jCyte, Inc. Announces Positive Pre-Phase 3 FDA Type B Meeting and Outlines Plans to Start Pivotal Trial of jCell® for Retinitis Pigmentosa in the Second Half of 2024
Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.
- Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.
- Sholar was also delighted with the FDA’s responses to jCyte’s description of its CMC program.
- “We are pleased with the Type B meeting minutes, which enable us to move forward with the US pivotal trial.
- The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection.