Unicycive has requested a Type A meeting with the FDA to discuss resolution of the CRL received in June in regard to its New Drug Application for OLC. Typically, Type A meetings are granted by the FDA within 30 days of the request. The Company plans to provide an investor update in the third quarter once it has received the FDA’s written feedback
Claim 70% Off TipRanks Premium
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on UNCY:
- Unicycive Therapeutics announces publication of OLC trial data
- Unicycive Regains Nasdaq Compliance After Stock Split
- Unicycive Therapeutics regains compliance with Nasdaq bid price requirement
- Unicycive Therapeutics approval delay ‘not a surprise,’ says Noble Capital
- Unicycive Receives FDA CRL for New Drug Application