Well, September is just around the corner, so we will see. I am not a voice specialist:))

Yesterday’s news was great step in the right direction. But PDD results are what the new longs are waiting and they will join when the results are revealed. Assuming the results are good:) Not sure why some people are not so patient. Nothing magic was going to happen today. But maybe by September

Best wishes and get well soon..

Today I talked to IR and I was told that Dr. Missling will give an update on enrollments/trial sites during the earnings call.. so hopefully, we will hear the updates..

Hmm, do you have a source for that?

I totally agree with this assessment. Sellers do not see an upside in the near term so they are putting their money into other undervalued assets that may give them a better short term return. Then they can get back to this stock. But the company is moving along with the trials, especially in Spain in terms of increasing the test sites etc. Rett trial is waiting for IRB protocols to be approved, so it may take a while, but that is the nature of this business. The company wants to get in a partnership with a better bargaining power which means no one will now come and offer the price they want. It is unfortunate but we are stuck in a waiting game. So as long as your investment can remain dormant for a while here, it is all right, until something comes up, which won’t be happening soon.

Well, it is all assumptions of course. But 20% success was fine because several years ago one analysis showed expected success for Rett trials is around 10-15%. Market is small enough to know its specifics and make correct assumptions. What changed is the success rate and synergy spill-over to other trials.. both pointing upward...

Noble research included Rett trial in their AVXL recommendation. Their assumptions were 30,000 patients in 2016; 20% success rate; peak sales of $500m in 2020/2025; remaining R&D expenses of $5m. Risk adjusted net PV was about 42m dollars. At that time the stock price was around $5 range. With their tech premium of 20% that puts the value at $50m. Now with FDA’s approval of IND, I would say the success rate is around 33%. I guess that would mean about $75m which is about $1.5-2 value increase. If the success of Rett trial improves the other trials’ success rate (it should imo), then we should add that synergy on. So I guess with the approval we should see about $5-7 range (currently the stock is oversold, should be around $3-4 range)m which is not great but still better than now...

If I remember correct from my discussion with the IR person, when a patient is enrolled, he/she starts to receive the dosage. Hope I am correct - would not want to misquote..

I talked to the IR about it and it seems they have gotten into back and forth with the FDA again and moving toward perfect design. Once again, it is all about one shot and get it done but I understand it has been too long of a waiting game.. hoping to hear from the company soon..

It is hard to satisfy this market, but you can’t start a trial without an approval, and the company has gotten two approvals and will start the trials. Once they begin, tutes will start buying. Rett is important, but it seems the company wants to get an approval with a single shot. This is actually good in the long run (hoping that science works). FDA’s continued back and forth makes me think they like what they have seen so far but are asking for a better design..

As my usual monthly call to Clint, I had a promising conversation with him today. We talked about Spanish and Australian test sites - the AD trial should start soon, PDD will follow that, I am guessing. It seems everything is going well. Then we talked about Rett trial, he stated that the company is still working with the FDA - now waiting to hear from them. The goal is to have a single shot trial which will lead to an approval. So good things take time, hopefully we will get that approval eventually.

We also talked about AF article - the company recognizes all those players in the market and their intentions (especially ones with inherent unhealthy skepticism), but is relentless in getting things done in a right way as soon as possible so that the science and shareholders are the ultimate winners.. I hope so too..

Cabal or not, this company needs to start the trials. At least the Rett trial should have been started.. how much back and forth will we be waiting for this trial to start??

“Good thing there wasn’t news released today. If so, then that would suggest there is a major leak from someone within the company and most likely bring an investigation”

This was exactly why I did not expect a new information. Next week will be the earliest, if anything, in my guess..

Is this profit taking behavior we are seeing today?

I know you have said that but I have not seen this change of procedure at FDA’s website and Clint did not say that specifically. I am sure there is a timeline that FDA has to respond each round and 30 days is the max for each round. So they can come back and approve right away but that does not mean that they cannot do it after 20 days...

It is back in FDA’s hands now. So even the company may not know what they will say. Once they get a green light they will announce, I am sure. Clint told me it can be next week or in a couple of weeks, so I am guessing we are back on 30 day clock again..

Thanks Bennyboy, yes the company is moving in the right direction albeit slower than I had expected. But here we are again going into a 5-6 month period full of potentially very promising news..

