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tootall, other than that you like it right?
tootall, lookup Normalcy Bias.
Steady, I think that is 0.5 SD. The threshold on the vertical axis label, refers to the actual threshold for each test type, <=3 next to ADAS-Cog for instance.
The placebo for Emerge declined 5.2 and the Emerge High dose declined 3.78 pts, so setting the threshold at <=3.0 is pretty gratuitous by Biogen. HAHA...setting the threshold 0.78 pts above the reading, in other words the threshold is at 58% of the placebo decline. HAHA
Anavex put the threshold comfortably ABOVE the baseline (at-0.5), to add confidence. NICELY done!!
Remember BIogen ran TWO P3s. Emerge, and Engage were TWO nearly identical P3 trials EACH with about 1600 patients for over 3185 TOTAL!!
The Engage results were swept under the rug, as Engage results were less than half as good as Emerge. Biogen got rid of the extremely smelling c$rap and just kept the bad smelling c$rap!
That is what Adu data is, and why every respectable doctor/hospital rejected it.
Steady, somebody called SteadyTrade on Stocktwits, posted Biogen expects Lecanemab to be barely profitting by 2026. If that was you, do you have a link to that?? Could relate to Anavex pricing if true.
Steady, IIRC Dr.M said he used the odds ratio, just because biogen used it with their report on Aduhelm. He used it as a comparison to Aduhelms numbers, emphasizing A2-73 numbers were better, and with a higher threshold.
Nonsense!
Liked TGDs candor with his answers. I chuckled, when, after only two questions, he was told there are no more questions. Dr.M quickly said THANK YOU, and wrapped it up. He seemed relieved. LOL
AUC was required/requested by FDA for small sample sets. Not Anavex invented. Keep up.
YES, agreed, all four designations are intended to speed up the process in various ways. But Breakthrough Therapy and Accelerated approval, are generally linked to accepted “surrogate endpoints” and biomarkers. (Nice for downstream ABeta drugs with minimal clinical benefits!) That leaves Priority Review and Fast Track for Blarc.
Blarc for Alz should qualify for Priority Review and Fast Track designations. Blarc already has Fast Track designation for Rett syndrome. Not sure how this would affect trying to get approval of Blarc for ALZ.
Even ignoring the Blarc Rett Fast Track question...
For Priority Review, Blarc for Alz, meets the requirement of significant improvement based on evidence of increased effectiveness in treatment, prevention, or diagnosis of condition. For Priority Review “FDA’s goal is to take action on an application within 6 months” . Six months seems to be the fastest route there is, nice! This seems like a great path for Anavex to take.
This FDA link describes all 4 designations.
FDAs four designations- link
As I see it, for Alz, Blarc easily qualifies for Priority Review and Fast Track designations.
Blarc may not qualify for Breakthrough Therapy and Accelerated approval, as they are generally linked to accepted “surrogate endpoints”. As you point out, Anavex does not seem to have any designated surrogates in any trial. (FYI it was the Accelerated Approval pathway that Biogen was able to use based on “reduction in brain amyloid as measured by PET”. Where amyloid was an accepted surrogate.
On the other hand, Blarc may quailfy for Breakthrough Therapy, meeting the requirement of “A significantly improved safety profile compared to available therapy, with evidence of similar efficacy.”
Steady - How long will it take to get to full Alz revenue rate, after approval?
I think the other interesting question is how long after Alz approval could Anavex see first revenue? This question is very interesting because, with revenue comes stable SP, and increasing SP. Both important to investors. So, first lets look at the question of initial revenue.
Initial revenue will be highly dependent on how much groundwork Anavex can get done before approval. I remember Biogen was dosing people within two weeks of approval, so that is probably the absolute minimum starting time. The question is how close can Anavex come to that? Anavex does not have MRI constraints, and will be cheaper than Adu($57k), so there would potentially be more patients signing up for Blarc without insurance. The major hurdle will be distribution. Anavex has been planning on doing distribution for Rett themselves. How far along will they be with this, if/when they get Alz approval?. Would they be able to handle the first few thousand Alz patient drug requests, until the 'big' wholesaler/distributor comes on line? Signing a contract, partnering, with a wholesaler/distributor is a major hurdle. The wholesaler agreement could be setup within weeks to a few months. As I said, work on this could be started before approval. So initial Alz revenue could be within a few weeks, to a few months after approval.
