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Looks to me like Anavex has a pretty good handle on how dosing for 2-73 works for various age groups by now.
I would not be surprised if trials going forward all have a titration component. We haven't seen enough of the data to determine if there is a ceiling effect on any dose for any indication. If there is a clear ceiling effect that would become the max dose. If not then the titration will go up to the 50 mg max that has been previously determined or to the individual patient tolerance.
The pediatric Rett trial may set some dosing limits for children. We will have to see the data to know about that.
The orange on the top and bottom of the blue line indicated planned trials. If the orange is under both the phase 2 and phase 3 portion of the line it means that both a P2 and a P3 are planned.
If you look at clinicaltrials.gov it shows that the -004 trial is the OLE trial.
I have an easy solution to that issue. I pick my cost basis as a starting point to evaluate the SP performance.
I have found that the ignore button is an immediate solution to that problem. Just sayin'.
All the things you mention are taken into consideration by most here. What you didn't mention is there are no trial failures so far. Trial failures are material information and I seriously doubt that the company would attempt to conceal a failure.
So the bottom line is the things you mention are not particularly important.
Trial results are all that matters. The rest is entertainment.
What percentage increase was that $20 billion bump in Biogen's MC?
That might be a better way to look at the situation.
AVXL Short Interest
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
08/15/2023 16,721,112 1,075,407 15.548636
07/31/2023 16,536,540 671,751 24.617068
07/14/2023 16,728,610 623,329 26.837529
06/30/2023 16,739,768 1,148,109 14.580295
06/15/2023 17,739,562 1,165,885 15.215533
You assume it is a delay. I assume it is a choice....based on the history of the company.
You may have noticed that Missling is known for playing his cards close to the vest. He chooses to not make a lot of information public.
As far as speculative, that would be why I used the words suspect and guess in that post. Great observation on your part
When you get down to it Missling is legally required to make SEC filings and disclose material information and that is all.
You don't have to like it and you can make up whatever reasons that make you happy for his choosing to not communicate more information.
He is the CEO and gets to make that choice.
I suspect he is preparing the data in a presentation form for the FDA to have them determine if the biomarkers are acceptable surrogates for the AD trial. Anavex has data on other biomarkers that is is recording as part of the trial data that are not currently accepted as surrogate biomarkers.
My guess is that Anavex is taking the sort of accepted surrogate biomarkers and pairing them with the additional other biomarker information to make what Anavex hopes is a compelling case to the FDA. I'm guessing that the gene expression data is significant part of the biomarker information that Anavex is wanting to put before the FDA. Anavex has to make the case that the gene expression is relevant to AD clinical efficacy. That will be a new concept to the FDA as it relates to AD so Anavex is going to have to provide a lot of supporting data for the FDA to accept it.
We have seen documents that show the FDA has accepted the biomarkers that Biogen provided as suggestive of clinical efficacy. Those same documents expressed concerns about how reliable those biomarkers are. Don't ask me for links. They were linked on the board and I didn't save them.
The point being that AD surrogate biomarkers are not as cut and dried as many think. Anavex is plowing some new ground as well as using the existing surrogates.
How has that worked out for SAVA?
AVXL is doing just fine.
Approvals are all that matter. Only the agencies can make the decision that counts on the worth of the trial results.
The rest is entertainment.
As an ex-programmer....I love technical terms.
Occasionally it barfs,...
Is that opposed to an expected bug? 🧐
If one did I don't see anything about it in SEC filings.
did one of our directors just buy 18,000 shares in the open market with personal cash?
That would have been J F Kennedy in 62.
As you wish. I have seen the process happen multiple times in my investing career.
You are correct. The SEC is asymmetrical because it does assume good news.
I picked up a few $7.50 options that expire next Friday. We shall see if that was a good idea or not.
If the trials failed that would be material information and the company would have already announced that.
You conclusion is wrong.
The way I have seen this work is a stock is in a range for a long time so it looks stable. People put in stop loss orders over time. The number of stop loss orders accumulates. MMs can see the stop loss orders on their book so they know what the situation is.
At some point when the stop loss orders are layered enough the MMs mover the sp down to trigger the first stop loss orders which moves the SP down enough to trigger another stop loss order. It becomes something like an avalanche. Of course the MM control the bid and ask so you saw larger orders trade at the ask and the ask price dropped which makes no sense unless the MM is playing games.
The MM now has a larger number of shares in inventory that are comparatively cheap so the sp will now move up so the MM can unload those cheap shares at a nice profit.
