Brief: Biophytis Announces Next Regulatory Steps In Europe and U.S. For Cova Project

Biophytis SA

16/08/2023 06:11

Aug 16 (Reuters) - Biophytis SA  ALBPS.PA :
    * BIOPHYTIS ANNOUNCES NEXT REGULATORY STEPS IN EUROPEAND
UNITED
STATES FOR ITS COVA PROJECT
    * ANNOUNCED TODAY THAT IT HAS RECEIVED FEEDBACK FROM
EUROPEAN
MEDICINES AGENCY (EMA) AND FOOD AND DRUG ADMINISTRATION (FDA)
ENABLING IT TO PLAN NEXT REGULATORY STEPS FOR ITS COVA PROJECT
DEDICATED TO DEVELOPMENT OF SARCONEOS (BIO101) FOR SEVERE FORMS
OF COVID-19
    * BIOPHYTIS WILL ALSO PRESENT AGENCIES WITH POSSIBILITY OF
EXTENDING SCOPE OF ITS INDICATION TO VIRAL RESPIRATORY
PATHOLOGIES OTHER THAN COVID-19, NOTABLY INFLUENZA, BASED ON ITS
NON-SPECIFIC MECHANISM OF ACTION
    * PURPOSE OF THESE MEETINGS WILL BE TO GATHER
RECOMMENDATIONS FROM
EMA AND FDA TO FINE-TUNE COVA'S DEVELOPMENT PLAN PRIOR TO
MARKETING APPROVAL

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