Synaptogenix Inc (SNPX)

[dia76ca]

I will grant you that AVXL are very inconsistent regarding what they announce. Management has not stated that they will have any Parkinson results by mid year....however they now have 16 of 19 centers enrolling patients in Spain and government documents which stated that the trial duration is "5 months". Enrollments began by November 1 ...5 months duration ends around March 31. Even with some delays we should expect some top-line data anywhere from the middle of April to the end of May.

Here is what they have said publicly about Rett.
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Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Company has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug application (IND) is NOW OPEN for ANAVEX®2-73 for the treatment of Rett syndrome, a rare and catastrophic neurodevelopmental disease.

ANAVEX®2-73 has already received orphan drug designation from the FDA for the treatment of Rett syndrome.
“The acceptance of this IND by the FDA is a significant milestone for ANAVEX®2-73,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This is an important step toward achieving clinical data for the third indication for ANAVEX®2-73 also incorporating genomic precision medicine biomarkers.”
FDA has allowed Anavex to proceed with the Phase 2 study protocol, ANAVEX2-73-RS-001, A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients with Rett Syndrome using experimental drug ANAVEX®2-73 for the treatment of patients with Rett syndrome. The Phase 2 study is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Pharmacokinetic and dose finding will be investigated in a total of 15 patients over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study will be followed by a planned placebo-controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3 month treatment period.
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What is "now open"? That is language usually used for enrollment. Note that this is a randomized double blind, placebo controlled study. While it is a Phase 2 study it clearly is in two parts. The first part is described as follows...

"Pharmacokinetic and dose finding will be investigated in a total of 15 patients over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers."

This part appears to be open label and it is these results which should be gathered rather quickly as there are only 15 patients over a 7 week treatment period. I would expect these results will be announced before mid-year. The second phase of the study(randomized, double blinded, placebo controlled etc.) will follow on over a 3 month period. So the results for the entire trial will be available later in the year. The important take away is that this is US FDA approved...for those who like to pretend that Australia or Spain have lower standards...this is news.