People that have "stink bids" sitting out there benefit from the sudden sp drop and bounce. No Tardis required.
Judging from the size of the prints, the mm found a number of big stops that got cleaned out.
I learned the hard way about having stop loss orders.
I love the way a 32K trade at the ask is followed 1 second later by a 15.7K trade at the ask 2¢ lower, followed by a 29K trade 1 second lower that is 11¢ lower. That pattern follows for the next 10 seconds with a 3 trades on the upside before dropping price on large trades at the ask continues for a few more seconds.
And that, boys and girls, is the MMs doing their thing via a manipulated stop loss cleanout.
I'm seeing posts to deleted messages being restored. The posts don't see to pass the stand alone test. Is there a new interpretation of the rules on that issues?
2 years in jail for one guy and 1 year for the other. Felony convictions and fines. I'm guessing they are looking for a new line of work when they get out of the slammer. Not something I'd want to deal with.
More importantly the company was fined $902 MILLION. That is a bit more than a slap on the wrist.
Same question for you?
PPD OLE was during the Covid shut down in Spain and Australia.
That is hardly a representative benchmark for the AD P3 OLE.
Maybe they were short on the other side of the house and they used those shares to cover the short position.
Maybe they needed the cash for some other play.
Get over yourself. It was a reply to a post content.
Relax. The bold was intended to highlight an additional portion of the linked material that was not highlighted. I found that when I read through the entire document.
I thought it was worthwhile pointing out to the board.
He told us he'd submit it on Avatar
Stuff it tootall.
You make it sound like the trials don't exist and Missling is really Elizabeth Holmes.
I doubt that there are any significant shorts on the board. There is a 16,000,000 share short position. The 16 mil shares position is the force that is influencing the share price.
Probably not a good use of the voucher. Here's why I think that.
Rett will hit the market quickly and will command a very high price. That will be a big revenue stream.
AD approval will rapidly cut the price of the Rett drug and it will take a while for the AD revenue stream to ramp up impacting the revenue stream.
Much of the NDA for Rett will be reusable for the AD NDA so that will cut the prep time for the NDA down significantly. Presumably the company is already working on the NDAs for both drugs currently.
The company can apply for priority review for AD once the Rett NDA is in the hands of the FDA. The FDA doesn't have to grant priority review but it might. Priority review has the same effect as the voucher on time frames.
Selling the voucher funds additional trials for other indications immediately while it will take some time for the AD revenue stream to ramp up.
So, do you conclude from this statement that Anavex will never "deliver the goods" or is this just a short term issue?
AVXL simply has not delivered the goods.
His $11 target is correct in the short term. Give him a cookie.
'Tis the longer term targets that I am interested in.
I'm not in the WGT AD camp. I think it is likely.
I am in the WGT Rett camp. I don't see anything that suggests something other than approval for Rett. That will validate the MOA and things get interesting after that.
My opinions are worth exactly what you paid for them. Invest according to your own internal drummer.
Since the metaphor of choice is cards, It's much harder to stack the deck when the cards are still in the pack.😎
Additional quote from that article you linked. Highlights are mine.
The principle consideration when evaluating whether to modify an endpoint is whether the decision is independent of the data obtained from the trial to date. If the decision to revise endpoints is independent of the data from the trial, then such revisions may have merit. In fact, Wittes [8] encourages consideration of changes in long-term trials, as medical knowledge evolves or when assumptions made in design of the trial appear questionable. Wittes further argues that researchers “may consider changes to the primary endpoint when the trial has airtight procedures to guarantee separation of the people involved in making such changes from data that could provide insight into treatment effect” [8].
I'm comprehending exactly what was said. The conclusion that was drawn is based on nothing.
I don't know why Missling hasn't provided additional data and neither does anyone else outside of the company.
AFAIK the endpoints can be changed before data lock. If there is some rule that prevents that on a P3 trial please
provide a link to it. I'm not suggesting that is a good idea but rather I don't think it is prohibited.
I offered possibilities as to why additional data hasn't been provided. There are many more possibilities, some more likely than others.
There are many possible reasons for Anavex not providing additional data "after all this time".
Some as simple as Missling chooses to not give out additional information until NDA filings are made. Others are more complicated, like data is still being crunch by the AI platforms, or he is setting up the shorts.
The company has repeatedly stated that the endpoints were met. If you think he is lying then Anavex has got to be a wonderful stock to short. The class action lawyers will own Anavex if Missling is lying.
The important part of this conversation is that even at the lower doses the mutant type still responded to 2-73, they didn't respond as well as the wild type. Missling has made this point in the past.