MSB will meet with the FDA this quarter, so in the next 5 weeks on pathway for Rex, which has orphan designation.
Best outcome would be that the FDA recommend AA pathway, which could lead to not only approval but the grant of a rare paediatric voucher.
that voucher could be worth US$50-$350m.
meeting on our BLA resubmission too this quarter… a couple of interesting FDA interactions, no market reaction to it just yet.
goodluck all… from a sleep deprived parent
Ann: FDA Grants Orphan Drug Designation for Revascor, page-215
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