News.... : ir.biohaven.com/news-releas... - Ataxia UK

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ir.biohaven.com/news-releas...

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Korkutalp
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wobblybee profile image
wobblybee

🙂 Unfortunately the first link failed to open but….I have already seen this online..

Re Troriluzole and Biohaven.

The company plans to ask the FDA for approval sometime between October and December. The drug has been granted a classification that could expedite the agency’s review process, and Biohaven estimates that it will be prepared to commercialize in the U.S. next year.

They have continued to study all SCA's with Troriluzole. They got FDA input on the study format. The current report is more focused on the slow-down in progression for all SCA's for those on drug vs. natural history. They will submit another New Drug App in 4Q 2024. Dr. Perlman feels the study results are very positive, and the FDA will not be able to ignore ... again.

sonofapeter profile image
sonofapeter

Thanks for this. Unfortunately, I don't have much faith that the FDA will approve it as this will be the second time around. All US institutions are corrupt and unless Biohaven greases the palms of the head of the FDA(this guy-en.wikipedia.org/wiki/Rober..., it won't probably get approved. I sincerely hope I'm wrong!!

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