Replies to post #231004 on Anavex Life Sciences Corp (AVXL)

[frrol]

Great write up, some well framed questions. We might get some insights in an update, let's see.

The dosing change might be related to a possible washout period. It would baseline everyone, and the OLE data would then all start as Part B week 1 at MTD. Who knows.

[ElsaSara]

Great post!! In reference to my yesterday´s post.
I´m not going to argue with anyone..
Yesterday was talking about old people.
Free of charge is to visit the doctor/ hospital.. A few months ago I broke a muscle of my leg doing sport, I went to the hospital ,I just waited a few minutes.. and a few days later I had rehabilitation untill I recovered, and I paid 0 € .
I have to pay for drugs but some some people hasn't to pay for drugs, the majority of the old people has to pay a little amount 10% . maximun 8 €.
We pay with our taxes the health care system.
I read yesterday a post about socialism in Spain but it was deleted .. Spanish are terrible in many , many things , it is the sad reality, and now yes with a terrible socialist goverment + communist Spain is divided in two parts.
We don't learn ..we had a terrible crisis due to a pathetic socialist government a few years ago..and now again the same goverment.
Saludos from Spain!
Go Anavex!!

[anders2211]

To offer all participants of the study access a voluntary 48-week open-label extension, including microbiome assessment, was initiated and currently 100% of eligible participants have opted into the extension study.

The ALL participants part is important in that PR. So to give ALL participants a chance to participate Anavex started the OLE when ALL participants of the trial are ready, which was on the 17th. ALL participants can only mean after full enrollment and dozing...

So does the initiation of the PDD OLE signal the completion of the entire PDD P2 study?

I would definitely say yes...

PS Spain is the Florida for Europe to retire but 10x better ;)
May I suggest Tenerife :)

[Amatuer17]

Great write up and good questions - will you get answers to any soon - knowing M’s record unlikely. Most things are kept vague in his PR and leads to crazy speculations. He could learn from few CEOs

The other question is - if the patients need to come back after 1 year for extension, did the drug have any positive results that are noticeable?

[nidan7500]

Investor 2014, you are to be commended for this extraordinary value added accomplishment in dot connection. Time will tell, we assume. Along these lines, I have often thought that AVXL are dreaming if they think the patient/CNS clinical world will simply patiently wait (months/years) in their suffering after they become aware of any certain positive results from A2-73.

Sooner or later the news will get out. Then what will the tightly restricted, disciplined clinical world do?

[LakeshoreLeo1953]

Someone suggested the gap might have been filled by Compassionate Use of A2-73, but I very much doubt that as it would make the baseline for OLE patients quite a mess to establish. Aside from that how does the CRO and sites keep active hold of patients that finished a trial up to a year ago and then rally them all to opt in to the OLE just sometime before Dec 16th 2019?

I am in agreement with all of the above, however I draw the different conclusion.

Those feeling the "jungle network" of dosed vice placebo patients
encouraged one year gone participants maintaining 100% seems
optimistic.

How many one year patients transitioned to another trial
or otherwise no longer meet the exclusions if they were placebo arm
and still desperate let alone dosed and now one year washed out?

No matter the washout period it WILL differ from patient to patient under this assumption and cloud baselines.

The ONLY caveat to my conclusion is placebo arm when PDD complete transitioning to OLE active 2/73. That would imply confirmative data on efficacy which has not been reported nor led to the oft wished
TGA approval.

In the end.....uncertain, but inquiring minds would like to know.
Personal would wish the design allowed for seamless transition with the early 2019 approval.

I find THAT already available data intriguing and
certainly able to make soon "sooner".

[TempePhil]

Follow up to investor2014s good PDD summary.

A major question seems to be, what happens to the 'early' trial patients that completed the trial while others were still enrolling. These 'early' patients could have completed the trial as early a Jan.2019!
As usual we are looking to make sense of information, where there are many unknowns!

The blinded trial, when unblinded will provide data for High dose, Medium dose, and placebo. So what is really left to study?

I will look at some key phrases in the OLE descriptions:
RATIONALE:
We want to get more information about how ANAVEX2-73 might improve cognition in Parkinson’s disease with dementia.
You will receive ANAVEX2-73 if they participate in this study. The therapeutic dose will be a target of 50mg; however, the final dose will be determined based on the your tolerance. (Also, titration noted by F1ash!)

MAIN OBJECTIVE
Continue assessing the safety and tolerability

PRIMARY ENDPOINTS
Safety related

SECONDARY ENDPOINTS
Efficacy related

It looks like the OLE will add one more data point, maximum tolerated dose, and the associated efficacy for MTD. It appears that they will titrate up to determine MTD.

After OLE, there will be three points MTD, High dose, and Medium dose.

CONCLUSIONS
It appears that they have confidence in the High and Medium dose data, as they are not being pursued in the OLE!
It appears that the High and Medium doses are efficacious, as the trial is continuing to OLE!
The initial trial should have results by mid 2020, with the OLE following a reasonable course. Still cannot resolve the 'early' completing patients question, but maybe it does not matter.
Wow, strong signals from AZ, Rett, and apparently PDD.

Thanks to Investor2014, F1ash, Doc328 for contributions.

[Gernee20]

Great post. Thanks spaghetti monster for summarizing this up!

[jimmy_mcyoloswag]

Fantastic write up and excellent deductions! Thank you!