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  4. CytoDyn Inc (CYDY) Message Board

ohm: I disagree with your interpretation that the

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Posted On: 08/12/2024 6:56:31 PM
Posted By: Jake2212
Re: ohm20 #145591
ohm: I disagree with your interpretation that the overturning of the Chevron doctrine by the Supreme Court would impact a FDA decision re approval of LL in a negative manner. This decision holds that a federal agency's interpretation of ambiguities or omissions in federal statutory language will no longer be accorded deference by a reviewing court. The decision makes clear that the agency's interpretation should be the starting point for the court's review and that the court should consider the strength of the record generated by the agency in support of its interpretation. Under that approach, the vast majority of agency decisions are likely to be affirmed if the agency has acted reasonably.

None of the above would come into play re a FDA licensing decision involving Leronlimab. Such a decision, whether to approve or deny, would not involve an ambiguity or omission in the federal statute that controls the FDA's authority. Moreover, I do not think any precedent exists by which a competing drug company has been granted standing to challenge an FDA approval of what would become a competing drug. On the other hand, CYDY would have standing to challenge a denial by the FDA, although the odds of success would be low unless the FDA clearly violated its own rules and regs or engaged in unreasonable or insupportable fact finding.


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