(Total Views: 476)
Posted On: 09/02/2022 9:16:51 PM
Post# of 148903
Re: HouseofCards #128376
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.
(1)
(0)
Scroll down for more posts ▼