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Thanks Black-Ops. What do you think could realistically be the sp with MHRA and Canada approval for HIV? That's what seems to me something that could be achieved by EOY 2021.
I could not agree more. I have always said, revenue first then sp appreciation. My grandfather who was a farmer said build the barn first, the barn will provide the finances to build the house. Money talks, bs walks. Be patient folks, it will happen, apparently not as soon as most people want it to, but you can't rush this sort of thing.
The primary endpoints have not been met, otherwise they would have been released at CTAD. They weren't, so Dr. M will have to make the rest of the stat's look good. It's taking time to dress them up, so people are believing that things are not all that great, so retail is selling, and shorts are taking advantage. It could go below $3 before Rett readout which will be next year sometime, and then it needs to be outstanding and meet the primary endpoint. Hopefully Dr. M can design a trial where the primary endpoint is achievable for the next PDD trial.
I do believe that there will be revenue, from Retts after 2nd adult trial. If results are outstanding, and then it is possible TGA may give a PA, but that is still a couple years out. Then sp may slowly go up, I can see sp at $20 in a couple years on positive pediatric Retts, and if phase 3 PDD trial comes in positive, then AD as well, then who knows. It depends on the results of those trials.
I believe it will go down, as the results will not meet primary endpoints apparently, because if it did it would have been announced at CTAD. There will be a lot of meaningful benefits, that will lead to phase 3 justification, but I think just from the results of the trial sp will drop. It may go back up slowly, in anticipation of Rett readout, but that isn't a given.
I can imagine those individuals who said the same thing about axsm are very sad. I believe cydy is a lot closer to getting a product approved than axsm, yet look where their price is, based solely on meeting endpoints of their trial. I believe cydy will meet and surpass their endpoints very shortly based on the evidence of the 800+ individuals who have already taken it. Then what will you have achieved? Ernie Harwell who broadcast the Tigers baseball games had a saying about batters who watched strike three. Stood there like the house by the side of the road and watched it go by. You will be watching, bye!
I just was thinking that the wording "in addition to our filing for BLA" that they intend to complete enrollment for CD12 by EOY, seperate subject. Either way exciting times ahead.
NP also said in the pr that BLA was filed in UK and Canada. If CYDY gets a quick response, the first of the year could be very exciting if we hear positive things from DSMC.
I watched this and am not really sure that CYDY is in the mix. I would like to hope so, but because CYDY is so small, I am fearful that the large pharma's have a huge advantage. I think because these large biotech companies have had many trials in the past, FDA feels that they have a history with the medicine. With CYDY we are the new kid on the block and have to prove ourselves. Yes there has been the 800 or so patients with HIV, and several hundred more that have taken it for Covid, but what I saw gives me pause in that I feel CYDY has a higher standard to reach than those who have been there done that. I don't necessarily think the FDA is in the pocket of big pharma, it's just that many of those exec's know personally the people of the FDA and have developed a rapport, whereas NP certainly does not have such an advantage. Here's hoping the FDA puts America first and does the right thing and brings Vyrologix to those who need it.
The problem is revenue. With Dr M giving ambiguous pr's and CC's and constantly missing time lines for everything, he is no different than any other micro biotech. Problem is, institutions want clear info before investing. Other biotechs have tangible endpoints, Anavex has a bunch of hope so, maybe so. For sp to go where you think it should, there needs to be revenue.
Yes but you have to acknowledge endpoints have not been so far as we know now.
Of course not. It's just that everybody was saying they are irrelevant. There is a reason for trials. To achieve a goal of addressing a indication. An endpoint. Something Anavex can point to and justify a phase 3 trial or approval later down the road with further trials.
Then why is everybody clamoring for approval from 31 patient Rett trial.
Don't meet endpoints, no approval. No matter what you think, it's what the FDA thinks.
Well thought observation. Only problem is getting the product to the patients, and to do that you need approval, hence meeting endpoints. Changing a tire at 60mph, if you can find a method to do it would be great. Anavex has yet to start the car because they can't find the keys.
Not! I believe we will not get any info in CC or pr until after peer review. Why? Because Dr M has to massage the numbers to make it look as best as possible, and in a journal Dr M can postulate and wax on about potiential, without having to directly say we did not meet primary endpoints. My only hope is Retts because it is such a small population and SOC is poor, that in a couple years when ped trial is done they get some kind of approval and then some revenue.
Simple, in early 2019 they " met the predetermined endpoint". No ambiguity or floundering around. That's what started it. They provided clear evidence that their product AXS-05 was better than anything else in asssting individuals to stop smoking. It also was shown to reduce depression. But the bottom line is they met their endpoint, something Anavex should try.
The next time I think we hear from Anavex will be in a peer reviewed journal, likely be in Jan-Feb next year. I doubt any info in any quarterly CC just "we're getting all info together". Again, let's understand which Co we're talking about and the history of the CEO and multiple missed timelines. Rett maybe by mid 2021.
I think that if $20 is reached in 5 more years, I would have more that 500% return on my investment which started 5 years ago. I bought a little high, but I have averaged down to under $4 so that kind of return in 10 years I'm happy with. Besides as I said I do have a small portion I trade with and I know any CC Dr M has, Anavex goes down. So knowing that helps me position my trades.
