PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
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PharmaTher Holdings Ltd. has been granted a post-complete response letter clarification meeting with the FDA regarding their ketamine Abbreviated New Drug Application. This follows a complete response letter issued by the FDA in October 2024.
November 13, 2024 | 1:15 pm
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PharmaTher Holdings Ltd. has been granted a meeting with the FDA to clarify issues raised in a complete response letter for their ketamine drug application. This is a critical step in addressing regulatory concerns and potentially advancing the application process.
The meeting with the FDA is a necessary step for PharmaTher to address the issues raised in the complete response letter. While it does not guarantee approval, it is a positive move towards resolving regulatory concerns. The impact on the stock price is neutral in the short term as the outcome of the meeting is uncertain.
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