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Just to keep this topic warm, I'd like to add an excerpt from the Q3 transcript...
"Lastly, a recent third-party peer reviewed scientific publication titled Neuronal Sigma-1 Receptor signaling functions and protective roles in neurodegenerative diseases, details the mechanism of action of sigma-1 receptor, S1R and references ANAVEX 2-73 among the relevant sigma-1 receptor ligands.
The paper summarizes, in conclusion, sigma-1 receptor is incredibly versatile in its ability to foster neuronal homeostasis in the context of several neurodegenerative disorders. We believe that this comment is a confirmation that Anavex is on the right track pursuing this very promising therapeutic approach for targeting patients with devastating rare diseases as well as the largest unmet medical need of aging population, which is Alzheimer’s disease and Parkinson’s disease."
Sure seems to me like the company sometimes comments on articles from third parties.
Alan,
I just wanted to remind everyone of something else that's sitting on the backburner. Yes, the dates are a bit stale, but not the concept. Which deal will come next ??
"Brilacidin—Dermatology Formulation Development
Brilacidin has successfully completed Phase 2 trials in Oral Mucositis (OM), Inflammatory Bowel Disease (IBD) and Acute Bacterial Skin and Structure Infection (ABSSSI). A drug with broad platform potential (pdf), Brilacidin’s innate properties and modes of action, as well as additional pre-clinical work, support the drug’s potential for topical application in dermatology, including: Atopic Dermatitis, Acne, and Hidradenitis Suppurativa. All are areas of large unmet need and comprise highly lucrative markets.
To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets. The formulator brings an impressive track record of developing products that have earned billions of dollars for global pharmaceutical companies.
For a discussion on Brilacidin’s potential as a topical agent in dermatology, please read more at the following link:
“Brilacidin’s Potential Application in Dermatology”
Lol, I almost spit out my drink ??
No problem. Just want to make sure we are on the same page.
The quote I gave you said we were past the expected enrollment date
Nothing that I sent would suggest they are running behind and that's not my point. The "3 week" dosing, Part A, and guaranteed dosing do not exist in the record.
The "Part A" seems to suggest we are doing more than one "Part".
Anyone else find this confusing? Why 3 weeks, why "part A" and why guaranteed to get the drug?
from clinicaltrials.gov "This is a 7-week placebo-controlled study of ANAVEX2-73 "
So, I personally don't think we are 1 patient away from full enrollment. To me, it reads as if there is a preliminary (exploratory?) group that is being tested for 3 weeks.
Anyone else care to weigh in?
I certainly like these kinds of posts. They force me to do research and learn new things .
No trying to burst a bubble here, but I found the same language in the 2017 s-3 filing:
https://ih.advfn.com/stock-market/NASDAQ/anavex-life-sciences-corp-AVXL/stock-news/74753140/securities-registration-statement-simplified-form
So I'm having trouble understanding how the science is junk. Why would someone partner with IPIX? Was the conclusion in your post completely wrong?
No, you said there would be no deal for IPIX. You should read the PR from this morning. IPIX got a deal.
I think this post was completely wrong too. Nothing pro about it.
Wow, talk about getting it totally and completely wrong. I mean like epically wrong.
Thanks for the laugh. If I were CEO with grand news coming, I would:
Secure preferred shares
Secure operation funding commitments through Lincoln
Proactively register a shelf for for future growth
But I guess we are each able to only see as far as our intellect will allow. Best of luck
I just want to highlight some obvious observations and speculate where we might be right now.
In the 2a trial, it was a single indication, limited patients. Right now, there are 3 trials ongoing, many multiples of patients, with several separate indications. Anavex's thesis is if you activate sigmar 1, the body heals itself of anything under the umbrella of sigmar 1. Also, recall that the biomarkers identified are drug specific, not indication specific.
A reason why the company might be quiet right now is they may be proving that thesis. If 2 or all 3 of the trials are providing concurrent data to support that thesis, then it could be inferred to work on all indications within the scope of sigmar 1. That would incredibly profound. I would be quiet about that too until I had all my i's dotted, t's crossed.
Carry on
Corporate presentation hasn't been updated from April either...
Even if blood pressure isn't a primary or secondary endpoint for the current trials, I would bet you anything - every single patient will have blood pressure readings taken. It is standard practice. If they notice blood pressure readings improving, that seems like compelling information to start a trial for that indication.
