Upcoming catalysts from recent corp presentation:
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"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."
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IMO with the company NOT PR'ing the "filing" of the IND (as others here indicated was needed and therefore positively has not been done) I believe next PR will reveal that the Rett trial as been started, perhaps in the 10q.
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"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."
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With the company working on the ALZ trial design since ? early 2016 imo the Alzheimer trial was already MOSTLY designed. The delay imo was due to "enhancing" the trial design from Ariana's work, possibly a pre requisite of the 21rst CCA. Totally undestandable, navigating the IND for a never before designed Alz trial under the 21 CCA.
Dr. Missling and his team imo are/have been in a "fluid" trial design mode as more data continues to stream in. Precision baby, precision!
2018 is the year for "multiple trial readouts"!
Tred
