Falconer, I've always appreciated your thoughts. Is it possible that with the different indications that Anavex is pursuing, that Dr M may ask for FDA approval for GABA and glutamate normalization, rather than a specific indication. That way if a person has a CNS disease with this problem, a doctor could prescribe it. There could be a so called list of diseases, that even though it had not been involved in a trial for your indication, blarcamesine would be an approved drug.
I know that this would be an entirely new approach, but the FDA needs to up it's game when it comes to Anavex. With the MOA that blarcamesine has, there has been nothing before that can compare. Your thoughts?

Yes finally the words "met primary and secondary endpoints". I am surprised and happy that the results came within this quarter, and were so definitive. What would you like to see as an amendment to the PDD results that we have seen so far. Do you think positive actigraphy readouts would provide clarity. I have been very disappointed until now with the information provided by Anavex, but hopefully with this, there is a much clearer path to approval.

Yes! Very exciting in both results and time of release. I truly did not believe we would hear about this until next year. If quarterly pr or CC would give some clarity to PDD, perhaps actigraphy readouts, this would be a great Christmas.

How will vaccines affect leronlimab? I personally think that we will need leronlimab for covid-19 for years to come. I don't think the "herd immunity" will be forthcoming as readily as many think. I don't see it for the common cold, which this is part of the family of, or even the flu, which we need to get yearly shots. I sincerely feel that even after vaccines have been in place for a year or more, individuals will contract covid-19 due to the vaccine needing to be re-administered at least yearly, or perhaps even sooner, as well as individuals just not taking it. People get the common cold often, and take medicine for the symptoms and deal with it. I think that there will be a need for leronlimab to treat covid-19 for quite a while.

Will CYDY take Dr BP up on his offer? What do you think might give NP pause on going this route?

If cydy can get approval for HIV next year, I think that's all we would need for $20 sp. Anything from covid would be gravy. Possible cancer indications as well as nash make next couple years exciting.

I would sh#%*t my pants of we could get to $20 by end of next year.

NP mentioned he expected revenue next year to be 5 to 10 billion. How many think it could be close to that and what would it mean to sp?

I heard receptor occupancy was the reason as well for delay from FDA on HIV BLA during CC. Does anyone here have an idea how long it might take to resolve this. All I heard were phrases like "soon" and "as fast as possible". I believe we will see revenue in 2021, just wondering how much because of having to run such a daunting obstacle course. Is it possible that a BLA could be submitted to MHRA or Canada, before one is cleared with FDA?

I listened to the call and I feel that the chance for revenue in 2021 is very high. Going to be a good year neXT year.

I listened to the call and I feel that the chance for revenue in 2021 is very high. Going to be a good year neXT year.

What was responding to said "data" not approval. If there is "approval" then there will be revenue. I don't believe we see approval until 2023 after pediatric Rett trial as long as it's very good. Avatar Rett trial I don't believe will get Anavex any "approval".

Institutional participation will be slow to begin with due to the uncertainity of MOA. What Anavex is doing hasen't been done before, and wall street wants clear direction. Other companies have applications or drugs that tackle known quanties with novel tactics, and if proven successful, are rewarded. Anavex is trying to tackle unknown's (is it Retts, PDD or AD or what) with unproven MOA, so I believe there will be a big wait and see from wall street.

Even if there are results that are worthy of regulatory consideration, you won't need a "porta potty" because sp will still go down. Only when revenue is actually realised will sp slowly appreciate as institutions buy in and you will see that coming a long way off.

You will get a very non specific answer. Lot's of "soon, high expectations, encouraging data" but ir will not be straight with their answer.

I am hoping we get a pr before the CC that says a BLA or BLA's have been filed and that DSMC has agreed to 28 day review which would put it before Christmas. That would be a great pr!

Just like Missling said "PDD by Sept 30", no doubt just as reliable.

That's why I support a buyout! Management at Anavex is horrible and inhibiting potential life changing drug to get to those who need it because of their incompetence. A fair price I feel would be 3-5 billion and let a big bio with resources do the trials and they can get it approved in a timely manner. Shareholders would be rewarded and patients would receive needed treatment.

So you're saying that it was met and Dr M failed to disclose this because he wanted the complete picture when he revealed PDD data? That is crazy because he should know that what is happening to sp would happen should he not reveal that they had met primary endpoint. He may have more data, but bottom line the primary endpoint was not met according to predetermined targets or we would already know.

By not saying they met it, means they did not. If they had, it would have been announced, that you can count on.

Not meeting primary endpoints is negative news!

