Am I missing something? I don’t see anything in the PR about the pivotal mono trial. The FDA is allowing the company to use patients from the investigational mono trial (and others) who are on the 700mg dosage as safety data to submit a BLA for combo approval at 700mg instead of the original 350mg dosage.
I still take the FDA actions as positive and being favorable for the company, but there’s nothing I see that is specific to the mono pivotal trial.
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