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Posted On: 12/18/2023 8:08:17 PM
Post# of 154638
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Stealth Biotherapeutics, small company about to give up on an effective drug for an extremely rare syndrome, because the FDA has been so obstructive.
Stealth did not come close to meeting statistical significance in it's trial.
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The study did not meet its primary endpoints assessing changes in the 6MWT and PMMSA total fatigue score (TFS). Between the participants receiving elamipretide and those receiving placebo, the difference in the least squares mean (SE) from baseline to week 24 on distance walked on the 6MWT was −3.2 (95% CI −18.7 to 12.3; p = 0.69) meters, and on the PMMSA, the total fatigue score was −0.07 (95% CI −0.10 to 0.26; p = 0.37).
https://www.neurology.org/doi/10.1212/WNL.000...3D%200.37).
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