Just so we're clear: Let's say, lower NfL is indeed a good thing for some drugs for #ALS, it's also good for #NurOwn right? @biospace @statnews #endals @FiercePharma @US_FDA #NurOwnworks ir.brainstorm-cell.com/2024-04-10-Bra…
@als_now @biospace @statnews @FiercePharma @US_FDA It is a nominal p-value. To claim NfL is lowered it also has to exceed assay variability of min 20% (EXPERTS ALS uses 30%) as well. This was covered already over years & it's the same data. Non sig trend. This isn't detracting NurOwn. Same for Clene etc. It just is what it is.
@VPResearch_ALS @biospace @statnews @FiercePharma @US_FDA 1/ Once again the misinformation comes from you. While it was a nominal p-value it was the analysis plan pre-submitted to @US_FDA, not post hoc. The data supported another trial- as the @US_FDA clearly agreed and WILL happen. Get used to it. And sadly, you misled people again..
2/ The document I posted cited the Phase 3 #NurOwn trial- thus it appears you "forgot" (or intentionally conflated) the fact it does NOT include the complete NFL and biomarker data from EAP, including pALS who got 6 (or 9) doses- which will be discussed on May 22. Or are you going to say now that you have a time machine?
@VPResearch_ALS @biospace @statnews @FiercePharma @US_FDA 3/ In my opinion your credibility regarding #ALS drugs isn't great. You supported a big #ALS sponsor's effort to seek approval of a weak #ALS drug approved only after two AdComs (then a truly grotesque price), based on what may be the biggest Type 1 pharma error ever...(cont'd)
@VPResearch_ALS @biospace @statnews @FiercePharma @US_FDA 4/ Notice the names on the paper, @VPResearch_ALS. Not exactly amateurs. And like you said: "It just is what it is". Centaur data showed increased NfL while #NurOwn shows lower NfL. Time to accept it and let patients have HOPE. This time there will be no massive Type 1 error....