Biophytis: Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19
Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.
- Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.
- Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients.
- According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe.
- We look forward to starting discussions with the FDA, and depending on feedback from this agency, we could consider filing an Emergency Use Application by the end of 2023 or in the first half of 2024."