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.
Dr Missling said everyone is working on the EMA application. Shorts are on extra thin ice here.
Thanks for enlightenment Hosai. Appreciate it.
Ok. Didn't realize that.
Yes, I looked that up in the last hour and saw 200 days. These are working days so ~20 days a month would require 10 months. So possibly August 2025 depending date of submission . I do hope it's sooner, but I also realize the data likely goes through a lot of hands as it moves through all the European states.
Yes. I believe we have opportunity to witness history in the making. According to the article in nidans post if correct the EMA should give an answer within 67 days of receiving MAA.
Wow thanks nidan7500. This sure caught my attention- While Anavex is still developing its MAA, blarcamesine is expected to be approved throughout the European Union given its positive Phase 2b/3 clinical trial results and past designation as an orphan drug (a pharmaceutical agent developed to treat certain rare conditions). Blarcamesine has exhibited a robust safety profile throughout all of its clinical trials, with its only side effects being transient mild dizziness.
As we wait be thankful we have the goods and a shot at approval. Heck most small bios don't even survive.
Agree. I once read an exert of his touting Leqembi.
"In March, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance to help drug companies develop medication to treat cases of early Alzheimer’s disease that “occur before the onset of overt dementia.”
Could be perfect timing for Anavex
https://www.theepochtimes.com/health/should-alzheimers-be-treated-before-it-becomes-symptomatic-experts-weigh-in-5616383?utm_source=goodeveningnoe&src_src=goodeveningnoe&utm_campaign=gv-2024-07-01&src_cmp=gv-2024-07-01&utm_medium=email&est=AAAAAAAAAAAAAAAAZOc8dxYb6djJ5LwB8GZWBn1BtHFmWXjh8PCDQuhsH40%3D
The company is aware and has interest in A-273 as a heart benefit. AFIB is a common occurrence.
https://www.anavex.com/post/anavex-life-sciences-announces-notice-of-allowance-for-u-s-patent-application-anavex-2-73
“This new use of ANAVEX®2-73 (blarcamesine) will be exceptionally important for Alzheimer’s disease patients because the advanced age of these patients make them also more susceptible to heart disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, adding: “We are extremely pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). When it issues, this new patent will fortify our robust patent portfolio relating to ANAVEX®2-73 (blarcamesine), and further demonstrate our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio”.
Approval would likely add 5-7 years of exclusivity.
We have a good chance of AD approval at some point but still nothing for sure. CNS is a complex undertaking, expect failures to happen. So far we've been pretty lucky.
Ouch day. Trial proceeds
Ha. No other company has reported seeing a reduction in brain volume loss because it's not happening. Mabs are seeing brain swelling and bleeding which is a problematic side effect. However how small the reduction in loss, it is an excellent outcome.
The ATTENTION AD study is scheduled to be reported this year.
Our safety, efficacy, ease of treatment, lower costs, no MRI follow ups compared to mabs may just make Blarcamesine very attractive to European regulators.
Over time he was proved right. The science here is proving out over time. Waiting to see what the regulators have to say.
So the the standard bash these days is Missling has an accent, he dresses differently, his hair is unkept. How many know Moses dressed funny, had a speech impediment but still delivered millions.
Sounds as if he's describing Albert Einstein
Is this the start of the short squeeze???
The EMA has gone over full data which is everything you and I haven't seen and said apply for full approval. The need is great.
You make an even fairer point. I also don't believe this company would have just gone through the time and process to better stabilize and "develop a new, pharmaceutically acceptable form of the active ingredient" of a unapproved, relatively unknown compound without first having been in talks with the owner (Anavex) who owns the intellectual property rights, There may be something broader going on here such as building for manufacturing and distribution.
I'll send Missling a thank you card:)
Interesting work being done in Europe. Their invention is a better way to uniformly stabilize "Blarcamesine's" active ingredient. Possibly being done for marketing.
Copied from stock twits- Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide. At present, there is no approved treatment for Fragile X syndrome.
No approved treatment caught my eye.
Thanks. The arduous application process is the same for every company. Due to their size BP has departments dedicated to lead the process, but a small cap, Anavex's size, as with all small cap bios have to ramp up in hiring competent employees. But in the end we'll get there.
Can you point to which webcast Missling reportedly said 1 million pages? I never heard him say 1 million pages but it has been bandied about this forum ad nauseam. Thanks
Hope so too, the need is great.
Ha. Not contemplating as we already know the successful A-273 AD trial results. EMA said apply for full approval. EMA response was great to hear.
A-273 having a high likelihood of approval keeps some up at night.
Agree. It is strange. Glad to see the FDA recognizes the challenge of judging any microscopic changes in early AD daily living. It will be interesting to see long-term OLE participants.
Yes I think ADL would be a more appropriate measure in moderate participants.
The bottom line is ADL changes in early AD are very difficult to judge in a short span of time and now going forward the FDA no longer regards it.
Well a new antifungal patent was recently applied for. So, yes, there is still some activity.
OK thanks, that's how I read it also.
So restricting the golden parachute failed?
That PDD OLE report was from Mar 30, 2023, so just a year ago. With a new phase3 coming up, my guess is it will be added in conjunction with approval.
Sorry my earliest post was on AD OLE
ANAVEX®2-73 (Blarcamesine) Shows Clinical Benefit in Long-Term 48Week Phase 2 Extension Study in PDD
Study successfully achieved both primary and secondary objectives
ANAVEX®2-73 treatment resulted in improvements of all efficacy endpoints over 48 Weeks
Great to see