NUZ -- New Investor thread, page-1748

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illdrink2that

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23/06/25

10:43

Post #: 79528458
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Originally posted by NZ Trader: ↑

Surely NUZ could request a copy of the previous 5 companies accepted onto the Healey Platform and look for the comparative data they presented to have been granted an IND by the FDA?

What is hard to fathom is that NUZ have 39 months of Human Exposure Data that would exceed any K9 or Mouse six month exposure data????

Mind you in the NUZ company statement they stated Healey assisted with the IND Application?

17th January 2025 – Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the
Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative
diseases, has received notification from the U.S. Food and Drug Administration (FDA) that it has placed our
Investigational New Drug (IND) application for NUZ-001 under clinical hold, pending further clarification and
additional information. In their communication, the FDA outlined it has certain concerns about the sufficiency of
information to assess the application and any risks to human subjects of the trial and with the proposed dosing
regime.
The detailed FDA feedback is expected within 30 days and should provide the specific clarifications needed to progress
the IND application. We are committed to thoroughly reviewing this feedback upon receipt, taking all necessary
actions, and engaging in constructive dialogue with the FDA to address their feedback and provide the required
information so that the FDA provides clearance to the IND.
Dr. Michael Thurn, Managing Director and Chief Executive Officer of Neurizon, commented:
"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 and advance our
program with diligence and transparency. Our mission remains unchanged: to bring hope and innovative solutions to
patients and families affected by neurodegenerative diseases."
Neurizon remains steadfast in our mission to advance innovative treatments for ALS and other neurodegenerative
diseases. We have full confidence in NUZ-001's potential as a safe and effective therapy for patients with ALS and are
committed to addressing the FDA's concerns diligently and comprehensively.

Once that IND is granted watch the SP smash through 20c

Expand

So on hold since 17th Jan. Over six months.

Patients would have literally died while waiting for the FDA to decide IF giving them NUZ-001 MIGHT have exposed them to risk. Doesn't get much riskier than dying anyway.
Remembering that there is no effective alternative and that Healey trial patients will be constantly monitored (much more than patients on the current SOC). Any bad adverse effects would be picked up very quickly.

Last edited by illdrink2that: Yesterday, 10:44

NUZ Price at posting: 17.5¢ Sentiment: Buy Disclosure: Held
25 Upvote

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