Yes we have lived with "soon and imminent" for far too long. If Dr M would only realize what his misleading statements do to share holder confidence he would stop. Making statements such as "by end of September, you can count on it" and then still not complete data released coming up on Dec CC, it is a tragedy. I feel that in the best interest of everyone concerned, those that would benefit from 2-73 for their health, as well as shareholders of Anavex, a buyout would be best. A large pharma with the resources to get the drug to the people who need it in an expeditious fashion, as well as individuals who own shares would see some return on their investments. I think any amount over 3 billion would be great!

What I think is irrelevant. It's what wall street thinks. Not an itchy sell finger, just want clarity of results, is that too hard to ask from investors?

This is not a fact, but open for interpretation. That's the problem, everything Dr M says is open for interpretation. That's why the sp continues to languish and slowly drift down, because people in the know with money, aren't convinced.

Be clear about the endpoints and if you've achieved them! No ambiguity in the language to shareholders which allow for different interpretations. Yes or no, and no need to say it's not as simple as that. If you want sp appreciation, it is! If Anavex cannot put together a trial where this is possible, then they will forever be a micro biotech.

"Revenue potential" doesn't mean squat!!! Only real revenue! Show me the money, don't tell me how much you think it will be. This will languish until 2023 which is the earliest that I believe revenue may start from pediatric Rett.

Peer reviewed jounal will be next mention of PDD, probably late 1H 2021 and U.S. Rett about same time. Avatar Rett 2H 2021 and pediatric Rett 2H 2022 so no approval for anything until 2023. Stop whining if you are a investor about the traders. Dr M has made Anavex a traders paradise.

Yes, that is what he said. However I feel readout from U.S. Rett trial to be 1H 2021 and Avatar readout to be 2H 2021. I don't think there will be any approval based on either of these however, but not until pediatric trial readout which will be 2023 at the earliest. I base this on how long it has taken for Anavex to get trials completed and readouts to the public.

I certainly hope that Dr NP has realized the best chance for leronlimab is with the MHRA or the Philippines. The FDA is no friend to the American citizen, and for those who think that they don't have an agenda, this is proof that they do.

There will be no Rett data this year.

I do believe that Dr M is looking for a partner for future distribution. However it will be a couple years and he is just laying the groundwork. After Avatar Retts readout in 2H 2021 he appears to be hoping that the info will be good enough to go to the FDA since there is no real treatment available currently. However I believe that Anavex will have to wait until Pediatric Retts trial has readouts before data will be significant enough to convince approval from FDA. We will not see anything from possible phase 3 PDD trial for at least another 3 years, and AD readout will be about the same time frame. All said, the earliest that we see revenue will be late 2022 or early 2023, and this is from possible PA from TGA. So all those who are pumping, give it a rest for a couple years. This is a long term investment, not a get rich quick scheme.

As I recall he stated several times PDD by end of Sept. He still hasn't delivered anything of substance on that. Why should I believe him?

I agree! How soon do you think Anavex can start a ph 3 trial, and how long and how many patients do you think would be needed?

I can see some kind of approval after Avatar Retts trial, but not before. There needs to be more info than just what 31 18yr+ girls can provide. That will still take time, probably couple years if all goes well.

I do think it would benefit CYDY greatly if they could get approval for leronlimab for covid-19 with perhaps MHTA or Canada if FDA doesn't come through. Once approved, and not just EUA leronlimab can be prescribed off label and then revenues will come.

I am extremely hopeful that Retts trial will meet primary endpoints, and after the second readout that will bring about hopefully a PA from TGA and some revenue. I don't think the results from PDD are nothing less than outstanding, and definitely worth a phase 3. Both situations reflect what I have been saying. Revenue is what will bring up sp. I was talking about the issue of sp being a target of shorts, and until the words "achieved primary endpoint" aka axsm, Anavex sp will continue to muddle along for the next couple years.

I believe three words can quell doubts among investors. The words "achieved primary endpoint". Those three words for any trial Anavex has going on would be golden. Unfortunately I don't think we will hear them coming from Dr. M anytime soon, so the sp will continue to be a target of shorts.

CNBC would be embarrassed to have Anavex info because they haven't hit their primary endpoint. Along with being a microbiotech Anavex hasn't shown any results worth the time of day. It's not because they haven't put money in the plate, they don't have anything to put in the plate.

First I think Rett will get close to PA long before AD. Second to get FDA approval endpoints have to be met and Anavex seems to have trouble with endpoints. Yes I have read all the promising data that individuals have posted as well as doing some DD with regards to their effects. However the FDA is going to want to approve because of endpoints. It's up to Anavex to get a trial going that achieves that goal.

I believe it's possible before EOY 2021 as well, but I would like to provide time to file BLA and then any time it takes for review and approval. With Covid-19 taking so many resources I would expect there to be some delays