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Openai/695d19fd-1f5c-8003-8f33-753ff9f833ab
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==== 6. Safety comments are narrow and carefully framed ==== The release highlights: * Oral dosing convenience * Lack of ARIA * No “significant safety concerns so far” What’s missing: * Any FDA statement that safety is sufficient for approval * Any mention of long-term risk assessment * Any statement tying safety to benefit-risk adequacy This suggests safety is not the main barrier, but it is not yet resolved either.
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