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Nice frenchbroad! sum sum summertime..
I get it that the ones who benefited the most were the parents. Kind of a euphoria I suppose.
Dr Missling needs to produce the very long awaited phase 2b/3 data to the rest of the world and tell us the plan. It better be as good as what was insinuated during the cc.
Sorry, I should have referenced in my response that I meant A-2-73 phase 2b/3 study was stat sig.
Yep. TLR stat sig and the short bears went nuclear.
Cheap shot.
Yes. Topline data results are expected in January 2024.
BeaMed's co-owner
https://www.neo-laser.com
1500 systems placed
40 countries
200,000 surgeries performed
Nice accumulation. https://www.beam-med.com/#about Copyright 2024-BeaMed
In the last cc Missling said we will present the data once it's available. So saying he just had it laying around I believe is a stretch.
Yes the videos are the ones from 5 years ago but all the same it showed they improved greatly in their cognizant ability also motor function taking A-273. While the videos show it improves lives it's still not the fountain of youth. Having improved quality of life is a good goal.
When looking at other placebo-controlled Rett syndrome trials, ANAVEX®2-73 compares favorably in terms of absolute RSBQ improvements, with the caveat that cross trials comparisons have their limitations.
The key secondary endpoint, the Anxiety, Depression, and Mood Scale (ADAMS), trended favorably. In the same analysis, scores for all RSBQ and ADAMS subscales improved over the course of the study. Collectively, the RSBQ and ADAMS demonstrated improvements in multiple areas, impacting positively in particular repetitive movements, nighttime disruptive behaviors and social avoidance.
Nothing on seizures yet but we do know from the videos two children had pretty much stopped having seizure according to their parents. Really would like to know more on RWE. Canadian patients asked for compassionate use for a reason.
! Thanks
I would think with so few options available for Rett children, a reduction in seizures would be a cause for approval.
A-273 RSBQ scored much better.
Wouldn't they discuss combining successful results of adult women study and pediatric outcomes with FDA for approval..
Dr Missling "the timing is maybe a little bit different from expectations" His statement doesn't sound like it will be a long wait.
Whoa, the bears are active this morning. Happy 2024.
Hmm how many effective CNS drugs have you brought from trial to market? Just asking. Watch the videos that should make you smile. Rett is darn close.
Oh you care. Other wise be no need to always poo poo good news.
Altruism or concerned over a short position getting vaporized.
I see you make it up as you go. Could be private by invitation only, oh yes thats what it says.
I know you've been saying this for years and yes there was some reported elevated blood pressures it was only a few patients. At this point for me it's not worth the argument. You have at it. Seems B is in retirement at this point anyway.
Common side effects of daptomycin may include:
chest pain, trouble breathing;
headache, dizziness;
stomach pain, vomiting;
swelling;
abnormal liver function tests;
rash, itching, sweating;
trouble sleeping;
sore throat; or
increased blood pressure.
Patients treated in the P2/b ABSSSI trial were healed of their acute bacterial skin and skin structure infections. There's proof that B is effective in humans but Leo dropped the ball with it.
Like on a hamster wheel. Always spinning.
Longs have a very promising compound ready to take the world stage. Those Rett videos are eye opening, just hearing the parents saying their child went from many seizures to none. Wow.
I was out of this stock for several years feel very fortunate to be back in.
Concerned over a short position are we.. day of reckoning is coming.
You probably look at a painting too close? Anavex and co. has accomplished a great deal when you just step back and admire the whole picture.
Excellent. A lot of promise wrapped up in that little pill.
I put most of the blame on the CRO. I do think Missling needs to engage with them more in making sure timelines are being met.
We don't know when it will be released. Missling made it clear during the Q&A that he didn't yet have the data.
After washout period and then from baseline it shows PDD symptoms decreasing. Thanks.
Anavex contracts out their trial research along with that most corporate control. I believe Anavex is given a best time estimate of a certain quarter which are then passed onto shareholders. Yes clinical trials have a propensity to slip and I think even today the covid shutdown is still having some negative effects.
Anavex didn't wait a year before making a decision to meet EMA, we recently learned they had several discussions with the EMA and if that governmental organization is anything like the pace of the FDA those meetings took several months.
Dr Missling absolutely knows the phase2/3 full data and so does the EMA. Now would Dr Missling submit a failed Alz trial to be printed in a prestigious peer review, heck no.
Instead of just spinning reality read the CC transcripts, TLR will not be released until after all safety checks are completed. Date got pushed back.
lol I just checked yesterday. I guess B's now sitting on the shelf with the elf.
TLR that says All children that had seizures now reporting greatly reduced to no longer having seizures. We saw a sample of two from the study and likely be others out of 92 participants.
Press release still stands. Thanks for pointing that out.
Posted on Yahoo Finance-
Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA
Zacks Equity Research
Wed, December 20, 2023 at 11:09 AM EST
Anavex Life Sciences Corp. AVXL announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) considers its pipeline candidate, oral blarcamesine, eligible for a centralized regulatory review in the EU.
This indicates that Anavex may file a single marketing application to the European Medicines Agency. The company initiated the regulatory submission of blarcamesine for the treatment of Alzheimer’s disease to the EMA in November 2023.
The marketing authorization application, upon potential approval, will grant the company direct access to the European Union market. Anavex is planning to submit a marketing authorization application for blarcamesine at the earliest possible date in 2024.
Shares of the Anavex were up 13.2% on Dec 19 following the announcement of the news. The stock has rallied 15.6% in the past year against the industry’s decline of 19.6%.
Per the company, blarcamesine is being evaluated in a IIb/III clinical study for Alzheimer's disease. Besides showing significant improvement in dementia symptoms in the study, treatment with blarcamesine also led to a reduction in pathological aggregation of amyloid in early Alzheimer’s disease and reduced brain volume loss, a renowned marker of neurodegeneration.
Anavex’s orally administered blarcamesine is an easier-to-use formulation. The oral treatment does not require complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Anavex is also evaluating blarcamesine in several other central nervous system indications. The candidate is being developed in mid-to-late-stage studies for treating Rett syndrome, Parkinson's disease, schizophrenia, Fragile X and other rare diseases.
Zacks Rank & Other Stocks to Consider
Anavex currently carries a Zacks Rank #2 (Buy).