to FDA for evaluation so in few months time FDA would have over whelming results to put a stamp of approval on this..
I see only one reason why precision did not apply for fast track on this, "Clinical Data Maturity" or may be " Specific Indication Focus" , if IMU is seeing this as part of ongoing clinical trail we have a winner..
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Ann: Azer-cel Granted FDA Fast Track Designation in Blood Cancer, page-98
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