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marketing approval
$Tonix Pharmaceuticals (TNXP.US)$ approval rate of 80 to 90% in august, easily 20x
The probability of FDA approval for TNX-102 SL depends on several factors, including its performance in clinical trials, the quality of the submitted data, and the FDA’s review. Generally:
Approval Probabilities for Drugs at This Stage
• Drugs that have completed Phase 3 trials and submitted a New Drug Application (NDA) to the FDA have a historical approval rate of 80–90%.
• This high probability reflects the stringent testing required to reach the NDA stage, including safety, efficacy, and manufacturing quality data.
Factors Favoring Approval of TNX-102 SL
1. Unmet Medical Need:
• Fibromyalgia is a condition with limited effective treatments, and TNX-102 SL’s non-opioid mechanism addresses a critical gap in pain management.
2. Phase 3 Clinical Trial Success:
• The drug demonstrated significant reductions in fibromyalgia-related pain and improved sleep quality, with a favorable safety profile.
3. Non-Opioid Analgesic:
• TNX-102 SL aligns with FDA priorities to promote non-addictive alternatives to opioids for chronic pain.
4. FDA Acceptance of the NDA:
• The FDA’s acceptance of Tonix’s NDA signals that the agency found the submitted data complete enough to warrant a full review.
Remaining Risks
• Clinical Data Scrutiny:
• The FDA may identify concerns about the efficacy, safety, or quality of the drug during its review process.
• Post-Approval Commitments:
• The FDA could request additional studies or place restrictions on use.
Estimated Probability
Given the factors above, TNX-102 SL likely has an 85-90% chance of approval, consistent with historical trends for drugs at the NDA stage. However, the final decision will depend on the FDA’s detailed evaluation of the submitted data.
Approval Probabilities for Drugs at This Stage
• Drugs that have completed Phase 3 trials and submitted a New Drug Application (NDA) to the FDA have a historical approval rate of 80–90%.
• This high probability reflects the stringent testing required to reach the NDA stage, including safety, efficacy, and manufacturing quality data.
Factors Favoring Approval of TNX-102 SL
1. Unmet Medical Need:
• Fibromyalgia is a condition with limited effective treatments, and TNX-102 SL’s non-opioid mechanism addresses a critical gap in pain management.
2. Phase 3 Clinical Trial Success:
• The drug demonstrated significant reductions in fibromyalgia-related pain and improved sleep quality, with a favorable safety profile.
3. Non-Opioid Analgesic:
• TNX-102 SL aligns with FDA priorities to promote non-addictive alternatives to opioids for chronic pain.
4. FDA Acceptance of the NDA:
• The FDA’s acceptance of Tonix’s NDA signals that the agency found the submitted data complete enough to warrant a full review.
Remaining Risks
• Clinical Data Scrutiny:
• The FDA may identify concerns about the efficacy, safety, or quality of the drug during its review process.
• Post-Approval Commitments:
• The FDA could request additional studies or place restrictions on use.
Estimated Probability
Given the factors above, TNX-102 SL likely has an 85-90% chance of approval, consistent with historical trends for drugs at the NDA stage. However, the final decision will depend on the FDA’s detailed evaluation of the submitted data.
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你妈妈 : What is the concept of 20 times?
steady pp OP 你妈妈 : 5 billion market size for the drug, based on current market cap even if they capture 10% market share easily 20x from current price. please research more on your own
steady pp OP : it a high risk, high reward trade, if it does not get approve then it might drop alot
HailTheApocalypse steady pp OP : it's a
stock already so it wouldn't even matter if the price drops 
. no offense. I'm just saying.