Prime c shows statistically significant effect

[Buglaw]

Prime c posted top line results and it was statistically significant. I’m surprised given the size of the study. I thought it was next to impossible to have statistically significant effects in trials of this size Without a really drastic effect.

could someone who is more knowledgeable weigh in?

also, given the size of the trial I‘m having some doubts about approval based just off this. Thoughts?

NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial

A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP)...

neurosense.investorroom.com

 

[lgelb]

No, they will not get approval from a 2b study. They will wait for the NFL data, talk with Biogen, who has first-refusal rights and a much bigger checkbook to fund confirmatory trials, meet with the FDA, and then start planning in earnest the next trial(s) in 2H next year. I would hope to see P3 recruitment in 2025.

FRS-R, as a blunt instrument, can be easy or hard to show change in -- not a lot of nuance there and the lower the N, to your point, potentially less stability. But heterogeneity (this is a syndrome, not a disease) is a more serious problem statistically so if you get the right group through the luck of the draw, you do better with a small N but might not look so good with a bigger one, as we've seen before. FRS-R was a secondary endpoint; the safety and biomarker data do look promising so far.

Stay tuned.