It's pumpers that hurt sp as much as shorts. Retail investors buy in on the hype, push price up then shorts jump in and run it down through the stop losses set by retail. Get real! SP WILL NOT GO UP UNTIL REVENUE PERIOD!
Yes it is my opinion, and it also my opinion that when we finally get some indication of possible revenue, the institutions will want to see it, not just hear projections of it before they invest and support sp appreciation.
They do if they're called Anavex. No institutional participation to speak of, so that leaves mostly retail with stop losses, and the shorts run it down through them any time it gets much over 5. If PDD readouts don't come this year, I can see a sp under 4 by EOY, even then the readouts need to be really "stat sig", and not open to interpertation. Retts, will not be until late 1H next year, you can count on that, and again, without revenue, it will only provide an opportunity to take it down.
The only interpretation that counts is the one that brings in money. Until then don't complain that the sp is not where you think it should be. Until institutions interpret revenue potential and invest, Anavex will not go up and stay up. Retail may take it up because of the pumpers, but the shorts will thank you and bring it down and make money off the weak retail, rinse, repeat until revenue. 2 years away at least if both Retts trials are great, and we get PA from TGA.
How can you say we should be at multiples of where we are. What do you think should be the price for a company which has no revenue? A CEO who presents data that he claims is "stat sig" when there are many interpretations of what was presented at CTAD and has been constantly vague with shareholders. I understand that this is a small biotech, but that is the point! SP reflects what investors feel it is worth, and until some of the investors have deep pockets i.e. institutions rather than retail, then shorts will keep it down. As I've said multiple times, revenue begets sp appreciation, noting else. There's no crying in baseball I mean baby biotechs.
IR as being investor relations
IR said they are not attending Nov 16&17 conference. I seriously doubt we get any more info this year regarding PDD and I feel we won't get Rett readout until 2nd qtr of 2021.
Won't happen. Best chance is TGA after 2nd Retts readout in late 2H 2021. PA then would take 6 month at least to process after application. I know what schedule says but from experience I feel I'm being optimistic. Possible revenue in 2023 and then sp appreciation.
PA only possible after 2nd Retts readout. It needs to be great as well, so earliest PA will be in 2022.
No revenue! Incomplete data. Yea it was at a AD conference, but so what! Rett won't move it much either, no matter how "great" it is. PA, partnership, etc is what will bring in institutions which is what needs to happen for sp appreciation.
I looked at my account and date was actually 10-5-15 my 1st purchase. I was excited about the future possibilities and the volume was so high I had to get some. I have averaged down to under $4 over the years, and have listened to several cc's. I have looked at financial statments and presentations. Bottom line, money talks, BS walks. Until revenue, no real sp appreciation. However I am willing to wait and don't begrudge the shorts, cause in a couple years, I'll get mine.
Actually it was end of Sept 15 sorry.
I have been here since early '15. Very excited at first, entry point was $7+. I have averaged down and over the years I have become aware of the pitfalls of the pumpers as well as the dumpers. I have spent many many hours on DD and I feel that this is a tremendous opportunity for humanity, however I have also become a realist with regards to Dr M as well as the timelines of the different readouts and potential opportunities for revenue.
Retts results, or detailed PDD results will not move sp much. Only revenue. There are way too many retail positions to slow down any concerted attack by the shorts. Until institutions get involved, which will only be after PA or partnership, etc, the sp will constantly be a short target, get used to it.
Until there is a PA or partnership or other kind of tangible revenue source for Anavex, there will always be opportunities to short. Don't be mad, they're just trying to make a buck, just like most of the rest of us are. I prefer to think that Anavex will provide improved quality of life for millions of people down the road, and therefore have a large revenue stream, but if I didn't think there was an opportunity to have a return on my investment, I wouldn't be here.
Trading will be normal. It goes down in afternoon after morning run up. Trading pattern will not change until real revenue potential, period end of story.
Would leronlimab be effective against another type of virus? I understand that bacteria infections are not applicable, but is covid-19 the only virus that is addressed other than the HIV.
Is it possible to get EUA for all phases of Covid 19 once FDA looks at interim data for CD12 at 75% enrollment and leronlimab proves its efficacy, as well as having completed CD10 and the results from that trial? Or would that have to be a full approval? Could we then complete BLA for HIV so we could get approval for that separately?
I agree. These movements are simply a bait and switch, pump and dump by shorts and MM's. Revenue only will move the price significantly and when that happens it will be dollars per day as institutions will be getting in on the action.
I agree. However I would like CYDY to get EUA for the opportunity at revenue, but continue the trial, and get full approval when completed. Having a source of revenue asap is very important.
Don't you think SAVA shareholders are saying the same? I think Anavex should focus on Retts first for revenues sake. Then perhaps Fragile X or Autism because lets be real, its all about the money. If PDD phase 3 trial does good in a few years, great, but it will take revenue to get there. I would rather get PA with Retts, and not worry about AD. If it happens because SOC is poor, then so be it, but lets not count the chickens before they are hatched.