Have been following the arguments for and against 2 vs 6 months timeline following BLA resubmission.
IMO the answer lies in FDA's willingness (or un-willingness) to bring this much needed product to patients in need, more so than the dry texts called "guidelines". They are called guidelines, and are not legislation.
We should find out in short order.
Have been following the arguments for and against 2 vs 6 months...
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