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biosectinvestor

10/29/21 10:33 AM

#413521 RE: Maverick0408 #413519

Hi Maverick. Won’t claim anything in the UK or EU. I think everything looks likely to go smoothly, assuming results match expectations. With the FDA, I think they’ve been likely in very direct and close discussions with all along. I do not think there is a battle coming with the FDA. And I don’t think more so than the others. I think the FDA will likely provide the pathway to expedited approval in most of the other jurisdictions. EMA is not yet signed up to Project Orbis, but maybe by then they will have some sort of collaborative relationship via Project Orbis with the FDA.
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hope4patients

10/29/21 10:36 AM

#413522 RE: Maverick0408 #413519

100% agree.