“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children, and the urgent unmet medical need.
A clinical benefit of Elevidys, including improved motor function, has not been established. As a condition of approval, the FDA is requiring the company to complete a clinical study to confirm the drug’s clinical benefit. The required study is designed to assess whether Elevidys improves physical function and mobility in ambulatory DMD patients with a confirmed mutation in the DMD gene”
i
Interesting also how much consideration and lee-way the new approach FDA has to NEW products. You missed that cherry picker. Funny that.
2023 The Final Countdown, page-711
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