$Tonix Pharmaceuticals (TNXP.US)$ Even though it's going to be until August, is there not a high probability of approval?

$Tonix Pharmaceuticals (TNXP.US)$
Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
Monday, 23rd December at 8:00 am
Tonix received FDA's Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025
TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA
Fibromyalgia affects more than 10 million adults in the U.S., who a...

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$Tonix Pharmaceuticals (TNXP.US)$
Brief Comparison with competitors:
While TNX-102 SL demonstrates significant and promising results, it does not outperform duloxetine (Cymbalta) in terms of pain reduction efficacy. However, TNX-102 SL has unique advantages, including its safety profile, tolerability, and potential benefits in addressing other symptoms like sleep disturbances. Tonix Pharmaceuticals' goal with TNX-102 SL is to reduce pain by improving sleep quality, which positions it as a differe...

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$Tonix Pharmaceuticals (TNXP.US)$ Waiting for takeoff