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The F.D.A. can have a more flexible view of treatment efficacy without losing focus on safety . As with any drug, whether for migraines or asthma, there will be a spectrum of effectiveness.

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There is a spectrum of effectiveness but if it has little to no effect or significant safety issues the FDA should not be approving it. Thankfully the U.S. FDA did not approve thalidomide and shame on them for approving aduhelm. Where the FDA gets it wrong is actively sabotaging potential treatments.