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# Seneca Gets FDA Guidance on Phase 3 Trial
- URL: https://www.fdaweb.com/seneca-gets-fda-guidance-on-phase-3-trial/
- Published: 2020-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:10:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146539

Seneca Biopharma says that discussion and feedback during a 3/10 meeting with the FDA Office of Tissues and Advanced Therapies led the company to believe that the Phase 1 and 2 trial results of its NSI-566 neural stem therapy candidate to treat patients with amyotrophic lateral sclerosis (ALS) support moving into a Phase 3 clinical study. “We received significant guidance from FDA regarding an acceptable trial design and are in the process of developing the protocol for further review,” Seneca chief medical officer **David Recker** [said](https://www.heraldmailmedia.com/news/state/seneca-biopharma-announces-results-of-meeting-with-fda-regarding-the-design-of-phase-3-trial/article%5F4a477642-0a18-53a8-a2d2-80b5b57462cd.html?ref=fdaweb.com).

The company says that FDA has granted NSI-566 orphan drug designation for treating ALS.