Anavex Life Sciences Corp (AVXL)

[Doc328]

It's wonderful news that we are starting yet another trial, but I think the market is dismissing this news because we have yet to fully enroll trials that have been started over a year ago.
Just an observation, but based upon the anemic SP appreciation of 3 cents on this news, it seems to be an accurate one.

It looks like all the action occurred on the 112 shares traded in premarket at 2.98

I wonder if he should have held the announcement until after the more anticipated PR for PDD full enrollment, though given today's anemic response I'm not sure that the PDD PR will do much. This is also sending huge mixed messages to investors. For several years, AD dominated the PRs and presentation. There's been a huge shift away from AD. If A273 works in AD, why aren't we trying to enroll the AD 2b/3 in a timely manner with more sites? Why hasn't the 2a clinical peer reviewed paper been published? His response to the AD enrollment question at the last CC was incomprehensible and also signaled the deemphasis of AD.

They announced the Rett study is initiated which means the protocol has HREC (AU version of IRB) authorization to proceed. Sites can't be initiated until the study is initiated. To get HREC/IRB approval, the sponsor needs a complete protocol and up to date investigators brochure as well as the plans for site selection and enrollment. I'm sure Kaufmann was busy with this over the last few months. Then the HREC/IRB takes a few weeks to review and sign off. So Anavex must have decided to do this study (prior to full results from the 2a's) before June. So this will take some more time and be a rolling process with some sites much quicker than others.

With so much focus on Rett and not expanding to enough sites for AD, does he feel that Rett has more chance than AD to succeed? One possibility is an orphan drug has an easier and usually quicker path through the regulatory agencies. They can also change more for the Orphan drug (possible a lot more like 60-100,000) than for an AD drug (maybe 6-8000/yr max), so maybe this route and AD deemphasis makes sense to MBA's. This will make less sense to AD caregivers. Motive doesn't matter much (as the SP today indicates). I think we won't see any significant movement in price until March 2020 when the topline PDD data is released.