Replies to post #252931 on Anavex Life Sciences Corp (AVXL)

[Biostockclub]

What does a comparison gain us (before we look for one)? Should understand our objective so as to prevent a “fool’s errand” use of time.

I’m of the opinion that whether other examples can be provided or not tells us nothing about which is the superior procedure. Follow?
We won’t know until the end - just as with other things.

We don’t know if A2-73 is a superior S1r agonist to already existing and approved ones, true?

We don’t know if S1r agonists will supplant other MoA’s already approved for AD or some which have not yet been approved - Bryostatin...

First, explain why or when or where (and how) it has been demonstrated that these restrictions for blinding have a deleterious effect on the outcome of the trial...then we can conjecture why our CEO has chosen to pursue an unusual path.

It could just as well turn out to be a superior path he has chosen - and we don’t have to prove that either.

Somethings you have to accept that this is, in fact, the path which is being taken and either accept or decline to support that with investment dollars. Freedom of choice.

If you feel that if something has never been done before this way, that makes it likely to fail, you should heed your risk radar and not invest or short the stock for a gain. But, we both know that’s not an airtight assumption and risk runs north/south and east/west.
Try to find an intersection where you are comfortable cause we don’t know if lack of prior history is going to turn out good or bad.

Maybe flip a coin? Or go with the old Clint Eastwood philosophy: Do you feel lucky?

Having examples and having no examples of this proves nothing, unless you can prove with certainty that there is a direct correlation to all companies with this behavior succeeding or failing and vice versa. Best of luck with that - impossible...but I’d love to see that presented!:)

[Doc328]

I had always assumed that 30 and 50 would be the doses for AD and PDD due to the desire to get above the 4 ng/ml threshold though was concerned about some subjects moving down from 30 and 50 mg to lower dose in the 2a due to tolerability.

It is possible that Biostock and F1ash are right and the 10 and 20 refer to the mg tablets and 30 and 50 mg to the doses. Yes, it is easy to mathematically combine 3 identical appearing pills to get 0, 30 and 50 mg and that allows the central AVXL storage to have fewer unique pills and allow for later possibility of titration. Pills are cheap to make (pennies/pill on top of the investigational drug cost and I don't think its any easier or cheaper to have multiple bottles with 10's and 20's vs fewer bottles with 0, 30 and 50. Additionally, this complicates the instructions for the patients and caregivers (who may be past prime or with poor eyesight). Which is easier and less prone to error: to tell an elderly couple to take 1 pill from one bottle or to take one from bottle A and two from bottle B --- especially when they will all look the same

During a study, patients are given bottles that are uniquely identified by code numbers. Patients likely have several visits over the first 3 months but then will have visits every 12 weeks for the second half of the study. Most studies I've been in with pills have bottles containing 30-35 pills (4 weeks plus a few extra since visit may not be exactly 4 weeks or 12 weeks away. So with A + 2B, patients may need to leave with 9 bottle instead of 3.

We will know in another 4-8 weeks. Since there are advantages and disadvantages to either combination (10/20 vs 30/50), its not a huge deal and I still don't get why Missling is being secretive with the dose. MacFarlane apparently told the Alfred reporter 30 and 50. Did he violate his NDA again? If Public relations/reporters who do not have non-disclosures know the dose, what possible reason is there to hide the dose from investors (especially those from 2014)?

Every study I've done has disclosed the correct doses being tested in the clinicaltrials.gov database so this is not typical. However, without wasting time looking at hundreds of studies, I can't say leaving the dose out is unique.

As another point, it is possible that there could be a titration to the ultimate 30 and 50 mg dose. One study I was in had a titration but the clinicaltrials.gov listing did not clearly state this. Protocols are 80-140 pages long so only the highlights are listed in the registry. That study had a tiny dose and the standard dose tablets and patients were given one bottle of small pills to increase from 1 to 4 pills daily over a set time and then subsequently were on one of two larger dose pills at the first follow up visits.