Thursday, May 19, 2022 11:11:11 AM
If the science is so derisked why don’t they start another confirmatory study right now with a new trial design? Doesn’t mean the drug can’t be approved with current study through AA. Why haven’t they received BT status already? They will have to run a PMR regardless. Nothing is derisked until we see the published data. Right now the board is still trying to come up with missing pieces in the data they’ve presented.
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