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Hmm, Anavex hasn't mentioned enzymes. They have mentioned there drug prevents misfolding of amyloid protein, but amyloid is not an enzyme. Are you trying to say enzyme's can be incorrectly "packaged", or folded, resulting their dysfunction which leads to certain diseases? Which enzymes and which diseases is this an issue for?
Regarding Alzheimers, if misfolded amyloid causes symptoms, you'd think the Lilly drug and the other immunoglobulin drugs reducing amyloid would be more helpful.
Does a faulty endoplasmic reticulum cause other problems possibly leading to dementia besides just producing misfolded amyloid?
So you are inferring that the drug in this trial is only slowing the rate of decline a couple points above the decline shown by historical control groups of Alzheimers patients. But doesn't that conflict with the PR which says 41 week stabilization in MMSE, ADCS ADL, and every other measured indice measured in the trial?
Because 5 week data was presented at a CTAD (most prestigious) oral presentation (not just a poster). CTAD oral presentation = max visibility for Anavex and the trial. If McFarlane makes the long flight to attend a conference, it's gonna be for the prestige conference of the year (CTAD), especially if trial results will be given in an oral presentation. I've read CTAD is the premier biotech event of this year period. It is like going to the AMA's versus going to the Grammy Awards, or Golden Globes vs the Oscars. Stars might skip the AMA and Golden Globes but not the main events of the year (Grammy's and Oscar's). Before CTAD last year, the scuttlebutt was that McFarlane would be attending so that must indicate good results, otherwise Anavex wouldn't bother flying him across the globe for several days just for crap results. The results were indeed good, so maybe there's *some* truth to that. IDK.
Yeah, me too, but it took forever to load and I could't access anything once there
The 6 mo data was just a poster presentation. McFarlane maybe comes just for CTAD b/c it is biggest Alzheimers conference and b/c Anavex gives oral presentations there. And lots to present this time. Tail end of the study, it is complete. He prolly wants to make appearance so other biotechs, investors, possible partners know who will be heading up PH 3 in Australia as well as the current study.
Anavex has what, 8 employees? They're too busy to be cranking out PR's on stuff that isn't significant. Each PR takes a lot of time to put together so that it is acccurate and can't be miscontrued. They can't just be drafted in 5'
Opiods are bad for reasons other than they are addictive and can be abused. They have lots of side affects: constipation, sleepiness, affect mood, driving is difficult on them, overdose, combining with alcohol and other meds can be problem, tolerance so then need to take more and more, no anti inflammatory affect, etc
Very true. The $ in politics is the root of all that is wrong with govt, especially at the federal level where there is so much $ to be made. We need a Constitutional amendment addressing campaign finance, lobbying, and the revolving door.
I just hope if Anavex ever does take off it will be before we're all old or dead. The wheels turn so slowly
How you know Anavex's pipeline is any better than the other sigma 1 drugs, dextromethorphan for example?
Does the downward trajectory of the AAIC results cause you concern? Missling said Sigma-1 drugs have a huge affect right after patients go on them, but we didn't see that in the trial. No dramatic spike up like we even see to some extent right off the bat with donepezil during first month and second
If Anavex 273 ever does get approved, it will have lots of competition in the pharmacy and clinics
Have you bothered to look at the trajectory of the trial results from AAIC last July? Your predictions are way too optimistic imho. When sky high expectations aren't met, even when results are OK, investors hit the panic button. I don't think it helps AVXL to set such very high, unprecedented expectations.
From Anavex's AAIC poster summary:
"Despite the relatively small sample size of this proof-of-concept,
randomized, open-label study with oral daily doses (not optimized) of
ANAVEX 2-73 ranging from 10mg to 50mg, data seems to indicate a
converging and consistent response for all measurements (MMSE,
ADCS-ADL, Cogstate, EEG/ERP) currently throughout 31 weeks (7
months) of ANAVEX 2-73 treatment."
As the quote above states, the patients have been on NON-OPTIMIZED dosages of 10-50mg. Imagine how much better their scores would be had they all been receiving 50mg every day from day one of Ph 2. Imagine how much better their scores would be had 273 not been having to compete for receptor sites with already spent donepezil. Donepezil has MUCH greater affinity for the sigma sites and its effect on the muscarinic sites is the exact opposite effect as 273. A paper posted here couple months ago showed muscarinic antagonists, like donepezil, actually thwart, counter, and dampen the beneficial effects of muscarinic agonists, such as 273. If anyone has link to that paper please post here.
