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And the p value for 2-73
reducing/halting brain mass loss was extremely low.
Even a person not versed in AD science has to take note of that.
As I recall there was only analyst questioning last quarter.
Sure some may have listened without asking questions.
However not sure if a sign analysts are losing interest in Anavex.
We heard that early last year and now 9 months later still nothing.
No reason the latest statement will be any truer since is also vague.
I’m a long time holder and believe we will get there but tired of promises that never happen in a timely manner.
What about all the new trials promised a long time ago to start.
Crickets.
My hope is delay only due to saving money for confirmatory AD trial FDA may require.
I agree with your point but I would like to see 2 and 3 month non treatment data.
If as good that will be mind blowing.
I hope they extended the period unless ran out of rats to dissect.
Unfortunately in order to prove a preventive hypothesis it will require a large very lengthy placebo controlled trial since AD progression at the early stage is a multi year process.
Best hope is approval for AD then off label prescription for prevention.
I’d be happy to add it to my daily blood pressure med.
Missling has said we will get Pediatric Phase 3 top line data before year end.
In the past we have never gotten results any earlier than promised and I think we have two more months of this bleed down before we get it.
However maybe a peer reviewed article on our AD trial will save us.
“may slow cognitive decline” ?
The PR says it DOES SLOW COGNITIVE DECLINE!
Did the author not read that in the PR?
Plus the excellent P values support that claim.
“may slow cognitive decline” ?
The PR says it DOES SLOW COGNITIVE DECLINE!
Did the author not read that in the PR?
Plus the excellent P values support that claim.
Yes however I want to see it on my national morning news program.
The obvious huge cost of new drug development are the clinical trials required.
To have a trial involving thousands of participants at a large number of sites in a number of countries over multiple years cannot be justified unless the phase 2 signal is reasonably strong, and if not cannot justify the cost.
With a strong efficacy and safety signal in a phase 2 a trial of no more than 500 participants in a placebo controlled triple blinded trial at no more than 10 sites should be adequate for conditional approval with a phase 4 to follow.
The big money would be from Medicare and the public political pressure to pay for ANYTHING new will be huge in addition to the “campaign contributions” cough cough doled out to the relevant politicians will probably be successful.
Once 2-73 submits an NDA this company could suddenly become a good acquisition target for big pharma eager to get into the “newly discovered” Sigmar1 therapeutic pathway .
This is very unexpected.
Although the n was low in the 2a trial the resultant graph shows a clear difference in response with the 50mg
group showing minimal decline with the 30mg similar to placebo.
As an organization supported by families of AD victims they will pressure the FDA for approval.
Until now Biogen has been the beneficiary of that pressure but now they will have a much better medication to advocate for.
This also indicates there was enough positive responses to have treating physicians request to continue treating.
The question is what percentage responded and how strong were the responses.
It would be very informative to know what percentage of investigators requested this extension.
It would probably be a surrogate for what percentage of patients showed clear drug efficacy.
However if the investigator had multiple patients it would be less clear.
I remember that comment.
I suspect that is why in the 2b/3 trial the mutated receptor group was left in.
This would provide data that shows although the therapeutic effect of 2-73 is less in that group it would still be better than SOC which would allow the NDA to ask for approval in all AD patients including the mutated group.
From years ago.
Would be nice to know how he is doing today.
Can the Australian press do a follow up since it was a big story at the time.
So why did the FDA approve Aduhelm on the basis of plaque reduction since plaque reduction has never been correlated in multiple studies with a statically significant reduction in AD symptoms therefore by this description should not be a validated biomarker for AD?
Job security.
Yes as a prophylactic since aging brings on an inevitable cognitive decline in the vast majority of seniors.
Not everyone will be able to get 2-73 prescribed as a prophylactic for AD however it will be available more easily prescribed for high BP.
I have high BP and would use that avenue to get it.
Adam Fartstain is waiting to ambush any new Anavex presentation, however if it is in a peer reviewed journal he will have little credibility with his nonsense and I suspect keep his trap shut.
I have to agree that after more than four months with no substantial follow up news on the completed Phase 3 AD trial we are justified in getting anxious and frustrated, and the share price reflects growing fear.
Mentioning MJ Foundation’s financial support was messaging that an outside organization after being shown data from Anavex’ programs was impressed enough to invest money to support the work on Parkinson’s.
The question needed to be answered is this a position that previously existed?
If yes why is there now a need to fill it?
The $858 is revenue per share.
Assuming $600 per share profit since cost of goods is low and distribution should be pretty easy using a conservative P/E ratio of 15/1 that gives us a share price of $9,000 !
The potential is mind blowing.
In addition the Australian government offsets some of the cost of trials in that country.
Anavex has already receive some of those benefits.
The market looks to be losing patience waiting for Anavex news on all of their programs.
Plus stock options to make for a wealthy retirement.
If Missling had any doubts about the trial results he has seen why would he waste time traveling to Australia for such a low profile event?
Nice that TGD gets a 40 minute slot at the very beginning of the conference.
Here is the 2016 AAIC poster that shows the EEG/ERP data.
I was impressed enough when I saw it to take my first AVXL position.
https://www.anavex.com/_files/ugd/7b494c_b06a833acc10439daf7f8a8017c25878.pdf
I remember when clear improvement in EEG/ERP was clearly seen when 2-73 was trialed early on.
The improvement was pretty much to normal. An objective observation.
Haven’t seen any mention of it in a long time and curious if it is even being looked for.
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1016/j.jalz.2015.08.130
Trial started in 2013!
All that time and money spent chasing the wrong target.
Potential buy out maybe.
Missling said we could be getting the OLE data from the Phase 2 PDD by year end 2022.
Why is it almost two months past that promised data release?
As I understand it Missling feels adding the forthcoming pediatric phase 3 Rett trial data to the already completed adult Phase 3 trial data was the most effective means to a FDA approval.
Getting the FDA pediatric Voucher will also allow for accelerated processing of another indication which could be used for the AD application.
If used to getting accelerated approval for AD it can get revenue stream 6 months earlier than standard approval time.
An 80 year old diagnosed with AD improved over the three year application of the small 10 mg dose of 2-73.
Halting would be great, improving is in another league!