Jan. 14 at 3:54 PM
$CLNN In Sept 2024 FDA advised CLNN that its data was "not adequate" for an AA NDA but then changed course in Nov 2024 and explicitly laid out a path forward -- asking CLNN to generate additional NfL and biomarker data from EAPs and link biomarker change to survival. FDA only does this when gaps are fixable and CLNN then spent ~12–15 months doing exactly what FDA asked, with pre-specified analyses and independent datasets.
CLNN has now delivered reproducible NfL reductions across HEALEY + NIH-EAP, added GFAP + IGFBP7, and quantitatively linked modest NfL declines to lower mortality risk using large external ALS cohorts — precisely what FDA requested. Importantly, FDA already stated that whether NfL is a “reasonably likely surrogate” is a matter of review, not a pre-filing blocker. Historically, once FDA gives a roadmap and the sponsor executes, serial pre-NDA delays are uncommon. This setup is far closer to a “you may file, but with review-stage scrutiny” outcome than another stop sign
