Biotech Values

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HIV co-infection part is recommended, while cirrhosis is strongly suggested, see the wording difference there, thus ABBV/ENTA to include cirrhosis in original NDA, but not HIV co-infection. But they did conduct the HIV co-infection trial per guidance. My point is they designed T1&2 trials for these two population specifically.

As of SVR12 vs SVR24, FDA had to give guidance to companies in EOP2 meeting regarding what should be primary endpoint for registration trials. Written guidance just follows what they guided before.