About Biogen’s drug... “ The aducanumab tal
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Posted On: 02/06/2021 3:56:32 PM
About Biogen’s drug...
“ The aducanumab tale was already full of surprises, going from futility on its two Phase 3 trials to their resurrection (Mar 2019 news; Oct 2019 news; Dec 2019 conference news). Biogen submitted a licensing application to the FDA last year, and has also applied for marketing approval in Europe and Japan (Jul 2020 news; Aug 2020 news). The FDA application ran into headwinds at an advisory committee meeting, prompting speculation the application would be rejected (Nov 2020 news; Nov 2020 news)”
Source: https://www.alzforum.org/news/research-news/a...ree-months
They failed two phase three studies and the fda council recommended against approval, yet magically (lobbyists and relationships?) there seem to be people who think it will still get approved. We’ve seen before what cherry picking one small positive out of a big pile of useless will do when Remdesivir was approved and didn’t deserve it. It’s possible. But doctors will not hesitate to prescribe a better drug of it exists. Vyrologix would likely prove to be superior if tested, at least assuming their theory on why their drug is supposed to work is a valid one because we cross the blood brain barrier like a boss.
From everything I read about that drug it should not be approved.
“ The aducanumab tale was already full of surprises, going from futility on its two Phase 3 trials to their resurrection (Mar 2019 news; Oct 2019 news; Dec 2019 conference news). Biogen submitted a licensing application to the FDA last year, and has also applied for marketing approval in Europe and Japan (Jul 2020 news; Aug 2020 news). The FDA application ran into headwinds at an advisory committee meeting, prompting speculation the application would be rejected (Nov 2020 news; Nov 2020 news)”
Source: https://www.alzforum.org/news/research-news/a...ree-months
They failed two phase three studies and the fda council recommended against approval, yet magically (lobbyists and relationships?) there seem to be people who think it will still get approved. We’ve seen before what cherry picking one small positive out of a big pile of useless will do when Remdesivir was approved and didn’t deserve it. It’s possible. But doctors will not hesitate to prescribe a better drug of it exists. Vyrologix would likely prove to be superior if tested, at least assuming their theory on why their drug is supposed to work is a valid one because we cross the blood brain barrier like a boss.
From everything I read about that drug it should not be approved.
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