Moment of clarity for me.
Permission to refile the BLA
Data was for potency assay work
Primary endpoint was met in trial 001
Efficacy question was removed from the CRL
If potency work accepted then the 001 trial becomes an adequate and well controlled study
Accelerated approval is issued for serious unmet needs based on a surrogate endpoint.
But 001 hit its primary endpoint, so FULL APPROVAL in pediatric is now the likely outcome
With potentially an early stop in the adult trial due to overwhelming efficacy
My musings- just had to shake the AA out of my head
GLTALTH's
Reg
Moment of clarity for me.Permission to refile the BLA Data was...
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