Neurizon Therapeutics Limited (ASX: NUZ) Investigational New Drug Application Update
FDA Notification
Neurizon Therapeutics Limited (ASX: NUZ) has received notification from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for NUZ-001. The application is currently under clinical hold due to concerns about the sufficiency of information provided to assess the application.
Next Steps
The FDA communicated that further clarification and additional information are necessary to proceed. Detailed feedback from the FDA is expected within 30 days, and Neurizon is prepared to review this feedback thoroughly. The company aims to engage constructively with the FDA to address their concerns and advance the application promptly.
Executive Comments
Dr. Michael Thurn, Managing Director and Chief Executive Officer of Neurizon, acknowledged the unexpected nature of this development. He stated, “While this is an unexpected development, we understand that such steps can arise during regulatory review processes. We remain confident in the potential of NUZ-001 as a transformative therapy for Amyotrophic Lateral Sclerosis (ALS), and we look forward to working closely with the FDA to address their feedback.”
Commitment to Stakeholders
Neurizon continues to express confidence in NUZ-001’s potential as a safe and effective therapy for ALS. The company appreciates the support of its stakeholders and is committed to providing updates as they navigate this regulatory process.
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