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Interesting info from Biogen's CC
Have stopped testing of Bib-61 their product that promotes re-myelination, but didn't mention testing of Anavex 2-73 MLA directly.
CEO working on new innovations and " in discussions"
Looking towards early clinical developments for asymmetrical value and are open to something later in development. See value in ODD(orphan drug development)and the intersection of neurological disorders.
GLTA
Thank you for posting. Article lends credence to our hypothesis for 2 73.
"Bio bear market is over" yes I totally agree with you. Started 17 months ago with a major pullback, and the average bear market lasts 18 months, so we are at a very good position to own shares.
Hi F1ash here is a link to preclinical testing in the mouse model.
http://www.nature.com/npp/journal/v38/n9/full/npp201370a.html
I believe the first testing of S1r was in vitro, in a dish. Neurons were dosed with 2-73, and tested with chemicals that cause damage, at this level 2-73 showed neural protective qualities. Then after not failing they moved onto murine models. After publishing their work on mice; moved onto an a phase 1 trial, developing a range for maximum tolerated doses in health volunteers. The phase 1 trial also established PK/PD data. All the way along the company has tried to fail the compound as quickly as possible, but so far so good.
Altogether, no other receptor has ever been associated with so many different diseases as the Sig-1R. It has so far been implicated in illnesses like Alzheimer's disease, Parkinson's disease, cancer, cardiomyopathy, retinal dysfunction, perinatal and traumatic brain injury, frontal motor neuron degeneration, amyotrophic lateral sclerosis, HIV-related dementia, major depression, and psychostimulant addiction (Su, 2015). How those two modes of actions of the Sig-1R may relate to this plethora of diseases remain to be clarified but its protective influence has been verified on various aspects of cellular processes, such as calcium signaling, mitochondrial functions, ER stress, survival and apoptotic pathways (to be discussed later), and tumor cell proliferation (Tsai et al., 2014). "
Keep the Faith, have a great weekend
"Homeostasis" really means "normalization."
Normalized cells don't divide or metastasize.
True, but one hypothesis is that cancer takes control of the S1R, thus protecting the cells from apoptosis in hypoxia and limited blood flow.
Anavex's 2-73 is an Agonist, and cancer would be one also; which one would have the greater affinity to achieve the desired result is the question.
Anavex's Anti-agonist, therefore might work better to turn off the S1R,thus cutting off cancers protection.
Please feel free to expand on my simple understanding:)
Neui Thank you for posting the link to the 21st Century cures Act lecture. Very interesting and positive for our approval.
Oops I think I am a decimal off, how about $3125/yr 260/mo.
Whiskey I was going through some of Dr M's interviews today, and he referred to a UBS estimate of the potential market for AD as being 13 to 67 billion per year.
If we use 50b per yr as a round number and the worldwide patient count of approximately 16m, you get 31,250 annual run rate or about $2,604 per month. Please someone check my math:)
-----------------------------------------------------------------------------------Tomato Potato, I have no idea how much the treatment will cost (none of us do) but HIV medicine currently runs about $4000/month ($48k/year) and when some meds first came out, cost $10,000+/month ($120k+)/year.
For all we know it costs $0.01cent to produce a single pill of A2-73, so it could be as cheap as a $1 a day, or Dr. M is going to factor in the cost of development (past present and future) in to the price of the one treatment they have approved and charge according to a business model.
But no one knows, so this may not even be a Tomato or a potato, it could be an orange or an apple, regardless, what we do know is that this conversation is a conjecture that no one has the answer to except Dr. M.
-------------------------------------------------------------------
True I found MSFT in 1987 bought 100 shares @ 69 rode it up to 800k, everytime I sold and bought something else, it didn't work as well. I remember my professor saying they had a monopoly, 10 million computers running their OS. Thank God I bought some.
I think Avxl is going to have a similar trajectory. Very large market in multiple indications, monopoly position in many CNS diseases. I would think there would be at at least 180 diseases along with variations of those that have potential for treatment with 2-73.
I make this statement based on the recent finding of 180 areas of the brain that have been identified.
Un-diversification is my strategy too. GLTA
Looks like Rett organization is under the funding heading. Biogen looks more like a partner at this point:)
Is anyone familiar with Duexis, a drug that was granted patient protection for the combination of Ibuprofen and famotine to help insure that people taking large quantities of Ibuprofen don't burn a hole in their GI track.
These were two approved drugs that bring nothing to the table as far as new art, yet it was approved by the patient office. Just say'n.
Also the patient argument is moot. Let's say we don't have patient protection, we have how many years lead on research already reviewed. How would a company come along and replicate data without clinical trials, and get approval. That would take a long time and during that time the first to market would have a substantial lead in revenues and continued evaluation of newer improved products.
Great article. Thanks for posting.
A discussion broke out the other day about why big pharma has continued to go down the wrong path and why I think Anavex is continuing to advance towards approval.
My thought was that BP has put so much money, time, effort into their research, that they are having a hard time pivoting from
their group think of the original hypothesis. They continue to try to parse data to find the subgroup that shows results. If I were a shareholder of those companies I would consider a class action lawsuit for malfeasance of fiscal responsibility. Multiple failed trails is no
way to manage shareholders money. Where are the multiple firms jumping on these guys the way they piled on us last year?
