Neurotech International Limited announced the US Food and Drug Administration (FDA) has approved the Company's request for a pre-Investigational New Drug Application (pre-IND) Type B meeting to be held on 15 March 2023 (US time). The purpose of the meeting is to seek FDA feedback in relation to the Company's chemistry/manufacture/control (CMC) package, along with non-clinical requirements and the proposed clinical developmental program for NTI164 in Autism Spectrum Disorder (ASD). The outcome of the meeting is expected to better inform the Company's planned future IND submission to undertake a clinical trial of NTI164 in the US.
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Jul. 10 | Neurotech International Validates Efficacy of Cannabis Therapy in Autism Trial; Shares Rise 3% | MT |
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