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A key milestone in this phase is the Day 74 Letter. It will happen in 2 weeks. The letter informs the sponsor of the application status and the next steps in the review process. We will see $1 again

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  • RocketRider : Tonix Pharmaceuticals submitted the New Drug Application (NDA) for TNX-102 SL to the U.S. Food and Drug Administration (FDA) in October 2024. 

    The FDA typically has a 60-day period to determine whether the submitted NDA is complete and accepted for review. 

    Therefore, Tonix Pharmaceuticals can expect to receive the FDA’s acceptance notification, commonly known as the “Day 74 Letter,” approximately 74 days after the NDA submission.

    Given the October 2024 submission, the anticipated timeline for receiving the Day 74 Letter would be in mid-December 2024.

    This letter will confirm whether the FDA has accepted the NDA for review and will outline the review schedule and any preliminary concerns.

  • 你妈妈 RocketRider : 有注明10月几号提交的吗?

  • RocketRider 你妈妈 : Not sure, someone say it was 16-Oct

  • 你妈妈 RocketRider : 谢谢回复