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.
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.
How will the Alzheimer's Association and its members respond when they learn of these, blarcamesine's real clinical trial results?
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
Also the caregivers must be seeing improvement even after 4+ years. I would think positive input from family overseers would be a leading reason why participants are still receiving their daily dosage.
Who would poo poo stock they actually own. Hmm come to think of it with our upcoming EMA submission, shorts likely running on borrowed time
Ridiculous. New guidelines are for all further AD development not just Anavex. AD trial found stat-sig.
Ha. The trial having ADL as an outcome was improper and the FDA now recognizes this.
It's not that A-273 missed ADL, it's that ADL changes happen very slowly over time, which makes it very difficult to judge in a short span of time. The FDA recognizes this and no longer regards ADL as needed.
Based on a recent AARP article, It will cost medicare $3.5 billion to supply Leqembi next year. Since it's a hospital type infusion it has to go under Part B.
Now if this was an easy oral delivery such as Blarcamesine it would go under Part D prescription plan. A lot less troublesome and less expensive.
Agree. Ireland has a robust life sciences sector.
Yes according to the following- The facility must meet Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice
I would imagine Dr Missling would pick a manufacturer already on the EMA's approval list.
We have a good chance for approval. That's what matters.
No. Juneteenth has been set aside to commemorate the end of slavery in the united states. Its origins date back to June 19, 1865, when the Last group of people enslaved in the southern U.S. were informed of their freedom under the Emancipation Proclamation. President Abraham Lincoln had signed the Emancipation Proclamation more than two years earlier, on Jan. 1, 1863, declaring that everyone held as a slave was, and would continue to be, free.
As a side note- Texas has observed Junteenth since 1980.
Thanks in advance for approving Blarcamesine!
It's MAA, Marketing Authorization Application.
Add the fact that in parts of EU they do not have the required testing facilities that must be used with the MAB's.
It shows regulators are pressing hard to approve AD treatments. Oral Blarcamesine is effective, overall much safer than mabs.
Even after seeing brain swelling, brain bleeds and two deaths Lilly's Donanemab was 100% approved.
Correction- ADAS-Cog P = 0.0226
Bullish