Neurizon Therapeutics LimitedASX: NUZ

FDA Type C Feedback, HEALEY trial potentially registrational

· Issued by Neurizon Therapeutics Limited

Filed with ASX · · 2 pages · English

Summary by 6ix AI

The FDA noted that positive outcomes from the trial could support a New Drug Application, making it a potentially registrational study. Neurizon is focused on preparing the necessary evidence for the NDA submission, including biomarker data from the trial.

Written by 6ix AI from the company’s filing. How 6ix writes summaries

Release

Neurizon Therapeutics Limited ABN 35 094 006 023 www.neurizon.com Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222 FDA Type C Meeting affirms ongoing HEALEY ALS Platform Trial as potentially registrational ? US Food and Drug Administration (FDA) provides...

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