Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
We have this?
Notice that there are no ambulance chasing law firms coming after Anavex even after a 50 percent SP decline in 2022.
Ignore the noise, wait for the updates!
Sure thing ffrol…..Merry Christmas
Keep your head buried in the sand ffrol. If Pfizer or Biogen presented A2-73’s data, it would be headlines on every news outlet as the new “miracle drug “
Yes, I agree, it’s not the way things should work.
Unfortunately, that’s the world we live in today.
I am more convinced than ever that we need a BP partnership to advance AD/PD.
Like it or not, large BP’s have influence with advocacy groups and the FDA.
The Alzheimer’s Association is in Biogen’s back pocket…sad
3rd death from lecanemab-
“SCIENCEINSIDER HEALTH
Scientists tie third clinical trial
death to experimental
Alzheimer's drug
Amid lobbying for lecanemab's approval, a
newly revealed death adds to doubts about
safety of antiamyloid antibody
21 DEC 2022”
https://www.science.org/content/article/scientists-tie-third-clinical-trial-death-experimental-alzheimer-s-drug
Thanks McM! Great article. Good to see that we are starting to get some positive press!
Ps- I’m sure it will be picked apart by certain posters on this board
Haven’t heard from MayoMobile . Didn’t he say that he was going to give an updated assessment of the initial CTAD data?
“A video of my initial conference call post-data on
1 Dec can be viewed here. Note that my
impressions were brand new and some of my
analysis has shifted since this video.”
No, it doesn’t. Why don’t you tell us about it.
Adam Feuerstein@adamfeuerstein
Good tidings! 'Tis time for my list of the worst
biopharma CEOs of 2022:
Clay Siegall, Seagen
Alexis Borisy, EQRX
The "blinded data" PIPE gang
Chris Missing, Anavex
Linda Powers, NW Bio
Plus: Remi Barbier, Pat Mahaffy, Paul Stoffels, Jason
Kelly
https://www.nature.com/articles/d41586-022-04444-3
Mentions Anavex
“ Another Alzheimer's drug, called blarcamesine
developed by Anavex Life Sciences in New York
City - will continue to make its way through
clinical trials. Blarcamesine activates a protein
that improves the stability of neurons and their
ability to connect with each other.”
Is Anavex going to have a problem getting a clear data set for the 30mg vs 50mg arms due to the titrations that occurred during the trial?
RI Research Update
• Tine 12/10/22- AVXT.
With regard to late Friday's Seeking Alpha article- At the end of the day ... there 1s no loss of taith here. Below 1s what I have so far on this topic, but I have
heen
unable to
get a hold of Dr. Missing this weekend to get his perspective. The
next regular issue, including a 4-page analysis of the Phase 26/3 release
situation, goes out Monday after the close. Not to scoop myself too much, this below is excerpted from the upcoming issue (state of the art)-
"I warned short attacks were likely. And it has been brutal. I hope the Company 1s working around the clock to get some of the missing data out before
shorts have totally decimated the stock. Kegarding a feeble attempt made by one or them in an article on seeking Alpha released after the close Friday- The
idea that this guy (who touts a PhD but doesn't say in what field or trom what college) can try to discredit the Company's statistical analysis (which
was undoubtealy prepared by actual experts in statistical analysis and which the Company nas already realtirmed was correct on 12/3 ), wuhout having the
individual natient data. is absolutelv ridiculous. He just used the limited ton line numbers on a slide. And the idea that it should include all natients that started
the trial.
when
10-20% of them often routinely drop out in all clinical trials (for any number of reasons, which 1s a separate analysis) and therefore dian't take
the
drug for 48 weeks and therefore didn't have data at 48 weeks, is even more ridiculous. What I want to see done is one by one for each patient that took the
drug
for 48 weeks how did that patients score change, then look at the next patient and the next, etc. And then take the mean of all those numbers. That 1S the
thing that makes sense and is what An
avex provided (topline) in reporting the 45% reduction in Cognitive decline vs. placebo
And remember Anavex 1S not a one trick ponV. More Parkinson's data 1s due this month. Rett data in V2. While I too wish we had gotten some additional data
on the Phase 26/3 Alzheimer's trial. I am not disanpointed on
what we da receive so far
and the nest data will follow once thev drill down.
