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Message: Re: BOM 2 Trial

Jun 10, 2020 11:30AM

Koo ... since it is a BoM2 trial rather than a bolt-on, assuming endpoints would be refocused to BoM1 positive results (with the high p values)??

... and hopefully with the FDA potentially granting early NDA/approval for critical unmet needs if the data is positive and "visible" to regulatory, as part of the BTD? ... is that a benefit of having a high profile BTD, and working more closely with the FDA and regulatory?

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