The limiting factor in getting to US FULL Alz revenue rate, will be getting approval and setup with Medicare. They are the largest insurer in the US of people in the usual age range for Alz. This will be the biggest hurdle, and most time consuming one. Gov processes, like Medicare arrangements, I have no idea, maybe 6 months. Just a SWAG on my part would be 4 months to a year, to get setup with Medicare. Anyone with experience here, or better estimate would be welcome! So then, my estimate to reach FULL alz revenue rate would be 4 months to a year.
jmvho, nice figuring! And to answer the final question....Given your $3.2B net/year, it would take round about 22 days to recoup the AA value of $100M. To my mind, that becomes inconsequential.
jmvho/Steady. Nice figuring! Biogen priced approved Adu at $57k per year, and Lec at $27k per year. Assume Dr.M prices Blarc at the low end of the market range ---$27k per year. And there are 5.7million Alz patient in the US. Assume any market penetration of them. Blarc seems superior and at a better price, so customer should be pleased.
Given the above, I have four questions:
1) What would the yearly revenue and earnings be?
2) What should the buyout priced be?
3) (Steady) How long would it take to recoup the assumed $100,000,000 for AA Rett?
Can you guys help?
Welcome Joseph. Companies always know lots more about their business than they tell. Ex. All the various trial OLE data.
Great OM! Seems like something IR might be interested in. 40% increase in SP would be very NICE! BTW did you provide them with any documentation?
What a coincidence. Within minutes of conference, SA comes out with their piece. Without even waiting until after the presentation! Smells like an agenda to me.
Treden, I couldn't tell you how many are naked shorts, or multiply traded in the same day. Maybe someone more knowledgeable of these mechanizations, can answer those Qs. These are the numbers reported by fintel.io and nasdaq.com.
I have seen others say that the numbers of shares of AVXL available to short are very low. Seems like that might be the case if you look at https://fintel.io/ss/us/avxl
under "Short Shares Availability". But I have not been tracking those.
For those that found this interesting, I posted a plot of Short interest as a percentage of total volume:
investorshub.advfn.com/boards/read_msg.aspx?message_id=170684028
I always wondered why the percentage of Short to total volume (Purple) stays fairly well within a band of 20% to 35%. That is the short volume closely tracked the long volume! I would not have expected that over a period of time. If anyone has a good explanation, I would like to hear that also.
Interesting AVXL Plots around Dec1
(This is not technical analysis...just data analysis!)
I decided to look at this data as that time period was very interesting.
Below are two plots.
The first is a composite plot, by day, of Total Volume of AVXL, Total Short Volume of AVXL, Closing Price, and Short interest as a percentage of total volume.
The second is a plot of the millions of dollars of AVXL stock that was shorted...In this case income to the shorter.
Several interesting points from the composite plot:
1) Note how the Short Volume and Total Volume track so closely (Blue and Green).
2) The percentage of Short to total volume (Purple) stays fairly well within a band of 20% to 35%.
3) For all the volume, the SP(Red) stays within a range of $13 to $7.7 from 11/17 thru 12/9. A fairly narrow range considering the massive volume swings.
Questions raised:
A) Is it a coincidence that the Short Volume tracks Total Volume so closely, and around 20% to 35%?
Related to this, is there an algorithm specifying this percentage in some buy/sell program(s)?
B) It appears the price stayed in a narrow range (in my opinion). Was the above mentioned algorithm used to maintain the price level, or is this just an interesting observation/coincidence?
Regarding the second plot of millions of dollars shorting AVXL...your questions and conclusions are as good as mine.
MOST SOURCE DATA IS FROM FINTEL.IO
DrMisslings comments about moving forward with approvals:
These are from Dr.M on the CC update of Dec1. It sounds like it is finally "game on".
Setting the stage>>>
At this point we can confirm that all efficacy data, as presented at CTAD, are accurate.
But before I do that, I would like to emphasize that the data is even better than anticipated.
