StemSmart Eyes FDA Green Light for Crohn's | Sydney News

NeuroScientific Biopharmaceuticals is poised for a pivotal FDA meeting on August 31 to fast-track its StemSmart stem cell therapy for Crohn’s disease — aiming for Phase Two trials in the U.S. The Pre-IND session will scrutinize their science, trial design, and strategy for treating severe, treatment-resistant cases, with early data showing all five patients improved without serious side effects. This critical checkpoint could shape their path to approval in the massive U.S. market, as they target submission of their full IND application by year-end. Listen in comfort:Get a discount on a Soli Pillow: http://solipillow.com/discount/dnn. Advertise on DNN:[email protected] This is an automated, high-level news summary based on public reporting.Report issues to [email protected]. View sources & latest updates:https://sources.thednn.ai/59a70f57974328b2