Compiling cross-study safety event data for lifting the
Compiling cross-study safety event data for lifting the clinical hold is not nearly as heavy a lift as filing the BLA and I would say the optics of being “on hold” should be dispensed with as a matter of first priority given the clean safety profile of the drug; it may also be putting a break on other opportunities. That said, I think they are dual threading it to the extent possible. We don’t have any visibility on the challenges with filing the remaining clinical section of the BLA but I think might infer that the Amarex debacle might have left a wake for that effort.
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