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ADMA - ADMA Biologics Investors Prepare For RI-002 PDUFA
ADMA Biologics Inc
Back on December 19th, ADMA Biologics (ADMA) received a complete response letter "CRL" from the FDA concerning their PAS for BIVIGAM. The FDA had provided an improved compliance status at BIVIGAM's manufacturing facility back in September and had already delayed the PDUFA date in order to review the company's submitted package. Moreover, the company received a PAS approval for the drug product, but not for the drug substance. The CRL was a shock to the company and investors because most signs pointed towards approval. ADMA's CEO Grossman believes "the FDA ran out of