FDA Commissioner Dr. Marty Makary stood by his agency’s choice to reject a cancer treatment application from Replimune on Tuesday, as the pharmaceutical company’s stock price fell in response to the regulatory setback.
During a CNBC television interview, Makary pointed to the agency’s formal documentation explaining their reasoning. “If you read our what we call our complete response letter, you will see the details of the FDA logic,” the commissioner stated.
The rejection of Replimune’s advanced skin cancer therapy sent the company’s shares tumbling 5% during morning stock market activity on Tuesday.
