Neurotech International has been granted a pre-IND meeting by the US Food and Drug Administration (FDA) to discuss its NTI164 cannabis strain for children with Autism Spectrum Disorder (ASD).
At the meeting, set for March 15, the FDA will provide feedback on Neurotech’s chemistry/manufacture/control package, non-clinical requirements and the proposed developmental program for the drug.
The outcome is expected to inform the company’s planned future IND submission to undertake a clinical trial of NTI164 in the US.
Executive director Dr Thomas Duthy said: “We believe the controls we have put in place for drug product manufacture and the strong evidence of safety and efficacy we have demonstrated in our ASD patients, which now extends beyond 50 weeks of daily treatment with NTI164, will be important considerations for our upcoming meeting.”
In November 2022, Neurotech received Human Research Ethics Committee approval and TGA clearance to begin a Phase II/III clinical trial of NTI164, following breakthrough results from a Phase I/II trial conducted at the Monash Children’s Hospital in Melbourne.
Creso Pharma
Creso Pharma’s wholly-owned subsidiary Mernova Medicinal has bolstered its Canadian presence by expanding into Manitoba, driven by growing demand for its recreational cannabis products.
Manitoba – the sixth province in which Mernova now operates – has around 170 retail cannabis stores and Creso said the additional sales will help push the company towards profitability in 2023.
CEO and managing director William Lay added the “major milestone… broadens the group’s exposure for recreational cannabis sales to 60% of Canada’s provinces and will unlock another revenue-generating opportunity”.
Meanwhile, Mernova has also secured its largest-ever purchase order from the Nova Scotia Liquor Corporation (NSLC), worth A$350k and bringing confirmed orders for Q1 2023 to A$738k.
Earlier this month, Mernova announced plans to launch seven new products in Canada to be sold through the NSLC.
