The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form102023 651 PM BioMarin Receives Complete Response Letter CRL from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A  Au httpsinvestorsbiomarincom20200819BioMarinReceivesCompleteResponseLetterCRLfromFDAforValoctocogeneRoxaparvovecGeneTherapyforSe 26Having previously agreed with the Agency on the extent of data necessary to support the BLA the FDA introduced a new recommendation for two years of data from the Companys ongoing 270301 study Phase 3 to provide substantial evidence of a durable effect using Annualized Bleeding Rate ABR as the primary endpoint