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Side effects are manageable and well-characterized

Response: We encourage those entities that have made investments in clinical research to work with the FDA to determine if these studies are sufficient to support approval or clearance through the appropriate FDA regulatory pathway and to ensure that essential manufacturing information and controls are available to support approval of a PMA or BLA

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Even with a drug like a GLP-1 that is so high-value and seems to be very effective, we still have these non-adherence challenges. Another challenge is the shifting marketplace for these drugs, with new GLP-1s being developed and pricing shifts likely

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