Dec. 4 at 1:48 PM
$NRSN The skepticism regarding the Canadian NDS path is missing the bigger picture.
We must address the elephant in the room: The "Amylyx Trauma." Health Canada was burned after conditionally approving Relyvrio (Albrioza), only to see it fail and withdraw in 2024.
Consequently, the regulatory climate is hostile to new ALS drugs. In this environment, the default regulatory answer is a hard "No."
This is exactly why I’m doubling down on NRSN.
If PrimeC were just "another borderline drug," Health Canada would have killed it immediately to avoid repeating their mistake. Instead, we see the opposite: A regulatory "call back." The fact that Health Canada is engaging and aligning on a Pre-NDS meeting for April 2026 is a massive signal.
They don't waste resources post-Amylyx. This dialogue confirms they see the fundamental superiority in Phase 3 confirmation and biomarker data.
This isn't a rejection; it is a vetted roadmap to approval by a regulator looking for a winner.
Good luck!
