Replies to post #322575 on Anavex Life Sciences Corp (AVXL)

[RedShoulder]

It is possible for Anavex to make a similar presentation at the AAIC from an interim analysis of their OLE extension trial with at least 100 patients over a longer time frame of treatment,

That's a huge stretch, I don't think they would be allowed any kind of presentation this late, and Missling doing that by butting in would be out of character.

If he has anything new worthy of a PR (FDA or TGA) it will be the week after when the SAVA dust settles.

[Steady_T]

Reading the contradictory description on Clinicaltrials.gov it is hard to know what to believe about this trial and the interim look. The description says open label and then quadruple masking. Maybe it is masked only at the end of the 1 year open label period.

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately two hundred (200) patients will be enrolled into the study. All participants will receive open-label simufilam 100 mg b.i.d. for a year. At Month12, participants will be randomized (1:1) to continue taking simufilam 100 mg b.i.d. or to be switched to placebo for 6 months. At Month 18, all participants will enter a final 6-month treatment period of open-label simufilam 100 mg b.i.d.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching placebo for the 6-month randomized period (Month 12 to Month 18)
Primary Purpose: Treatment
Official Title: A 12-Month, Open-Label Safety Study of Simufilam Followed by a 6-Month Randomized Withdrawal and 6 Additional Months Open-Label in Mild-to-moderate Alzheimer's Disease Patients
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023

[Bourbon_on_my_cornflakes]

RIGHT, BUT WHERE IS IT? It is possible for Anavex to make a similar presentation at the AAIC from an interim analysis of their OLE extension trial with at least 100 patients over a longer time frame of treatment,

Are we scheduled? Will we drop a PR right before SAVA's presentation.

Time to turn the stealth fighter into a stealth bomber.

Been saying we could do this and/or take an interim peek at the Aus Alz results. Hoping Dr. M is considering it.