It sounds like no dose trials on mice have commenced and that they are relying the extension trial results to convince the FDA that the drug is safe at higher doses. If the FDA knocks back their reasoning to lift the hold status, it would set them back at least 18 months, assuming they have the funds to commence the dosage trials on mice.
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- Ann: Safety Outcomes of Alzheimer's IMAGINE Extension Trial
Ann: Safety Outcomes of Alzheimer's IMAGINE Extension Trial, page-17
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