Yeah, 3 months ending in November means they start
Post# of 154090
(Total Views: 423)
Posted On: 09/17/2019 6:35:57 PM
Yeah, 3 months ending in November means they started right after the FDA meeting. That sounds like they were convinced the 525mg dose was the dose to the point they overlooked running the 700mg stability. Samsung has other mabs approved, so they would know this would be needed and would have thought to do it. We are privy to the fda communications over the summer, my guess was they were indicating 525mg would be the dose and surprised them yet again on Aug 28th. But yeah, someone should have thought to run the 700mg stability as a backup plan if the fda didn’t allow just 525mg.
It is crazy to me though, I understand them thinking 525 would be enough, 81% with 350mg in combo unmet need, that percent has gotten combo in naive population approved (at 48 weeks). Mono 525mg over 70% efficacy that we know of without the overlap added, which would beat some combo approvals in naive population. Yet 525mg + with optimized combo isn’t good enough with unmet need. It makes no sense. But it is what it is, see if they approved BTD and get the 700mg stability done if they don’t.
It is crazy to me though, I understand them thinking 525 would be enough, 81% with 350mg in combo unmet need, that percent has gotten combo in naive population approved (at 48 weeks). Mono 525mg over 70% efficacy that we know of without the overlap added, which would beat some combo approvals in naive population. Yet 525mg + with optimized combo isn’t good enough with unmet need. It makes no sense. But it is what it is, see if they approved BTD and get the 700mg stability done if they don’t.
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