Amylyx filing in Canada

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The trial showed delayed progression, which is not quite the same thing as improved survival. Remember, most people with ALS don't just suddenly die. Gradually their condition often goes to a point where continued survival isn't seen as the best thing. That's when people typically die.

So a trial that shows slower progression suggests that PALS who use the compound might take longer to reach that point, but it's also possible it might stop working as well or at all, that earlier cases might actually see less benefit, etc. We don't yet know those things. And the scale used to determine the progression rate (ALSFRS-R) is very flawed, so in longer use, AMX might do more or less than the trial suggested.

For now, we can say is that it did enough in terms of slowing progression for the Canadian authorities to allow Amylyx to submit an application for approval.
 
I buy my Tudca on Amazon and was fortunate to have a prescription for Sodium Phenybutyrate approved by my insurance Both mine are capsules and should be taken together. These are both the components in AMX35. I asked my Dr if I had an issue with the SP was it beneficial to take the Tudca alone he said absolutely. They are currently doing a study in EU for Tudca alone
 
Yup, thanks for linking the extension, Nikki. It's still a small sample size to conclude a survival benefit, let alone a dose-related one, so I'll stand on my caution with hopes that it's unfounded. Moreover, there is a considerable selection bias in PALS clinical trial recruitment because of center clusters, etc. But for sure, the extension's part of the reason that the package is getting an early look --a wise investment on their part.
 
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