sokol, hard to believe the BOD would be granting the equivalent of 2% of the common stock to TGD unless there were some known (to them) success with those in the trials, especially the Spain PDD.
Anavex is not allowed to PR much, but it wants the world to know how PROUD it is of the current status and the option route is the one way to do it ... hopefully, some other EE received options, too.
Anavex Now ,,, Mono-style ... and RWEm for Life!!!
“... screening and selecting the patients for the AD trial is critical.”
Very true, sokol.
However, it is not just for this one trial that set-up is crucial/critical for success. It has been the set-up of the entire way the phases are designed to play out that makes this a higher probability of success all around.
Remember the playbook:
It is better to design the overall process to fail quickly, as in the first or second phase, if likely to fail. Dr. Missling has said that you want to do everything correctly in the early phases (if the drug works; implied), to AVOID EVER failing in a phase 3.
Based on how this was designed and thought out from the initial phases (open, no placebo, small, tons of data gathering and dose ranges, and critical analyzing of everything from gut biome to genome sequencing on each patient with greater or less great response), the company has put itself into the position of an “academic” phase 3 in AD, and now with two additional indications following the same drill, all have much greater chance of demonstrating efficacy than of failing.
Dr. Missling has expressed the sentiment that ph 3 is not where drugs should fail. And yet, that’s where they all (most) do or have.
Now, all can discuss that this is why he deserves the options, why we will be a partner target, the timeframe, the SP, the charts...the sea bird, etc.
My proprietary AI software investment analysis program (patent pending) developed at Pittsburgh Supercomputing Center, over 2 years ago using Bridges HPC, designed to analyze all competitors in any sector across specified parameters, now gives AVXL a whopping 89% chance of approval for AD indication. In other word, SUCCESS. That’s compared against a 99.6% historic FAILURE rate in the AD space over the past 30 years. We jumped from 59% to 72% when Biogen caved. (When, not because. Was further evidence of wrong theory - Amyloid.) We jumped to 83% with ph2a extension data. (Because. Was further evidence of our MoA) Will update if/when numbers change - this was just a sample for today, fwiw.
Contrary to expectations (but not logic), with the announcement of enrollment numbers today...we go to 89%. Slow and steady appears to agree with the historical data significance for success. (Coupled with other parameters)
For those interested: NTRP is running second with a 54% chance of meeting its endpoints. (Disclaimer, this is based on a software program - designed to more accurately choose stocks for whatever purpose to enhance return on investment. I am trialing this now...my future fortune from AVXL gamble is being parlayed.)
Best of luck to all. We will not fail in phase 3. Upon approval, all those who frequent the MB are eligible for a free PC version of the program, in thanks for all the hard work, dedication, thoughts, and levity.
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