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Re: sokol post# 398215

Saturday, 01/14/2023 10:45:06 AM

Saturday, January 14, 2023 10:45:06 AM

Post# of 473994
sokol

It will also be interesting to see how the EU regulators may react to Lecanemab given the failure of EU approval of Aduhelm. The EU said in its refusal to approve Adu, along with Adu’s side effects, noted this: “The European Medicines Agency noted that although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established.” See: https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-aduhelm-aducanumab_en.pdf



How many times does the Amyloid thesis (AD treatment) have to produce inconclusive or failed results before FDA declares it a missed approach and ultimately grounds the effort for good?
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