My point is, don't expect improvement or stabilization of scores at 9 or 12 months at CTAD. That's now fair to 273. Be realistic and logical. Ignore the non scientists that don't take the aforementioned into account.
Anavex's team is very small. I'm sure Missling is very busy. I want him focused on the important things. If we keep hounding him to do this and do that, he'd never have time to get to the important stuff that needs to get done. He's already overburdened as it is.
Which indicator(s) make you think this is gonna drop below support at $2.41?
I think avxl has yet to hit its 1 year low in the 2.4-2.5 range before CTAD. I assume you assume that the manipulators use tech analysis to dictate their manipulation?
That's just not realistic even under the best of circumstances
The article said the drug targets inflammation and has a novel MOA. They're getting a lot of $ to proceed with Ph 1
The patients and their caregivers aren't idiots. They see the results of the 273 solo patients and you can bet they're gonna want to ditch donepezil.
Such as partnering for Alzheimers now to get Ph 3 rolling and waiting to partner for other indications (MS after testing is done)?
If AVXL has same or slightly less efficacy than soc for AD, 273 still get approved so those intolerant of soc have an alternative, or 273 as an alternative to take once soc's beneficial effect has plateaued?
What do you believe is the best price to cover at tomorrow (for those that didn't today)?
When negative posts ramp up on mb's sans *LEGIT* negative news, that is my cue that a stock is being brought down before covering takes place. Good buying opportunity at the bottom before the covering begins. If negative mb sentiment coincides with one or more negative stories on SA, MF, The St, etc, then an especially good buying opportunity is in store.
This 30' video is on ALS and the effort to get access to experimental drugs still in development. The second half of the video gets into that more.
Why you think Biogen asked for 273? Hmmm. B/C they want to play with it and check it out and verify some things before they sign on the dotted line. Biogen is a pharmaceutical co focused on neuro drugs just like anavex. Biogen is struggling. Aducanumab causes brain swelling and they are like a nfl football team in need of a free agent signing to keep them competitive.
If Anavex's Ph 2 trial looked to be disappointing to the FDA, they would let Anavex know they have concerns about Anavex doing a Ph 3 trial. If that were the case, Anavex would not keep confidantly stating over and over they are moving forward onto Ph 3.
Company didn't state that. I deduced that based on trial results and biochemistry. Anavex has been in communication with FDA for long time now about the trial and designing Phase III. If results were @#$%, I'm assuming FDA would have told Anavex that and dampened there plans to move so quickly to Ph III.
By "mediocre" data are you referring to efficacy, a secondary endpoint of the trial btw? I'm gonna assume you were. Why did you expect cure or stabilization at 31 weeks when doses aren't optimized and donepezil has a counteracting affect on 2-73? Actually, the seven 273 montherapy patients showed stable mmse and adcs adl, in fact the mmse went up 3+ points at 31 weeks. The Part A of Phase 2A involved on-off dosing with differing dosages and 12 days off 273. Keep your expectations realistic. Only traders of AVXL found the 31 week results mediocre or poor. Scientists, Anavex, Biogen, and FDA found results promising given the trial's exploratory design.
Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, commented: “To interpret the ANAVEX 2-73 results presented at the 2016 AAIC meeting, it is important to keep in mind the stated goals of this first in Alzheimer’s patients study. This was a Phase 2a study, primarily designed to determine which ANAVEX 2-73 dosages are safe to administer to mild to moderate stage Alzheimer’s patients. The study was successful in establishing the maximum tolerated dose and in revealing the range of ANAVEX 2-73 doses that are well-tolerated by Alzheimer patients. It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. However, this analysis was based on pooled data from a relatively small number of subjects receiving a variety of doses. It is therefore unlikely that these findings reflect the full potential ANAVEX 2-73 in treating Alzheimer’s disease. It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”
I just don't know if that bar can met for this trial design. If any patients are on 50mg/day 273 monotherapy, they have the best shot imo. Actually, the 7 on 273 monotherapy have been pretty stable through 31 weeks. I don't know what dosages they are on. Most donepezil trials show its mmse scores dropping after 3-6 months and sinking below baseline just after 6 months. 273 does have one important advantage over donepezil, it is much better tolerated.
What would constitute favorable efficacy for 273+ and/or 273?
Have all the trial's participants been on daily 50mg of 273 since the end of Ph 2a, Part a?
