These risks and uncertainties include among others results and timing of current and planned preclinical studies and clinical trials of valoctocogene roxaparvovec including the possible one year102023 651 PM BioMarin Receives Complete Response Letter CRL from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A  Au httpsinvestorsbiomarincom20200819BioMarinReceivesCompleteResponseLetterCRLfromFDAforValoctocogeneRoxaparvovecGeneTherapyforSe 56 extension of Study 270301 the content and timing of the expected follow up meeting with the FDA the content and timing of decisions by the FDA the European Commission and other regulatory authorities and those other risks detailed from time to time under the caption Risk Factors and elsewhere in BioMarins Securities and Exchange Commission SEC filings including BioMarins Quarterly Report on Form 10Q for the quarter ended June 30 2020 and future filings and reports by BioMarin