I know they have some of the top minds in the field all pow wowing on this. The tense part for me is will the FDA see that all parameters they require are met and they allow this trial to be used for approval if it is successful. I need to do some more DD on if there is record of the FDA allowing this and then granting approval for a drug after an EMA 2b trial. Gonna bury my nose in y computer for a bit.
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