Given the FDA Fast Track designation and the Day 7
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Posted On: 12/23/2024 7:12:26 PM
Given the FDA Fast Track designation and the Day 74 Letter due on December 23rd, it's possible that the review process could be expedited. If everything goes smoothly and TNX-102 SL meets all the necessary criteria, the approval could indeed come sooner than the projected date of August 15, 2025.
However, it's important to keep in mind that the FDA's priority is ensuring the safety and efficacy of the drug, so the process might still take some time. It's definitely an exciting development, and I hope it works out in favor of TNXP and its investors.
However, it's important to keep in mind that the FDA's priority is ensuring the safety and efficacy of the drug, so the process might still take some time. It's definitely an exciting development, and I hope it works out in favor of TNXP and its investors.
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