We know from our previous two dementia studies, namely the Anavex 2-73 Alz disease phase 2a,
and phase 2 dementia study in Parkinsons, that we have a strong therapeutic candidate.
We are doing everything in our power to bring this convenient, oral once daily treatment, to patients as soon as feasibly possible.
We plan to meet with regulatory authorities to determine the next steps.
Yes, so we plan to very aggressively now to engage with regulatory authorities
both FDA as well as EMA, UK and pacific Asia, to aim for interaction aimas scientific advise
conditional marketing authorization, a procedure which is analogous to accelerated approval in the US.
As well as engaging with the scientific medical community, payors, with patient advocacy groups in key
geographies around the world to really aggressively seek the path forward because of the
benefit and unmet need existing for this pathology. Ultimately, it will really be down to the
full data and the discussion with the authorities of how the next stage will play out.
But these are the steps we are doing to be very aggressive.
Interesting notes on TGDs presentation:
He obviously has the much of Alz data in hand.
If he knew of ANY problems with the Alz data, he would have probably been doing some backpedaling, or 're-explaining' during the presentation. He did not back track on anything. The slides were exactly as previous presentations. Instead, for example, regarding the Sigma 1 WT gene, he actually highlighted the variant vs. WT, whereas I thought he had been minimizing the differences in recent presentations.
Was it my imagination or did TGD seem to be emphasizing the similarities between the Alz and the PDD trial, as if to say, expect Alz results to be like the PDD results. Of course there is the slide where "70% of genes which are known to have pathological implications in both alzheimer and in Parkinson", which he went over.
Then the PDD episodic memory slide, where he said, the medium dose stopped the decline, which is already fantastic, but the high dose group was above baseline.
TGD then said, but the reason I want to remember these doses is they are exactly the same doses in the upcoming Alzheimer study - placebo 30, 50. This episodic memory test is highly correlated to the ADAS-COG (Alz), which was published many years ago.
A little later he said --Remember this Adas-cog which you will see in a few slides, is also the Alz primary endpoint. So it is quite intriguing to see this data.--
When my teachers said 'Remember this', it was important and would be on the test!
Exactly! And with all eyes on avxl drop all those 'catalysts'. Drive the SP up, making it more difficult for a buyout! I think Dr.M is finally going to take the cards away from his vest and play them all.
Investor, Group1 patients were 1014 and 2006, according to Doc328 findings .
See his post 358446 of April 26 2022 at 11:09AM, investorshub.advfn.com/boards/read_msg.aspx?message_id=168662278
At the time I confirmed these two (1014 and 2006) on my own.
Your findings of 1011 being a Group1 patient does not make sense as one of the Group1 requirements was defined as being High Mean Concentration. Whereas 1011, as you say, "1011 had next to no concentration".
Whatsay?
Treden-Don't know anything about that.
Gator. Nice. That explains how hit pieces can come out during a presentation. Saw that happen with the NWBO presentation as well. AF types work awfully hard!
"Credentialed media can request advanced copies of abstracts by emailing CTAD media representative, Melissa McGue at MMcGue@MessagePartnersPR.com with agreement to honor embargo"
This is how hit pieces are able to be published within seconds of data release to the public...
MS population is 1Million same as Parkinsons!! BIG
Alz is 5.9M. So MS is 17% of ALZ
References: healthline.com. (nationalmssociety.org says 913000)
All numbers are for U.S.
Thanks PW. As far as I can tell it looks the SP started up approximately 7/26 2021 and started down on 9/27 2021. The Cortexzyme PRs for those dates are:
PR of 7/267 shows
7/26 Cortexyme Presents Data Linking P. Gingivalis to Elevated Levels of Phospho-tau217 Reinforcing Evidence of Pathogen as Causative Agent of Alzheimer’s Disease at AAIC 2021
Cortexyme to Present Results from the GAIN Trial: A Phase 2/3 Study of Atuzaginstat in Mild to Moderate Alzheimer’s Disease at CTAD 2021
According to a poster on another msg board...
Last year Cortexyme(CRTX) went to $100 just on announcement that trial results were coming.
It seems that was conservatively CRTX ran up to a $3B market cap.
AVXL is now at $1B market cap, so for AVXL, that could project to a triple SP by Dec.1.
