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Is this “good timing”?
Don't be too hard on him. He just found a way to argue against 85% odd of the approval and got excited a couple days ago.
I can't even imagine the disappointment just watching. lol
I hope that doesn’t happen to AVXL.
It now down to 88% up. Poor who bought in pre market at 700% down to 100%.
I bet you are hang on ..............here, Baked?
Or too busy enjoying your forever changed life. : )
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173049282
Let's dream on it.............maybe 0.0085% lol
What happened to your Acronyms for Bio-stock investments?
No moderators has pinned it or are you still on updating it?
Can a moderator pin it?
boi, Sorry for the trouble. 😄
I know you derived the number from the EMA data. You've been the advocate of 85% success. I also understand 15% chance of failure but we have more chance, a lot more chance. : )
Yes I DO agree. To simply put, can I say that we have the passed the preliminary review? Which means we have more chance to be approved for EMA than 1%.😄
Hosai, she seems to be very knowledgeable;I'm so impressed!
Thank you for your researching for the uncharted depths of our sails at this juncture.
I think these are where bio's 85% chance of an approval comes from; see the last paragraph: (underlined by me)
Hosai's question was for eligibility for submission of an application for a Union Marketing Authorisation in the EU. If the answer is trustworthy EMA has shown with substantial data to agree on the submission!
15 minutes are up, too late.
I'll need Anavex2-73 sooner or later. 😁
You will get used to it very quick. Using ihub app is very convenient giving your index finger a break. And faster browsing though it lacks certain functions like editing your message.
I like the ihub app on my phone more than on the tablet.
Investorshub certainly needs to promote them more.
I'm glad that's not my PC problem. iHub has been VERY slow today. Other sites seem ok. And ihub app on my iPad is ok. I tried a couple of things for Chrome without a success today. Hope they fix the problem soon.
110% up for only P2. : (
XBI up 4.68% now; IBB up 1.04%
Are you saying that my hoping pps ends at HOD a wishful thinking?
Just want to clarify.
You must have made tons of $$$!
Of course. Only if you have $100,000 aside for trading.
$5.20 A leap that we haven’t seen for a while. I hope we close at highest of the day. And leave the 52 week bottom behind.
$4.95(0.5%) Green we go!
Anavex today announced that it will present at the 44th Annual TD Cowen Health Care Conference, March 4-6, 2024.
Christopher U Missling, PhD, President & Chief Executive Officer will present the Company in a session scheduled at 1:30 PM (ET) on Monday, March 4th, 2024, at the Boston Marriott Copley Place in Boston, MA.
Thank you. Many thanks to MayoMobile,too.
Maybe he can put his works on SA for more exposure.
No worries(not toward to you) here.
5 years ago, pps was sub $2 in Jan 2019.
Bring the bottom and I will start over!
The difference is that we are much closer.
Yeah I'm getting weary for kindergarten talks on this board.
Thank you for your help.
Good for you! We stand where you stand; you didn't miss much of the show.
371 P2:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173856499
The most optimistic reward goes to you, CM. : ) Your best scenario helps little bit on these cloudy days. I try not to set my expectations on the peer review so high after seeing what happened for pediatric Rett trial. There's no grantees of "nothing short of very good and might be the best peer review ever seen for Alzheimer's".
Where did you hear that? Dr. Missling or from some posters?
What are the our best scenario and the worst scenario for that matter when what Anavex filed in November is not clear?
I'm asking you to write them up. : )
Review of Dr. Grimmer's interview by MayoMobile
AD/PD 2024 presentation on 3/9 in Lisbon, Portugal
Presenter: Timo Grimmer (Germany)
Lecture Time 09:10 - 09:25
Thanks to Veliger at Stocktwits.
$AVXL I'm hopeful the peer review may precede the 3/9 AD/PD Conference in Lisbon.
https://cslide.ctimeetingtech.com/adpd24/attendee/confcal/session/calendar?q=Anavex
Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine (ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed to exert neuroprotection through restoration of cellular homeostasis.
Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I, which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.
Results
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing treatment to placebo.
anavex_mri.jpg
Conclusions
Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and significantly slowed clinical progression at 48 weeks, which is also corroborated by biomarkers from the A/T/N spectrum, including plasma Aß42/40 ratio increase and reduction of brain atrophy in several key regions of the brain measured by MRI.
ClinicalTrials.gov Identifier: NCT03790709.
.
SRPT was down from $120 to $60(- 50%) for fail of a primary endpoint on 10/31/23; now 2 1/2 months after pps has recovered fully and up to $135 for an acceptance news by FDA yesterday below:
Despite a primary endpoint miss in a pivotal study, it looks like Sarepta’s dream is one step closer to coming true as the FDA accepted the company's efficacy supplement under a priority review.
ACHV was down from $5.5 to $3.3(- 40%) for a bad news in last Dec; now 2 months later pps has been crawling up to $4.4.
I am not comparing an apple to an apple but hoping for some positive developments dealing with the agencies by the end of 1Q.
.
Feb’ish. We’re in the second half of February. Hope we get somethin.
So, P2 for A371 will take a year. Maybe 1 1/2 year to get the result from now.
Thank you, georgejjl!
Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment in Part A and Part B.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)
Estimated Study Start Date : May 15, 2024
Estimated Primary Completion Date : May 15, 2025
Estimated Study Completion Date : May 15, 2025
IBB up 1%; AVXL down 2% it shucks.
Yes, sir really!
I got nothing. I remember a poster brought up an info a couple month ago.
I shall find and check myself.
It took almost 3 years for 12 week treatment of each patient. It's not gonna be a short trial then though it was during the Covid. : (
I can see that the previous participants in the trial would be disqualified. Thanks.
I got your point but Rett is rare disease and hard to recruit volunteers for the trial I assumed. I thought it's crucial for Dr. Missling to change the trial design for the success. Not the patients.
We probably keep the same locations and patients and it won't take too long to get ready.
Do you remember how long Excellence trial was?
Anyone who follows RS Group on FB knows the reactions/developments of the group since the PR on 1/2?
A high enrollment rate in the OLE of over 91% and the high level of requests for the Compassionate Use Program (93%) provide solid numerical evidence for the reported positive Real World Evidence (RWE) from patients with Rett syndrome under Compassionate Use Authorization. Families whose children were previously on drug or placebo in the placebo-controlled trial commented favorably on the improvement of their child’s daily life due to ANAVEX®2-73 treatment in the Compassionate Use Program.