Replies to post #344982 on Anavex Life Sciences Corp (AVXL)

[boi568]

Phil, nice catch:

"I don't want to go over the additional results of the PDD study, but we are moving forward with the discussion with the Parkinson foundations to design pivotal studies respectively for Parkinson now and Parkinson dementia . . . ."

Here is more evidence that Missling is playing an inside game with his data. He gets a lot of complaints here about missing deadlines, delayed analyses, etc., but also a lot of posts speculating that he is working behind the scenes with the FDA, etc. And both sides are right.

The reason is that Missling is first a scientist and researcher, and only secondarily a public spokesman. The two roles can conflict: He can emphasize the data analyses at the expense of the market/stockholder desire for information, or he can give interim public reports that may turn out to be incomplete or even partially wrong. Despite the potential for short-term benefits, that would be problematic legally, both with regulators and misled stockholders. I think MIssling is quite conscious of legal issues, given his traumatic experiences with shorts around 2015, but I also sense he would make the same choices even without the legal history.

We have an atypical CEO, and he is using atypical methods and and setting atypical goals. If he is right about the science, we will enjoy thoroughly atypical returns.

[abew4me]

Quote: "I dont want to go over the additional results of the PDD study, but we are moving forward with the discussion with the Parkinson foundations to design pivotal studies respectively for Parkinson now and Parkinson dementia separately obviously, because of the unmet needs for both indications, given the strong data."

TempePhil...This is huge because this sounds like TGD has been holding back with some of the data. (Which is contrary to what some of the posters here have been telling us)

Anyway, I think he'll (eventually) release the data at a more strategic place and time.

[tredenwater2]

Great recap Tempe. I listened to the conference call 2x and was astounded at how many new tea leaves there were from a rehashed presentation! By far tye best one yet and Im not a bit concerned a out where we are headed, especially with 5 years of cash runway in the bank. He is basically saying you guys better step up and bring your best and final offer because this negotiations stage is going to pass you by quickly on our way to profits!

Cheers!

Tred

[nidan7500]

Thank you Phil, this is exactly the kind of unfiltered factual comment we need.

Tidbit from JPM conference.
Dr.Missling gave maybe a couple nice tidbits.
He says he has the additional results of the PDD study. Also, and more importantly, he describes why the PDD trial data points to expectations of good results in the ALZ trial.

Here is the quote (my bolding):
Quote:
... Not only were the movement impairment features of Parkinsons improved, but also the cognitive features of these patients were all cognitively impaired in episodic memory, attention, language, visual spatial skills, and executive functions. There is a very precise tool called the CDR system, which is CDR Sum of the Boxes which often gets mixed up, the CDR system captures all these individual elements of cognition very nicely. And we found, on slide number 38, summarizes really nicely, a really close dose response, where the placebo arm declined, as you would expect in a degenerative disease, the medium dose stopped the decline, so it didnt change from baseline, and the high dose that actually improved on a net basis from baseline. So there is a clear shift in the pathology of cognition.

What is very neat about this episodic memory, quality of episodic memory, measure of this system, is that it has been published to correlate very highly with the ADAS-COG, and the ADAS-COG happens to be our primary endpoint in forthcoming Alz study. And what is also important is the Alz study uses the same dose regimen as this Parkinsons Disease Dementia study PDD. I dont want to go over the additional results of the PDD study, but we are moving forward with the discussion with the Parkinson foundations to design pivotal studies respectively for Parkinson now and Parkinson dementia separately obviously, because of the unmet needs for both indications, given the strong data.