Great news...
Confirmation That BLA is targeted to submit within 5 weeks, and that CLBP trial design should also be submitted within 5 weeks.
CLBP USA trial to start Q2 23.
CHF RMAT meeting Q1 23 estimated ( awaiting FDA to confirm the dates )
I want to know - can the company request the investigator crohns control arm results !
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-33
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