Outlook Therapeutics Says FDA Issued Complete Response Letter (CRL) For ONS-5010 BLA Based On CMC And Need For Further Confirmatory Clinical Evidence
Portfolio Pulse from Benzinga Newsdesk
Outlook Therapeutics has received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for ONS-5010. The FDA has requested further confirmatory clinical evidence and has raised concerns about Chemistry, Manufacturing, and Controls (CMC).
August 30, 2023 | 10:01 am
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The FDA's request for additional clinical evidence and concerns about CMC for ONS-5010 could delay its approval, potentially impacting Outlook Therapeutics' stock negatively in the short term.
The FDA's Complete Response Letter indicates that there are significant issues that need to be addressed before ONS-5010 can be approved. This could lead to delays in the approval process, which could negatively impact investor sentiment and the stock price in the short term.
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