Aug. 7 at 7:08 PM
$CRVO Strong bullish thought I caught with putting the UK timeline on neflamapimod in context:
📉 Dec'24 — RewinD-LB misses primary endpoint, stock gets hit (so it makes no sense to apply for UK or EU fast-tracks, as they often ask for early solid data beforehand)
🔬 2025 — new data, pill insights gained and development tells a different story: GFAP biomarker down, basal forebrain atrophy slowing, imaging showing real signal
🇺🇸 Nov'25 — FDA aligns with CervoMed on Phase 3 path for DLB
🇬🇧 Aug'26 — UK grants Innovation Passport (what non-europeans might not know: The bar for this got raised in 2025(!), so it's earned not given)
With no approved DLB treatments anywhere in the world, should EMA PRIME not be next? PRIME = EU's version of Breakthrough Therapy — early regulator hand-holding, faster review clock, and a real shot at EU market access years sooner than the normal path. No confirmation yet, but if the re-analyzed data cleared a tougher UK bar, why not PRIME next?