I submit that Anavex is checking all the boxes, submitting data to scientific review, showing results that are beyond expections confirmed by third party research organizations. Developing a team of advisers with distinguished backgrounds in relevant fields.
Some insight into our stealthy company, Fidelity has a risk/reward assessment for Avxl and it is point one, not even above 1.
When asked why this is so low, and how could they be so far from seeing the value, I have to say they just aren't doing their homework.
And to those people I say please,please,please short some more.
10% gain on a grant is way too much. Hmm let's make some assumptions shall we. If our product is able to become the standard of care for Alzheimer, say revenue stream of 5b/Yr and the normal market capitalization of a publicly traded company is 5 times revenue that would imply a 25b MC. Retts is a much smaller patient population, but continued validation by multiple organizations independent of each other, leads one to believe that evidence is mounting for much larger gains than 10%. Something will light the fuse of value, don't know what, or when but I have a stronger feeling that it will happen.
Yes TomP1 that's what I am saying, the founders of the company decided to buy a shell and move over their technology, so as to fly under the radar of competitors by not trying to fund the company with an IPO. I am assuming that going through a traditional IPO process would require a lot of discussion with venture capitalists, and brokerage houses/investment banks and financial insiders that would tip off Big pharma as to what the company was focusing on. Thereby reducing the competitive edge of what 8 years or more that they have on competition. Of course some companies, (and people) are still in denial on how effect the product is, but they maybe coming around. Pfizer cut their program last October, Lilly's CTAD data blew up...Axovant should just go away.
Like said, this is the best in class, Trillion dollar market cap, maybe.
I disagree, AVXL is different than other development stage Bio-techs.
They decided early on to not do an IPO, thereby reducing the information on what they were working on until a point was reached they were so far ahead of all others that catching up would not be feasible.
They decided to watch their costs by limiting labor, lab, research costs by outsourcing as much as possible, and therefore keeping costs to future customers lower and potential competition down because the price they could charge should be very competitive.
I think their model, as an organization design is the best in class, they have brought in a Board of directors, and Scientific Advisory Board that is nothing short of amazing. The best of the best.
One day the rest of the world will be touched by our company, yes every human being.
Cheers
I think the question is what company has the excess capacity to be able to handle the yuge demand that our product commands.
If we are able to fill the the trial, prove efficiency within 6 months, clear Australian approval process in short order,
Get manufacturers lined up and approved.
Distribution late 2017?
Time to book a trip to Australia. That would be a great Christmas present this year.
Good article thanks for posting. Adds to the puzzle of understanding why this is going to be yuge.
Awesome thank you for taking the time to summarize
Caveat Venditor seller beware in Latin
Why is Anavex so tight lipped?
I sight an example of what Biogen/Idec did to Bexxar(a cancer treatment for Non-hogkins Lymphoma);Coulter pharm was too open in their discussion of progress on the drugs' make-up, and Idec stepped in with another treatment that was able to gain approval before Bexxar. I think some of the early people involved are very aware of how important information is in our battle to get Anavex's product to market first. Hence the use of a shell company to conceal what they were working on as long as possible. If they had gone the IPO route, all of Big Pharma would have had a heads up many years prior. This has probably lead to Wall street playing games with the stock price, because they were not able to get their cut of an IPO.
JMHO
I don't think it is bad news, but the appearance of having to mine data, has some investors spooked.
I think a redesigned study with a washout period could help to stratify data.
It will be interesting to see how well the revenues are growing on the product released in June. I have been using the product for about a year and have had good results.
Fair enough. Have you ordered any of the currently available product? Or are you going to wait for the more potent?
It looks like the company has set up a strong management team; looks like it could do well.
Best of luck.
Article in Washington post about AF
http://jewishbusinessnews.com/2014/10/01/adam-feuerstein-accused-by-washington-post-of-propping-up-shorts/
Thanks George your input is always appreciated.
Any research regarding S1 in liver or pancreas cells?
Zika Virus possible treatment, CDC is looking for a drug that could treat some of the associated problems e.g. brain inflammation.
http://www.msn.com/en-us/health/medical/us-officials-the-more-we-learn-about-zika-scarier-it-is/ar-BBrDeay?ocid=spartanntp
Thanks Karin
I thought there was some kind of rule change regarding stop losses that went into affect end of Feb. To help protect retail. I will have to do some research.
Correct me if I am wrong, but wasn't there a change to stop loss rules end of Feb.
Thank you great post
It would appear that the S1 works to keep the cbd system from causing schizophrenic reactions. Yet another indication for potential use.
Hi Xena thanks for all your informative posts, appreciate your high level input on workings of the stock market.
Nice work. Put a little light on the SOB's. Some firm should file a class action against all the bogus firms for the losses incurred. Bet you would find some interesting ties.
CCI having bought MSFT in Jan of 87, I can say that the price you report is not split adjusted. I believe it IPO'd at 25, I bought in Jan 100 shares at 69, there were a lot of splits happening along the way. FYI they bought Seattle Computer's QD-dos for 50K (nice cost of goods)
Thank you George, more ammo showing postive effects.