Traders would benefit from doing DD, studying the science of the drug, put in the hours, read all the PR's going back in time multiple times. Don't just rely on TA and what AF tweeted (although, I do have the utmost respect for scientists such as AF and his "expert" Dr friend that moved to europe to do pc tech support for $10/hr). Prove what I said is wrong. Back it up. Missling said patients are on 10-50mg dosings at least thru 31 weeks at Lartenburg and, I believe, in the summary of the poster from AAIC. Look at DZP's affect on the TauRX drug, not just how it is stymying 273. It competes for sigma and muscarinic receptors and has much greater affinity to boot. Knowledge is power.
This is not true. Missling said at Lartenburg, as well as the AAIC poster summary, that dosings are still 10-50mg through at least 31 weeks. clinicaltrials.gov said last month only 25% of subjects are on 50mg.
DZP stymies 273 I am convinced. Just look at the 7 only on 273 vs 273+dzp scores. DZP competitively competes with 273 for sigma sites and it has MUCH greater affinity for those sites than 273. DZP counters 273's agonism of the M1 receptor b/c it is a M1 antagonist. A paper even wrote that M1 antagonists cancel out drugs that agonize M1. Look at DZP's affect on TauRx's drug permformance, which targets M1. It cancels out TauRx's drug.
Remember though, maybe only 1/3 or 1/4 have been on 50mg. And, most the subjects are also taking donepezil, which counteracts 273
It is actually spelled Capiak. From last Nov. 25th's Anavex PR:
Kristina M. Capiak, CCRP has been promoted the Company’s Vice President of Regulatory Affairs. She is overseeing U.S. and international regulatory matters for Anavex, including filings and interactions with the FDA and other regulatory authorities.
“We are excited to expand Ms. Capiak’s role to oversee the Company’s clinical development programs and other indications given Ms. Capiak’s expertise and we are delighted to have her on our team,” said Dr. Christopher U. Missling, PhD, President and Chief Executive Officer for Anavex.
Ms. Capiak has more than 10 years of academic clinical research and healthcare industry experience within the biotech industry. Prior to joining Anavex, Ms. Capiak was the Global Regulatory Lead at Retrophin, Inc. where she implemented U.S. and EU strategy for the ongoing development programs, which received orphan drug designations as well as fast track designation. At Regeneron Pharmaceuticals Ms. Capiak was on the pharmacovigilance and risk management team where she analyzed the ongoing safety events for the pipeline of development products and for EYLEA®.
Ms. Capiak’s background also includes clinical trial staffing and oversight for more than 60 clinical trials at both Columbia University Medical Center, where she co-authored several papers, and Memorial Sloan-Kettering Cancer Center, where she became a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates.
While an undergraduate, Ms. Capiak participated in translational medical research at the University of Michigan Medical School through the Undergraduate Research Opportunity Program. She is a graduate of both the University of Michigan and New York City’s Columbia University.
A toxoid is a chemically modified toxin from a pathogenic microorganism, which is no longer toxic but is still antigenic (ie recognized as foreign by body thus initiating an immune response which involves making antibodies against the antigen) and can be used as a vaccine.
So, what do toxoids have to do with Anavex? Maybe Anavex drugs given to prevent or reverse any adverse event or condition occurring from toxoid exposure? IDK
I wonder if Biogen, as a condition of partnership(s), requested Anavex collaborate with Ariana and lend Biogen some 273 to test. If 273 checks out OK in their lab and Biogen likes the PK, updated results, and stats from Ariana, then partnership will happen?
The truth is biotech is all about the scientific potential of a company's pipeline. Most retail "investors" and traders do damn little DD on the company's compounds. Don't even go to the company's website and read the news releases and publications. They don't know squat about biology, biochem, pharmacology, physiology, anatomy, etc. So, they are ignorant and thus susceptible to falling prey to the BS put out by Adam Feuerstein, Jean Fontenewww, and the other hedge fund mouthpieces. Even if I believed Feuerstein was sincere, which I do not for one second, why would I listen to him talking about the science of drugs or drug trial results and design? He has a lib arts degree and has been nothing more than a biotech pundit as of late. Feuerstein cited a Dr's opinion on 273 last year. That Dr didn't break down the science, just compared it to being as effective as coffee for treating Alzheimers. That noname "Dr" hasn't practiced medicine in years and is working in Europe doing PC repair and tech support for $10/hr. And that is Feuerstein's "go to" medical "expert". Please. Probably some guy with a MD that is broke, strung out on drugs that the hedge funds could pay to spew BS.