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For one thing you don't know what your talking about. Amazon pill pack is huge, meds are delivered presorted.
https://www.pillpack.com/
Well if they are all so much better what are you here??
"Further investigations involving drug combinations identified five synergistic drug combinations"
"Regards to time-kill and biofilm assays, the combinations of MUT056399 and brilacidin or eravacycline will be selected for the efficacy test in the chronic wound infection mice model."
Wow now FIVE synergistic drug combination also Cronic wound infection is certainly new.
This from John Hopkins-
"A study that tracked the mental functioning and multivitamin use of 5,947 men for 12 years found that multivitamins did not reduce risk for mental declines such as memory loss or slowed-down thinking"
The Vitamin Verdict-
"The researchers concluded that multivitamins don’t reduce the risk for heart disease, cancer, cognitive decline (such as memory loss and slowed-down thinking) or an early death. They also noted that in prior studies, vitamin E and beta-carotene supplements appear to be harmful, especially at high doses."
https://www.hopkinsmedicine.org/health/wellness-and-prevention/is-there-really-any-benefit-to-multivitamins
What we have even with the flurry approvals is Alzheimer's disease is still a cause of major irreversible morbidity that's not being addressed adequately. A-273 has shown to improve cognition, improve REM sleep and even slow brain atrophy. The need is great.
So the astounding 83% final approval rate is mainly due to those early EMA meetings who's purpose is to weed out inferior candidates. If so we are in good shape.
Feels like the last scene from Perfect Storm..
https://video.search.yahoo.com/search/video?fr=yfp-t-s&ei=UTF-8&p=last+scene+in+perfect+storm+movie#id=1&vid=26f9c9cbcdd944af6970699e0164d95f&action=click
MAA on subset. I think this bodes well for Anavex.
If Leo pays the 1.4million to get his preferred shares out of lien could it be safe to say the deal with Gil is still on.
The peer review will lean toward the scientific community including Big Pharma who's looking to partner
He also said they met several times. Reporting the EMA Requested them to apply for Full approval is just not something you would say publicly if it didn't happen. You think no one else within the company is involved in these discussions. smh
- Slows neurodegeneration
- Significant slowing of brain atrophy
- Orally-administered for Ease of use
- Good Safety profile
- Requested to file for full EMA approval
- MABs told need not apply
So not only is Dr Missling applying for approval but for full approval. The need is great
I guess they are just not on board with new innovative ideas. Old school meet re-education..
This jumped out at me. Posted 9-6
THE UNFORTUNATE STORY OF CASSAVA SCIENCES
The other news I want to highlight is more discouraging. You may be aware of Cassava Sciences, whose sole products are a drug, simufilam, and a diagnostic blood test, SavaDx. The company’s core hypothesis is that when filamin-A changes its conformation, it triggers amyloid deposition, synaptic dysfunction and tau phosphorylation. The hypothesis is essentially unique to the company and its scientific founders, and the underlying science long has been challenged by the rest of the field as unable to be replicated by other labs and as inconsistent with other scientific data. In recent years, scientific sleuths and financial whistleblowers have accused the early publications supporting Cassava’s hypothesis of image manipulation, and Cassava’s clinical trials have been assailed for failing to follow generally accepted practices for statistical and scientific integrity. Recently, the lead scientist on the studies that led to the development of simufilam and SavaDx, Dr. Hoau-Yan Wang, was indicted by a federal grand jury for falsifying data to fraudulently obtain NIH grants on his own and on the company’s behalf. Although Cassava points out that
Dr. Wang had no part in designing the ongoing phase 3 clinical trial of simufilam, the data he allegedly falsified is the foundation of what justified the trial at all. The company’s board then announced the U.S. Department of Justice and the U.S. Securities and Exchange Commission had launched an investigation into two senior executives; Cassava’s CEO and SVP of Neuroscience both resigned shortly thereafter.
While the moral of this story may be that scientific bad actors do eventually get caught, the costs—to the trial participants and their caregivers, to the better scientific possibilities that lost out in funding and attention as Cassava made its loud public claims, to taxpayers and investors and their trust in the scientific community—are immense. Thanks to thoughtful input from our RLG, CureAlz never joined the Cassava bandwagon, but this incident reminds us to be just as aggressive in our smart skepticism about innovative and unexpected ideas and approaches as we are enthusiastic about recruiting them.
https://curealz.org/news-and-events/updates-and-insights-from-our-ceo/
This would speed up approval timeline-
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
There's no guarantee of waking up in the morning. Anavex will likely file for EMA approval, remember they already met with the EMA several times. I like our chances.
