Ann: Neurizon updates on NUZ-001 IND Application, page-382

A response from MT on the investor hub to a question that someone submitted just yesterday. Sheds a bit more light on the current situation:


“Hi ND, I apologise if the shareholders are unclear about the nature of the FDA's request. As previously communicated to the market, the FDA requires additional exposure data (i.e., blood levels of NUZ-001 in rats and dogs) to ensure they have the necessary confidence that there will be no potential safety concerns for humans arising from the various toxicity studies conducted. We have been collaborating with Elanco and the FDA to establish the quickest path forward in providing this data. We have now submitted a request for advice to the FDA along with our proposed work plan to gather this information. Once we receive confirmation from the FDA that our proposed work plan is satisfactory, we will advise the market accordingly and outline a timeline for lifting the clinical hold. Please note there is no statutory timeline for the FDA to respond, but we are hopeful for a prompt reply given our recent interactions and the minor nature of our advice request.Regarding our position in the HEALEY Platform Trial, that hasn’t changed because we are confident, and so is HEALEY, about lifting the clinical hold soon. If anything, the delay has aligned our regimen more closely with upcoming additional regimens. This is a significant development for Neurizon as we need these extra regimens to run alongside ours to gain the maximum benefit (i.e. shared placebo) from the platform trial. Thanks for your question. MichaelPS. There is no real limitations as to how many regimens HEALEY can run concurrently. If the number is 4, they will run 4.”