Frankestin
2 weeks ago
We expect to submit the NDA for TNX-102 SL for fibromyalgia, a critical milestone for this program, in October of this year.
In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia.
https://www.morningstar.com/news/globe-newswire/9221333/tonix-pharmaceuticals-presented-data-and-analyses-of-tnx-102-sl-treatment-effects-on-fibromyalgia-at-the-2024-military-health-system-research-symposium-mhsrs
A p-value of 0.00005 (as in the case you mentioned for the drug) is extremely low, indicating a highly statistically significant result, meaning it is very unlikely that the results occurred by chance.
The p-value is crucial in scientific research because it helps assess the credibility of findings, though on its own, it doesn't prove the validity or effectiveness of a treatment.
WOW everything looks beautiful
BUT showed an analgesic effect size of 0.38 BELOW AVERAGE
if the effect is below average does it mean it is mediocre?
but perhaps it doesn't matter that the effect is low... perhaps it could still be an option that the FDA considers viable to provide a non-opioid option... maybe problem for sales
everything can be here but they will always screw to the retail. IMO It doesn't depend on the product but on what the retail does... handle with caution