P.S. Cortexyme eventually got bad news from the trial, the SP plummeted, and the company changed the name to Quince Therapeutics, making it difficult to run down specific dates of announcement, outstanding shares, etc. But it appears they ran to $3B market cap. Interesting anyhow. Just having some fun with this. Can anyone confirm this (CRTX) scenario, or correct details?
Abe, thanks for looking that up!
Good to know.
TTT Many Thanks. Date SET!
Dr.M's negotiations have worked very well. The SHAREHOLDERS are happy. low dilution, money in the bank.
Dr.M good negotiator? YES! With Examples:
1) Nice deal with Australia TGA to fund trials there.
2) Another deal with a charity in Australia to fund trial there( I forget the name- Biocheck it).
3) Deal with MJFox Foundation funding PD/PDD clinical trials(s)
4) Negotiated good compensation package (good example biochecker).
5) There is a good reason he has $150M in bank, so he can negotiate from position of strength(not needing money, if you ask)!!
Just what I could come up with off the top of my head. Yes, compensation packages are negotiated. Thanks Biochecker for adding that one.
Partnership NOT the reason for NO TLD/CTAD PRs!!
Reasons:
1) Negotiating strategy. One does not negotiate early from a position of weakness. That is no data in hand, or no imminent approval. The converse is then true, one wants to negotiate when sales/approval are imminent. Approval/sales is down the road a while, not now.
2) Announcing a partnership with nothing to sell would be silly. At this point Dr.M should be holding DISCUSSIONS with VARIOUS POSSIBLE partners (distributions/manufacturing). He is not discussing TERMS yet, just assessing, and narrowing the candidates.
3) You do not want to announce a partner before discussions with FDA, as that would be seen as putting pressure on them to approve drug. The protocol is never to be seen making assumptions of what the FDA will do!! The earliest I would expect to see partners ANNOUNCED, would be after significant discussion with FDA, maybe only after approval, or imminent approval.
Dr.M is a known good negotiator, with years of pharma experience. So you can assume he knows all this. Trust him on this.
Yes, all good reasons why TLD/CTAD PRs yet!
1) Anavex may not know the outcome just yet, or 2) they know TLR and want more time dig deeper, 3) they will release TLR when ready independently of any CTAD appearance, 4) They will present when ready with more subgroup analysis highlighting encouraging signals to drive the design of a new P3 Precision Medicine trial that Anavex may or may not want to present at CTAD.
Read what I said! If he has time for ctad great. That is what I said. We do not know when, or even IF he has the trial data. He might have just received the alz data today, for all we know. TLD is priority #1 !! If he can do ctad GREAT, as I said. Don't make assumptions about what he has and what he is doing.
KB, TLData is priority 1 for Dr.M, NOT ctad!! I want him analyzing the alz data for top line data PR. If he somehow has time for ctad great. PR for ctad would be great, but NO ctad PR means nothing, as he may be taking care of TLD. There will be many conferences for him after TLD, if ctad is missed this year.
MultipleSclerosis patient pop same size as Parkinsons
In other words huge possibilities.
Anavex interest in MS is based on the very promising MS studies by Dr.Lisak at Wayne State U. Expect a trial for MS too.
falconer good points. One more...
Will the caregiver get excited? Will the caregiver of a Lecanemab (or Lillys donanemab) patient, even be able to see the affect?
It is not like the patient will start driving again, or reading again, or playing piano again. These are A2-73 anecdotal patients.
Presumably, 27% is Lecanemab's average improvement over normal decline. Maybe the better responding patients actually have only a 50% decline with Lecanemab. Will the caregiver even be able to notice a better patient with a 50% reduction in decline? With dementia, it is easier to see an improvement(very rare!) than a modest change in rate of decline(without doing testing).
This is just a rhetorical question, tieing(sp?) your comments in with Mayos allusion to statistical vs clinical significance.
Doc328, what do you think of this?
Lilly (March 2021) regarding their Alz P2 trial PRed
"Specifically, at 76 weeks compared to baseline, treatment with donanemab slowed decline by 32 percent compared to placebo as measured by the iADRS, which was statistically significant. "
"Lecanemab treatment....compared with placebo at 18 months by 27%."