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Posted On: 02/26/2025 8:54:37 PM
Post# of 150676
I must have been confused. Understood the HIV trial/BLA was dead, but thought all the cumulative data regarding safety will help us going forward (with this peer reviewed manuscript).
Are you saying they might be able to file the HIV BLA again?
Get the hold was for the ISS/saftey data, but does this mean we have a low hanging fruit of trying to file HIV BLA again (even though it's not an unmet need at this point)? Thought that data was toast and irretrievable due to Amarex?
I do know that the NASH trial data that started with Amarex, was attempted to be redone from the beginning and validated under their new CRO, at least in the 350mg open NASH trial.
Are you saying they might be able to file the HIV BLA again?
Get the hold was for the ISS/saftey data, but does this mean we have a low hanging fruit of trying to file HIV BLA again (even though it's not an unmet need at this point)? Thought that data was toast and irretrievable due to Amarex?
I do know that the NASH trial data that started with Amarex, was attempted to be redone from the beginning and validated under their new CRO, at least in the 350mg open NASH trial.
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