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Matt, being a Brit, does not understand the weirdness of this Brand New Federal Holiday. Until this latest attempt to buy votes was formulated, Juneteenth was a local event in East Texas. Nobody else even knew what it was. The 3rd Obama Administration decided that it would be okay to print more money to pay people for another federal holiday, as long as it appeared to be nice to black people, because of White Nationalism and all that obviously Republican shit. By doing so, they hope to make everybody forget that the KKK was a Democrat Party organization. The audacity of these people is just amazing, and black people should be offended at being taken for such fools. Really, who here is falling back on the stereotype?Originally Posted by Jenni
Who in Idaho is responsible for this? The Californians?
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Meanwhile, Science Marches On: Top FDA official overrules staff to approve gene therapy that failed trial | Ars Technica
I wonder if Pete has a new house recently?The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own expert review teams and two of its directors.
In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.
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A joint review from the agency's Clinical and Clinical Pharmacology teams likewise concluded that the "totality of the data does not provide substantial evidence of effectiveness of Elevidys for treatment of ambulatory DMD patients of any age" and that the results "argue against" expanding access.
In a memo, Lola Fashoyin-Aje, Director of the Office of Clinical Evaluation in the Office of Therapeutic Products (OTP), and Dr. Nicole Verdun, Super Office Director of the OTP, concluded that the clinical results "cast significant uncertainty regarding the benefits of treatment of DMD with Elevidys." The two directors found the primary clinical trial endpoint results were "not statistically significant" and smaller analyses looking at secondary endpoints of specific patient measures—such as the time it takes patients to rise from the floor or walk 10 meters—were "inconclusive," in some cases "conflicting," and overall illustrated the "unreliability of exploratory analyses to support regulatory decision-making."
