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cowtown jay

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cowtown jay

Re: TankTheFrank post# 41280

Tuesday, 12/26/2023 1:07:51 PM

Tuesday, December 26, 2023 1:07:51 PM

Post# of 43443
I didn't know about Vanda suing for denial of fast track.

https://pink.citeline.com/PS146273/US-FDAs-Fast-Track-Designation-Policy-Faces-Unusual-Legal-Challenge#:~:text=Vanda%20Pharmaceuticals%20contends%20the%20agency,the%20designation%20and%20granted%20173.

Interesting case. I'm not sure how it may relate to us. In general, courts recognize the discretionary authority of agencies where it has been granted.

But, willful or criminal negligence is different, and an AG like Ken Paxton in Texas could look into this, if presented with solid reason as to why he should. I think we may have sufficient reason to investigate, if necessary.
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