I was intentionally being vague. I believe one of the future milestones noted this and a summary from the annual shareholder's meeting mentioned it. When I just looked at the current slide deck it reads more as an new indication will be selected by year end, not sure if the trial will have been kicked off by then...
But, also, which drug 3-71 or 2-73? Seems prudent to diversify and develop 3-71 at this point...
But, Missling is getting real data from patients treated with 2-73. If he learns of significant diabetes or blood pressure or sleep improvement, hmmm... well then decisions, decisions. Which is the biggest market, which is the most cost effective trial, which has the most secure patent protection, which has the least competition...
I think this is prudent. Company says it wants to initiate a trial for a new indication before year end. My thoughts are something material will happen first, which will increase share price and then will tap the Lincoln financing for that new trial using substantially fewer shares.
I think what will be most interesting is: which indication?
I think what the company can see is data in AGGREGATE. The trial data is blinded and randomized and the company cannot see it. Instead they receive data reported such as SAEs and other information, but don't know if the individual patients are receiving medium, high or placebo.
For example, if they get aggregate data that says 1/3 of patients improved, it would suggest A 2-73 is working but could not rule out the placebo arm, hence it's not conclusive until unblinding.
However, if the aggregate data says 2/3 of patients are improving, then the company can certainly infer that A 2-73 is working, they just wouldn't know which arm, medium or high or both.
What's interesting is that since the indications already in trials don't go through spontaneous remission (like you might get with psoriasis or cancer), it's probably much easier and more accurate for the company to draw conclusions from the blinded data... i.e. you are not expected to improve with a parkinson's diagnosis, so even if only 1/3 of patients improve while data is still blinded, it is more than likely the drug that is causing the effect.
I just want to weight in... I think you two are only talking about the ALZ symptoms...but shouldn't some of the patients pass just from other natural causes...?
Since sigma 1 is throughout the body, I'm wondering if the patients are seeing other (maybe heart?) improvements. What if their ALZ has stabilized... but other health metrics are stabilized or improving too?!
Thoughts? Maybe this is going to be covered in the next publication?
CHECK IT OUT!
This page looks like it recently got updated...
EVENTS
I concur with Karin's post, I think it was clearly spelled out.
Wow, that's the best argument against today's news? Seems a little limp, maybe completely impotent.
does include the mouth?
If you are correct, then this also leads me to another observation: AVXL has been managing approximately 2 YEARS cash on hand (~20+ million). And now all of a sudden, they let that drop to 18 months? Missling has been very prudent (and very smart) over the past several years to keep a safe amount of cash and now it drops to 18 months....! 18 months when our demands for cash are increasing...?
Am I the only one that sees the silver lining in the decrease in cash on hand? Does the expansion in the trials to AUS and the reduced cash base point toward the same outcome? ... Namely a much shorter timeline until some significant event...
Question to the board - I'm trying to be specific here...
Known: AVXL is starting up PDD and Rett in Australia. Enrollment for PDD is churning along at a good clip already in Spain...Rett's patients in US are on speed dial and ONLY 15 patients needed.
WHY NOT WAIT A COUPLE MORE MONTHS, GET RESULTS AND THEN EXPAND TO AUS?
I don't buy that PDD needs more sites. Also Rett is exploratory efficacy. If only 6 patients enrolled (not completed) that could be only 3 patients. Why not wait till all 7/8 completed trial to expand?
Even if they have to wait 6 months to get the 2 trials wrapped up, 6 months is a short timeline in biopharma...
I can only imagine those feathers are going to get a little more ruffled as the share price continues to increase...
I know A 2-73 seems to be almost boundless from an indication perspective. Do you recall if they have floated bi-polar disorder as a possible future trial?
So just an observation... this is a US based position. Only US based trial is Rett. Rett patients are on "speed dial" and known. Does this suggest ALZ expansion into US?
Nicely done. Makes pro comments seems rather... elementary...
What else did the Sales dept leak?
Trust me
Embarrassingly inconsistent with market sentiment.
Nice to see that some real DD was done and proved this post falls under the category of FAKE NEWS.
I got the same message sent to me from Scottsmith.
Maybe the same person?
The complete inconsistency renders such opinions into the realm of comedy.
"so I covered"
Seems like early morning sentiment changed by afternoon...? that type of swinging mindset should give all pause for any seriousness in posts
I think it's real hard to draw any conclusions considering the source has been so consistently wrong...
Here I will fix this for you:
"Stock holding up well today. The large seller is finished."
Probably should have just left the original correct version before it was made incorrect.