Neurizon Therapeutics has provided an update on the NUZ-001 IND application, with the FDA placing the application on clinical hold pending further clarification and information. The FDA has outlined concerns about the sufficiency of information and potential risks to human subjects in the trial. Detailed feedback is expected in 30 days to progress the application. Despite this development, we remain confident in the potential of NUZ-001 as a therapy for ALS and are committed to addressing the FDA's concerns.
Dr. Michael Thurn, CEO, expressed optimism in working with the FDA to advance the program diligently and transparently. Neurizon is dedicated to advancing innovative treatments for ALS and other neurodegenerative diseases, with confidence in NUZ-001's potential. We appreciate the support of stakeholders throughout this regulatory process and are committed to providing updates as we progress. For more information, please reach out to Dr. Michael Thurn or Lidija Damjanovic. Visit our Investor Hub for any inquiries or to submit questions. We value your engagement and support in our mission to bring hope and innovative solutions to patients and families affected by neurodegenerative diseases.