Cognition Therapeutics received minutes from the U.S. FDA, confirming that their proposed Phase 3 trial design supports the eventual NDA filing.
2 reports, 1 independent
Updated Aug 13
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New informationRepeats or wire copies
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What happened
Cognition Therapeutics received minutes from the U.S. FDA, confirming that their proposed Phase 3 trial design supports the eventual NDA filing.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA confirmed that Cognition Therapeutics' proposed Phase 3 design supports NDA filing.1 source
Zervimesine showed positive impact on cognitive scales and biomarkers in trials for neurodegenerative disorders.1 source
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The entities involved
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Cognition Therapeutics (United States)
company in Pittsburgh, United States
Nothing else this week.
- FDA
Related events
- FDA approval supports NDA submission in Aurora.
- Cognition Therapeutics, Inc. discussed registrational program key aspects with the FDA in May and received Notice of Allowance for a patent application on June 16.
- FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.
- A company is seeking definitive data for a pre-NDA meeting with the FDA in Raleigh.
Coverage
Newest first; wire copies grouped- GlobeNewswireCognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease - Cognition and FDA align on e
- GlobeNewswireCognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies and Alzheimer’s Disease - Zervimesine’s impact on debilitating