Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)
The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA to discuss next steps for resubmission Sobi® (STO: SOBI) today announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company’s Biologics License Application (BLA) for NASP (nanoencapsulated sirolimus plus pegadricase) for the treatment of adult patients with uncontrolled
