Replies to post #205620 on Anavex Life Sciences Corp (AVXL)

[ElsaSara]

I agree with your point regarding to the enrollment in PDd.
120 patients in Spain + ¿ X ? in Au , I think it is a real possibiliy.
On 19th March the investigator of Elche said that the enrollment would finish during May or June.
Besides two locations were added in Au on 1st May.
70% enrollment on 8th May.
Finally they are going to finish during Aug/ september...at least strange..
Saludos!

[XenaLives]

What if ???

What if the Alzheimer's trial is on the back burner?

Previous Alzheimer's trials have been large numbers of people and long duration.

If PDD and Rett are successful they are easier to approve on shorter duration trials. This will give justification for a shorter Alzheimer's trial and provisional approval for all three indications.

Just speculating that Missling might have a good reason to be tight lipped about all of this.

[Doc328]

I agree with almost your entire post. However, Missling completely blew his answer to a simple question (which should have been anticipated) with a rambling unintelligible response. He does not want to admit that the study is not even close to the timeline ESTABLISHED BY ANAVEX.

Like any other Biotech CEO Missling would like to beat the study completion estimate entered by the FDA.

The FDA/EMA/TGA etc do not establish timelines. He said "So the expected date is provided in ClinicalTrials.gov and I think that’s what you’re referring to. That’s all the estimate which, we don’t provide or confirm. It is point in time. But obviously, we want to finish a study as soon as possible." He is misleading, purposely. The responsible party to list and update the trial is the SPONSOR = Anavex. ANAVEX can delegate responsibility to the PI (MacFarlane) though that generally only happens in investigator initiated trials.

So, why is he not telling the truth. Either he is clueless which I doubt or he does not want to admit why Anavex is slow rolling the study. I hope he doesn't upset the FDA when he blames them for his errors.

From the clinical trials AD listing

Sponsor:
Anavex Life Sciences Corp.
Collaborator:
Anavex Australia Pty Ltd.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Also from the clinicaltrials site the definition of the responsible party

The statute defines the term as follows:
“(1) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation); or
(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.”

Later in the response, he says "It is point in time. But obviously, we want to finish a study as soon as possible. As I mentioned today in all our studies, they all are with the aim of before or done undertaking to finish it as soon as possible". ASAP, repeated twice in 2 sentences? He doesn't do the company or the stock any favors by saying silly things like this when the study is not recruiting to the timeline he established. It is amateurish.

He wraps up with "That’s also a question I would defer to once we are able to share the data with the FDA, with the agency and that determination is done by the agency. So it’s not something which we can anticipate at this point.". Consulting with the FDA is an important step after the Phase 2b/3 but they do not tell the company whether another study must be performed, but they will offer guidance to help the company decide. Companies are wise to consider all the FDA points from the meetings/communications. However, it will be up to Anavex, not the FDA, to decide to do another study and to figure out the details and timing of the additional study.