Ann: Q&A on NTI164 Breakthrough Clinical Trial Results in ASD, page-3

22/07/22


expected ongoing news flow delivery points:
- re washout elimination and ongoing drug administration to the trial group - further safety and efficacy reporting on the trial
outcomes in Q4
- confirmed date and issued guidance with the initial FDA pre-IND meeting scheduled for Q3 2022 ( perhaps a reveal on who the US pre-IND consultancy group is)
- such guidance may well include accelerated approval registration from the FDA for the drug candidate aligned with the safety and efficacy reporting / program that is revealed with the ongoing drug administration to the ASD trial group
- Notification of registration of phase II/III drug trial received lodged in Q4 2022 ......to be undertaken Q3 2023
- Advice as it may arise during the next 2 yrs of any / all discussions and potential negotiations that involve licensing options of the drug candidate.
- Advice as to other indication investigations or intended studies for the development / administration of NTI164 for the host of 'neurological illnesses' it may potentially treat.
- Confirmation of the patent application for NTI being approved potentially Q1 2023 as per advice this release to market

well maintained development pathway and associated news flow should ensure healthy interest in th8is company globally for the ASD indication alone

glah