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I think clearly from the CC the push back was due to the safety follow up and Missling pretty much as admitted Rett read out wouldn't be this year.
Soumit Roy
I see. And one last question on the Rett program. Could you give us a little color, when are you still expecting the data? Is it going to be before the year end 2023? And is there any delay or is it an expected safety window that you have follow-up that you have to -- you are doing which is why pushing the data back.
Christopher Missling
Yes, after the last 12-week readout, there was an additional safety follow-up and that's basically why the timing is maybe a little bit different from expectations, but we are on track to release this data once we have it.
Sounds as if they have the trial data but are now awaiting the final safety out come.
I see 3100 traded with 100000 at the ask.
edit- ihub currently showing 20000 traded
Many thanks for posting the Fox Business video. Good to hear Anavex mentioned.
Agree. Also saying the FDA has made a decision regarding A-273 would be a material event that the company would have had to release to the public.
The person may get caught but it's always after the fact and then it's too late.
I would think it's more to the line of private discussions.
AF gives you water to carry. Carry on.
Great find PJ!!
A fart is all he's got at this point.
Selling for capital tax loss could put one under wash sale rules. You'll need to wait 30 days to buy back same ticker. With news coming seems a risky move. My opinion.
Map covered with red and orange shows worrying spread of deadly fungus across the US
https://www.msn.com/en-us/health/medical/map-covered-with-red-and-orange-shows-worrying-spread-of-deadly-fungus-across-the-us/ar-AA1lDrYg
"Brilacidin’s ability to potentiate marketed antifungals, such as caspofungin, in multiple human pathogenic fungi, while showing strong stand-alone potency against the hard-to-treat fungal pathogen, C. neoformans, clearly supports Brilacidin’s potential to be developed as a novel antifungal".
Somebody wake up Leo
I think it's more to the fact that ihub sells a subscription for real time.
Where is it written that said peer review expected by year end?
Oh I'm quite sure it will gain approval. Thanks for your concerns though.
I will also sell some at new highs.
The low price over these last several months has given me time to accumulate. I consider myself fortunate.
It's all coming together-- "Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and
significantly slowed clinical progression at 48 weeks"
Several hit pieces drained investors money in 2015. Terrible what happened. God sees all.
Never wrong and when cornered ridicule.
Looking at clinicaltrials.com- Inputting NCT04314934 for OLE ANAVEX®2-73-AD-EP-004 takes you to OLE Phase 2b/3 Study ANAVEX2-73-AD-004 (ATTENTION-AD).
Are they not the same.
PR October 13, 2021-
About ANAVEX®2-73-AD-004 Clinical Study (ClinicalTrials.gov Identifier: NCT03790709) and OLE ANAVEX®2-73-AD-EP-004 Clinical Study ATTENTION-AD (ClinicalTrials.gov Identifier: NCT04314934)
Seems shorts are grasping at straws. EMA said go for full approval and the reasoning behind this is they liked what they saw nothing less. You don't get picked to play from a bad try out.
I see AH is $8.23. eom
The EMA saw the full data and requested they go for full approval. Sounds in the bag to me.
I'm a bit of an optimist.
Shorts just need to cover.
We now know the EMA has seen full results and that same body says go for full approval. Pretty hard to poopoo that finding. The public has not seen what the EMA has.
Phase 3 adult study was impressive, so now we wait pediatric study-
ANAVEX®2-73 (Blarcamesine) AVATAR Phase 3 Trial met Primary and Secondary Efficacy Endpoints
Primary and all secondary efficacy and safety endpoints met for the treatment of adult patients with Rett syndrome, with consistent improvements in RSBQ AUC (p = 0.037), ADAMS (p = 0.010) and CGI-I (p = 0.037) response
Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms with related changes in potential biomarkers (GABA and L-AAA) of disease pathology
Glad I added this morning. $8 on tap.
Yes I misspoke were not directly funding the company but supporting it's operations through share ownership. Thanks for clarity.
Yes and I plan to keep holding a portion.
Ha. My wife now receives the emails. Very much loves that this drug can be a god-send to these families. We can all say we helped in the endeavor with our funding.
But the company is applying for EU approval next look for Australia. I bet sava wish they could.
On track in first gear.
From todays press release- "Rett syndrome: On track for top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial". The company has reported many times that Rett data this year.
"Ahead of commercial rollout in 2025, the company wishes to bring on board a young, talented and ambitious operational specialist to lead rollout planning, transfer to manufacturing, procurement, and full project management".
From Linkedin. Good to see.
https://www.linkedin.com/jobs/view/3765405108/?refId=UORlp1odWwWXz5zkxMf4Jw%3D%3D
Hoping if they are backing away on the enema research it is because of interest in the time release pill. I think the pill over time could make the enema treatment obsolete.
So did you pay?
Caspofungin, voriconazole and posaconazole anti-fungal activity can "potentiate" (increase effect) when added with Brilacidin.
"Previous research conducted primarily by scientists at the University of São Paulo (USP), Brazil, showed Brilacidin can potentiate several marketed antifungals, including caspofungin, voriconazole and posaconazole. Moreover, Brilacidin exhibited potent stand-alone efficacy (MIC=2.5µM) against C. neoformans – a deadly fungus that causes an estimated 220,000 cases of cryptococcal meningitis worldwide each year and for which few effective treatments exist".
http://www.ipharminc.com/press-release/2022/12/13/innovation-pharmaceuticals-reports-new-in-vivo-antifungal-data-showing-brilacidins-potential-for-treating-fungal-keratitis?rq=caspofungin%20
Reverse Rett presents the 14th Annual Reverse Rett London Gala, which is proudly sponsored by Core Marketing, Anavex Life Sciences, Blackridge Communications and KDW Financial Planning, is to be held on 10th November 2023 at the Royal College of Physicians, Regent’s Park, London.
Hmm short covering.. Go AVXL
And then there's the data - "Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows Neurodegeneration"