Mar. 14 at 9:34 AM
$CRVO Since the document was 147 pages long a short summary:
● Market still sees this as a dead “failed P2,” but the filing shows the setup improved
● Reached 2025 catalyst: FDA alignment done; Phase 3 in DLB planned 2H26, same CDR-SB endpoint, ~300 pts / 32 weeks
● Batch A underdosing issue identified; moving forward with stable crystal form + 50mg TID to match stronger Batch B exposure
● Same endpoint + fixed manufacturing + better patient selection + strongest prior signal = far more credible Phase 3 setup
● 2026 catalysts: Phase 3 DLB start (2H26), nfvPPA biomarker data (mid-2026), RESTORE stroke topline (2H26), ALS-Trials in UK
● Biggest risk = financing, not the science, not the IP
● Imho: Solving financing will start the push up, with or without dilution. Basically this will setup the Pre-Phase 3 squeeze until next catalysts
Earnings Call before market opens on Monday will pave the path. As long dilution is an option, bigger partner and buyers will poker for a discount here.