$Tonix Pharmaceuticals (TNXP.US)$ Wait after Oct30 $TNXP Key...
$Tonix Pharmaceuticals (TNXP.US)$ Wait after Oct30
$TNXP Key factors for approval
1. Positive Phase 3 Results: TNX-102 SL has demonstrated statistically significant improvements in pain and sleep quality for fibromyalgia patients in its Phase 3 trial, which is a strong indicator that the drug could meet FDA requirements .
2. Unmet Medical Need: Fibromyalgia has limited treatment options, and the fact that TNX-102 SL targets non-restorative sleep (a critical issue in fibromyalgia patients) could position it as a valuable new treatment in the market.
3. FDA Fast Track Designation: TNX-102 SL was granted Fast Track Designation by the FDA, which is a positive sign as it reflects the agency’s recognition of the drug’s potential to address an unmet medical need .
4. Historical Success Rates: Historically, drugs that pass Phase 3 and submit a New Drug Application (NDA) have a success rate of around 85-90% for approval. Tonix plans to submit its NDA for TNX-102 SL in Oct 2024, which boosts the drug’s chances of receiving approval.
1. Positive Phase 3 Results: TNX-102 SL has demonstrated statistically significant improvements in pain and sleep quality for fibromyalgia patients in its Phase 3 trial, which is a strong indicator that the drug could meet FDA requirements .
2. Unmet Medical Need: Fibromyalgia has limited treatment options, and the fact that TNX-102 SL targets non-restorative sleep (a critical issue in fibromyalgia patients) could position it as a valuable new treatment in the market.
3. FDA Fast Track Designation: TNX-102 SL was granted Fast Track Designation by the FDA, which is a positive sign as it reflects the agency’s recognition of the drug’s potential to address an unmet medical need .
4. Historical Success Rates: Historically, drugs that pass Phase 3 and submit a New Drug Application (NDA) have a success rate of around 85-90% for approval. Tonix plans to submit its NDA for TNX-102 SL in Oct 2024, which boosts the drug’s chances of receiving approval.
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ken_elt : Tonix has announced that they submitted the NDA on 16 October 2024. Under Fast Track, FDA will take 60 days to evaluate the submission for completeness. If accepted for submission, it will typically take 6 to 10 months for a decision by FDA under a Priority Review.
ken_elt : So, the important day to track is in mid December 2024 to know whether the NDA submission is accepted for the formal process of review to begin.