"Mutual Recognition Agreements (MRAs) between FDA and foreign regulatory authorities allow drug inspectors to rely upon information from drug inspections conducted within each other’s borders".
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra
Foreign studies require no FDA input. Btw the studies are not flawed as you accuse.
I trust the results which are backed up by Dr Jin, Lead Neurology Statistician. Blarcamesine shines as an AD treatment compared to MaB infusions.. Looking forward to EMA filing..
You said you wouldn't be back till it hits below $3 lol... Welcome back though!
Your facts are fiction. You may want to get the pipeline straight.
Possibly could command more, but I think for access in European healthcare it needs to be priced equitably. In the end It will come down to R&D, manufacturing and distribution costs.
No doubt a safe, effective oral AD drug that reduces brain shrinkage, promotes better sleep and priced around $800 monthly would be quite attractive to EU regulators. 4 million scripts,, $38.4 Billion in EU
A completed EMA filing will make this a red letter year.
So MAA submission October/November time frame.
NeurologyLive’s Post
View organization page for NeurologyLive, graphic
NeurologyLive
Dr Marwan Sabbagh
12,474 followers
1d
Newly presented data from a phase 2b/3 study of patients with early-stage Alzheimer disease showed that treatment with blarcamesine (Anavex Life Sciences) was safe, with no associated neuroimaging adverse events, and resulted in significant slowed clinical decline on several notable end points. Based on the totality of the data, the company intends a full regulatory submission of blarcamesine in Europe in Q4 of 2024.
https://www.linkedin.com/posts/neurology-live_blarcamesine-shows-significant-slowing-of-activity-7228130553357570048-Hi67/?utm_source=share&utm_medium=member_desktop
Why wouldn't dropouts have been included in the full data sent to EMA? Full data was sent some 6 months after top line data.
If the OLE study proves night dosing and slower titration helps mitigate dizziness, this should go a long way to further strengthen Misslings case and approval.
During the Q3 call, Dr Missling did report the OLE last patient last visit was completed in June, then went on to say interim data is expected in the second half of 2024. By the wording, Dr Missling et al. are waiting for those results. I too am wondering why Dr Missling didn't toot his horn louder or be more excited of upcoming interim. Not surprised though he's generally vague about most things.
You mean like welcome to the dark side. lol
Per the presser- "Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical trial of ANAVEX®3-71 for the treatment of schizophrenia has completed dosing of the first cohort and is nearing the completion of enrollment of the second cohort of schizophrenia patients in Part A of the trial."
Missling said in the Q3 call Aug 6 that the clinical team continues to beat planned timelines of A-371 in schizophrenia patients. Good to hear.
"Anavex Life Sciences intends to submit a full regulatory application for blarcamesine as a potential treatment for AD in Europe by Q4 2024." By Q4? I take that as even before Q4.
https://www.neurologylive.com/view/blarcamesine-shows-significant-slowing-alzheimer-disease-phase-2-3-trial
"Oral drug Blarcamesine demonstrated superior clinical safety and efficacy
compared to mAb Leqembi (Lecanemab) and mAb Donanemab and slows
neurodegeneration in Early Alzheimer’s Disease" -Slide 5
https://www.anavex.com/_files/ugd/79bcf7_34621a802cb94006ba8b91012327d541.pdf
The need is great
Funny thing is that I take a drug that controls irregular heartbeats and one of the side effects is irregular heartbeats.
The approved competition are brain bleed killers. The need is great.
New Chemical Entity Exclusivity (NCE) – adds 5 years
Large closing buy - 102,721 shares
"Very little progress" "No concrete evidence" are you for real. Maybe you should think about hitting delete before hitting send.
The rare CNS disease could be this. Only 350 cases per year in the US- https://www.ninds.nih.gov/health-information/disorders/creutzfeldt-jakob-disease#:~:text=Creutzfeldt-Jakob%20disease%20%28CJD%29%20is%20a%20rare%2C%20rapidly%20worsening,about%20350%20cases%20per%20year%20in%20the%20U.S.
After further reading I changed my conclusion. This disease is also transmittable.
Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024, 8:30 am ET