LTB, I am also a long-term-believer. Locked and loaded and looking forward to 2018.
ANAVEX®2-73 Program Update:
The Company filed an IND for ANAVEX®2-73 in Rett syndrome, for which the Company received orphan drug designation by the FDA, and is expecting feedback from the FDA to finalize the clinical trial protocol for this study. As start-up activities with clinical trial sites have been underway, the Company anticipates dosing the first patient in due course following FDA approval of the IND. January in my opinion.
With the integration of genome sequencing information from ANAVEX®2-73-treated patients, the Company is now able to enhance the planned Alzheimer’s Phase 2/3 study. It is expected that incorporating this novel precision medicine approach as well as including comprehensive fluid-based biomarkers and multimodal neuroimaging, will enable a more robust regulatory submission, anticipated within the upcoming quarter. The randomized, double-blind, placebo-controlled study will be aimed at evaluating the safety, tolerability and efficacy of ANAVEX®2-73 in Alzheimer’s disease patients and will be conducted in both Australia and North America. Further details of the study will be shared in upcoming announcements. Q2 in my opinion.
Due the strength of the preclinical Parkinson’s disease data on ANAVEX®2-73 from a collaboration with Michael J. Fox Foundation, Anavex plans to file an upcoming clinical trial application (CTA) with European regulatory authorities to conduct a Phase 2 trial for ANAVEX®2-73 in Parkinson’s disease patients. Q2 in my opinion.
My opinion is a valid as that of many who predict nothing will happen in 2018. As an investor, I have to believe or I would have moved on.
Happy New Year to all who believe!