) that. I believe it that dat
supports what we have seen so far, there is enough for the FDA to someday approve A2-73. It could be a country by country thing sooner than later also. ..perhaps Australia? But in the interim I simply believe
the full data set should support a higher stock price (if not a takeover offer) while an additional trial gets underway. I think the results have been misrepresented by some (and this may continue) and that AV AL has
gful data I discussed above. The stock hi
attacks wind down by Christn
~14 43 mignt DE
10V 10r a•
So what would have happened if they ran the trial with only 50mg high dose and placebo?
The trial would have easily passed?
There would be no dose dependant comparison?
Anavex has two former FDA employees that were both involved for years with IND’s, NDA’s and drug approvals.
Although we never hear much from them, they are on the payroll and I’m sure they are involved with the trial protocol and discussions with the FDA.
Although Anavex is a small company, it has some very seasoned, well rounded employees that I trust much more than message board FUD spreaders.
From ST-Kettil2022
Something that may help
people understand what was
released and emphasized in the TLD.
The endpoint was originally stated as
"improved over baseline" and was
changed later to a "slowing of
decline". The responder analysis for
improvement was pre-specified in
the data analysis plan, which is a
formal part of the approved trial
design package, and is the
appropriate measure for assessing
'improved over baseline". 87% and
167% greater chance of improvement
on the 2 primary measures at p's<
.05 meets this endpoint clearly and
easily. The drug helps some patients
improve (more than just the placebo
based improvement). The
company's analysis plan included the
CDR-SB decline from baseline
analysis as the measure of
comparability to other trials like
lecanemab (which used this as their
primary endpoint). This analysis was
also significant and showed a clear
benefit of drug. It's unclear how much of the
additional analysis then had been
done Thur for CTAD or by the Mon am
CC. Missing said they didn't have
data on the change in any measure
over time, which does indicate how
much analysis, even by Mon am still
needed to be done ... just on the
behavioral data. There is
uncertainty, but there is lots of
analysis to come ... and the
explanation that Missing or the
company is shady is nonsense .. as
much nonsense as the reaction to the
Mon earnings CC that had people
claiming the data must be bad for
there to be Missing coy responses
about waiting til Thur for the data.
Simple question YES or NO. Can Anavex legally claim that they met the endpoints using the “odds” method even though it’s not the traditional accepted method that was expected?
If yes, then this a nonissue and we have to wait to see what the full data shows and what the regulatory agencies have to say about it.
Mayo? I am anxious to read your updated report ! We could could use some encouragement.
I still have a hard time believing Dr M would stick to his guns even at the CC if he didn’t believe it. He even said things like “ results are better than expected “
He surely knows the seriousness to the company if not true.
I’m in shock that this is happening.
This tree shaking has to be about over!
Didn’t Anavex say in a 10q recently that they hired a new/different CRO?
Could it just be as simple as the full data will have all the missing pieces and everything will make sense?
I find it interesting that no MB experts have attacked Mayomobile’s CTAD report?
“they just changed the endpoints at the last minute.”
Did they really? Is that allowed?
I trust that everyone listened to the CC yesterday?
Dr Perry has been a top AD KOL for many years. Do you really think he would agree to do this cc and give the positive comments if he thought that there was something fishy going on with the reported results?
I doubt he would risk his reputation on questionable data.
Are we really supposed to believe the ultra conservative Dr Missling is going to risk large lawsuits and possible jail time fabricating missed trial endpoints?
Fudsters are really working overtime.
Wait for the full data release.
I am really hoping when EXCELLENCE data is released, they triple check it from front to back and hire two third parties to verify the data!!
Would Anavex have been better off not to present at CTAD. Issue a well ironed PR, breakout the 30-50 dose and have all its ducks in a row?
What would the reaction have been if the same data was announced from a Merck/Anavex partnership at CTAD?
Such a huge indication as Alzheimer’s is a very tough hurdle for a small company like Anavex to take on by itself.
Hopefully they announce a partnership soon.
Congratulations all longs!! Feeling great tonight!
I don’t care about the share price tomorrow. I’m already counting on shenanigans.
All that is important to me is we hit all endpoints! Some halted and reversed remarks would be great!
Looks like no morning PR.
T-12 hours! Today is the day many of us have been waiting for for 7+ years.
Fingers crossed!
Anyone heard from Mayomoblie?
Still don’t know why he used the wording “we remain on track to deliver “
Is there really a chance the presentation will be scrubbed?
How can he still not have the data a day before the presentation??