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JohnJones325 shareholder meeting report...

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XenaLives Member Level  Wednesday, 04/18/18 10:07:28 AM
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Post # of 232688 
JohnJones325 shareholder meeting report...


Please note my previous sticky on Special Protocol Assessment can be found here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140087471

Quote:

Shareholding Meeting - Part 1

Overall great meeting. Missling graciously answered any and all questions that I had. And I had many. There were about 15 people there in total. I met Missling, Stephan Toutain, and Daniel Klamer. They were all very nice and seemed excited about the company and where it is heading. There were several other Anavex related people there including Clint from IR and a lawyer from K & L among others.

I arrived early and was able to get into a 20 minute discussion with Missling and 2 other investors from the Facebook group. Missling did a presentation with the usual slide deck and included a few new ones. After the presentation we were able to ask questions. I asked every question I could think of and they were all answered the best he could without giving away material information. After the meeting, I was able to meet with Christopher and a few other investors. We spoke about a variety of topics for about 20 minutes.

I’m not a science guy, so I will refer to others to clarify science related topics.

Rett
-Safety not an issue. In order to run the trial with these children, they had to do a Juvenile Toxicity Study required by the FDA. So NO issues there.

-Toutain said the trial would consist of 75 patients. During Missling’s presentation, he said it would be less than 100. So it sounds right.

-The specific patients in the trial are not selected yet. However, they have identified the patient pool from which the participants would be selected. Once the FDA gives the go ahead, screening will be done using the data collected.

-Delay is due to back and forth negotiations with the FDA. The 30 day clock seems more like a rolling clock, not set in stone. Because this is a new drug, using a unique trial design (especially for this indication), they want to do the most to get it done right. And also to get it done so it can be approved out of phase 2.

**All endpoints for all trials will be endpoints that were used in prior trials**. Meaning they are not creating new and improved endpoints.
-RWE will be used to determine effectiveness but will not be a primary endpoint. More likely a secondary peripheral measure and evidence of efficacy.

-There is a very low bar for Rett approval. Minor improvements will result in approval.

-Age range of children not determined yet.




https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140116501

Quote:

Shareholder Meeting – Part 2

Please note. I am only including facts and what he said. I will share my opinion later.

Alzheimer's

-The Alzheimer’s 2a trial was intentionally complicated to learn as much as possible.

-Sample size is more than sufficient and gives us the signal to move forward. He said that in some oncology studies, trials were planned using a signal in as few as THREE patients, which eventually led to approval. So, in comparison, we have more than enough and the signal we have is strong.

-Safety was emphasized. Since the MTD was shown to have some adverse effects, they will use a lower dose. Smart.

-Extension for our current patients will be forth coming if they opt to continue.

-He acknowledged the fact that MMSE and ADL are not precise measures due to their somewhat subjective nature but it does give us a signal that something is happening.

-Genomic signature found and to be reported at an upcoming conference. The signature allows them to accurately predict who will benefit most from 2-73. This way the data can be used in all future trials.

-Missling believes that our drug would have been proven to work regardless of which type of trial is done. Even if we didn’t have the Ariana or Illumina data. Now that we have it, it gives us an even bigger advantage and significantly increases our chances of success.

-Illumina was not in the plan all along. After he saw the failures that were occurring last fall, he decided to take a step back because he did not want to go down the same road. Hence the delay and hiring of Illumina.

-He said the delay and the hiring of Illumina was a wise decision and he was very confident in the signature(s) that was/were found.

-Alz IND still on track to be submitted this year.

-They will NOT wait for the Rett read-out before starting the Alzheimer’s trial. There’s no need to. They are completely different indications and the info learned will not really effect the Alzheimer’s study. They are completely independent.

-He was not sure as to the main reasons why our Sigma 1 agonist is superior to the others out there. He said the muscarinic may have something to do with it. He also said there is a difference between Sigma 1 activity and Sigma 1 activation. We have activation and the others have activity.



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140117066



Quote:

Shareholder Meeting – Part 3

Parkinson’s

-The move to Europe was because of many factors. Cost, availability, LUND, etc..

-LUND will not be conducting the trial. They are PHDs not MDs. MDs will be needed.

-MJF gave us 300K for the preclinical

-Targeting more cognitive improvements as opposed to physical.

-It will not be an expensive trial


Funding

-28 million – plenty to do all trials
-They will look for other funding opportunities
-He expects more funding from the Australian government


IP

-They have many patents already and many have been filed or are being filed.
-Compositional Matter
-Crystallization of compound
-Method of use for all indications
-Processing and Manufacturing


Miscellaneous

-Biogen MTA – Long shot, too early. Next step is to do a model study. Missling said they have enough on their plate already.

-Organizations that have done testing – Angelman, Fragile X, etc. were excited and said it was the strongest signal they have ever seen. Missling offers these companies/organizations the opportunity to do testing on their dime. Some accept and some don’t.

-He did not rule out anything – partnerships, buyouts, etc. He said he will take things and evaluate them if and when they come.

-**He said he will be “loading up” again shortly. “Why wouldn’t you at these prices”. He couldn’t buy more because of the shareholder’s meeting but will.

-He said they already have some protection from a takeover and really did not feel the need to go for the blank check preferreds again. Maybe next year.

-They have a good relationship with the FDA

-He said that when people look back and see what we did and why, they will understand

-Distribution and manufacturing – early stages of planning and discussion.


Final Thoughts Coming. Maybe not tonight though.



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140117520

Quote:

Shareholder Meeting - Additional thoughts and opinions.

Overall Missling exuded confidence. He spoke passionately about our prospects and it was genuine. Despite having presented the same thing countless times, his excitement for our data rubbed off on me.

It was encouraging to hear him want to buy more shares. He spoke like it was a gift at these levels.

It was comforting to hear him speak of failures and how we are not like them. He even referenced Axovant pumping their drug and how he didn’t want to be like them.

He agreed and knew that people were skeptical because most still think you need a study with thousands of patients. And you don’t.

He talked about feeling a sense of relief or a renewed confidence when the Illumina data was revealed. (My paraphrase)

In a way I understood the silence. Really. What was he going to say? I screwed up with the timelines. I underestimated the difficulty in planning these trials. Not what people want to hear and it’s not what a leader wants to admit. Saying this would’ve hit the sp just as hard and probably would have had us demanding his head on a platter even sooner.

He was still amazed with the fact that we show signals across so many indications. It really tells us that our drug does something. He also stated how he believed that using our own bodies to heal itself seemed like the best way.

He is juggling a lot and is dynamic in his approach like all CEOs should be. When new info comes along he acts and make changes based on it. That’s why strict timelines are so difficult to keep. Still a mistake on his part.

He put to rest some areas of contention, in particular the power of our small sample size and the safety of our drug in pediatric patients which renewed my confidence. Hearing it from the horses mouth in person is different than listening to a canned presentation or reading it on some slides.

I walked away feeling there is a bright future ahead of us. I also understand that this will take more time than many of us expected. However, they are marching forward with their eyes on the prize.

Like many here, I anxiously awaited news thinking something big was about to happen any minute. Still could but the anxiously waiting has turned more into patiently waiting. These few years have tested our patience to great lengths. News will come when they are ready. He doesn’t want to look back and say. We should have, could have but didn’t.




https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140121153





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