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Nothing in this article constitutes a claim that any compounded product is clinically proven, has been evaluated in clinical trials, or produces the same results as any FDA-approved drug
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Lykos, which announced the CRL Friday evening, said it plans to request a meeting with the FDA to ask for reconsideration of the decision, and to get the agencys recommendations for a resubmission
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Although a substantial amount of knowledge has been generated regarding the mechanism of action of both drug classes, much remains to be understood
