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Message: Re: BOM 2 Trial

Jun 10, 2020 11:30AM
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Jun 10, 2020 11:38AM
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Jun 10, 2020 12:12PM

Thanks for the comments jupiter ... yes, a P4 would be awesome.

A ? for the more knowledgable science/study guys here? ... given the BTD status, and "working more closely with regulatory", even if another P3 (BoM2), does the BTD status enhance the ongoing study data visibility and ongoing review toward shutting it down early with confirming positive results potentially, possibly in favor of early NDA/approval? If results mimic or come within hand grenade range of BoM1 positive data/p values?

Wondering just how much the BTD itself, could come into play here, and as a strategic factor in determining the next type, length, commercialization benefit, and round of sudies?

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Jun 10, 2020 02:53PM
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Jun 10, 2020 04:07PM
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Jun 10, 2020 05:37PM
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Jun 10, 2020 05:59PM
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Jun 10, 2020 07:08PM
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Jun 10, 2020 07:34PM
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Jun 10, 2020 07:53PM
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Jun 11, 2020 01:15AM
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Jun 11, 2020 07:01AM
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Jun 11, 2020 09:29AM
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Jun 11, 2020 10:51AM
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Jun 11, 2020 10:54AM
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