As my traditional monthly call to the IR, I talked to Clint today. He confirmed that the company is waiting to hear from FDA on Rett trial. It sounded like the time after they get the green light and before they start the trial will be rather short. Both will be announced when they occur. Also they are waiting to hear the approval from the EU authorities on PDD, but he said they are not doing it in Sweden, which was my assumption. He was positive about all three trials. I asked him about in which conference we will get an update about the AD trial, he did not say. But I guess we should get at least three year data some time during the Q3.

Thanks for adding more information about this. I still think he needs to communicate better and let us know where the Rett trial is right now. So I like his conservative approach with due diligence and running the operations/preparing trials, but not with communication..

Conference call that took place yesterday..

I liked this part of the conference call.

“we believe that the genomic data what we have seen and the data will be presented at scientific meeting is relevant for the compound -- in the interaction with the compound, and that means, if the impact on all future studies and that information will be applied -- the stratification will be able to applied in all future studies of ANAVEX2-73 and because of it is known that biomarker based on gene information has a significant advantage because it makes patient groups more homogeneous that also result in a higher chances of succeeding in clinical trials among other things being equal, and that's been provided in the literature very extensively. And so we are using really the same path of clinical study of [rigor] to applying to the CNS indications Rett Syndrome, Parkinson's with dementia and Alzheimer's disease, which so far has been only applied to oncology and that's also something which Anavex believes is at the forefront in that regard.”

Yes, that was my take, too. But I am cautious - things are not fully controlled by the company, so we need to allow for margin of error. But they are on the right track, biotech success takes time no matter what market thinks or wants..

You are welcome. I have always communicated my disappointment with the delay of the Rett trial. But I am positive on that the company is close to work it out with the FDA and possibly start late May or early June. I give the benefit of doubt to the management and hope for the best. Forget the market, focus on the company with all its rights and wrongs. Once a trial(s) starts we will see some action..

You can call and ask as always.. I am not sure, I did not get into details as I am less informed about the specifics of trial execution process..

My understanding is that FDA visits some of the sites, but not sure if before the trial starts..

Short squeeze is what I am hoping for too. But in the end if science works, we along with the patients will have a lot more important things to cheer about:)

Not sure, someone else may provide some insight on that. I assume the company sets some sites for trial monitoring..

I had a long conversation with Clint today. The company is visiting the trial sites for both PDD and Rett, so it sounds like we are getting close to starting the trials. Perhaps the lag between the approval of trial design and the start of trial will not be too long..

It says they had to do that study that is required by FDA. So they cannot go forward without that study. Clinical hold usually imposed when there is a risk to human subjects. So FDA may not officially IND on hold, but can require that test before the IND is approved.

What do we know about that toxicity study now? Has it been completed?

Jonjones posted about it after attending the annual meeting. He said juvenile toxicity study may need to be done per FDA’s request. Does it sound like a clinical hold?

That is what Clint told me - they are playing it safe and very conservative..

Thanks!

Thanks for info. Any specifics on why Rett IND is not approved by FDA?

It is possible, unless we hear otherwise. Clinical hold should have been disclosed though, IMO. Clinical holds generally have reasons, so they know what is wrong. I hope they give more details during the shareholder meeting..

They are more cautious about the timeline now, perhaps because of the last year’s flop on three trials. I am glad to hear an update on PD, but hoping to hear something about the AD, too.

The IR person made reference to 30 day rule several times in my conversations with him, so I believe that procedure applies to Rett trial here. The reason for delay is not the safety, but research design. I hope we hear more details tomorrow - unless their legal counsel disagrees...

I agree but I am not given an unusually optimistic forward looking statement by the IR person to be fooled. But I understand that the company cannot afford dealing with absurd lawsuits, hence if the IR person says the CEO must follow their legal counsel’s advice, I can only disagree and say updates on Rett trial should not cause such legal issues. But they are not going to listen to me, we have had lengthy discussions about what material information is and basically for every company it is what their legal counsel thinks it is, not shareholders.

On another note, this company is a micro-cap with not many stakeholders to talk to, so we need to talk to the management in every way we can to extract as much information (mosaic, albeit) as possible.

Thanks Nidan. I have had a couple of conversations with him along these lines, and all concur with what you have said. I also had a lengthy discussion with him about the silence and lack of transparency, and got the same response. I very much hope we can get more information about all the trials next week.

Hope we get some significant updates on Tuesday, this cannot drag on like this..

Yes, I have consistently asked for more communication and the IR person agreed but still stated that they cannot do beyond what the legal counsel advises. So instead of asking for more communication in this board, you can also pick up your phone, call the IR and express your frustration.