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So says you, Mr 88%.... §
When Missling delivers the results next Tuesday from 9:40 to 10:10AM ET AVXL will experience a U3 halt for the rest of the day and open Wednesday at $12.20
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Oh, you so get it. I will be glad to sticky that! §
Reading is fundamental. The mind is a terrible thing to waste...time underestimating.
http://thescienceexplorer.com/brain-and-body/placebo-effect-stronger-and-more-bizarre-ever
MOM only works in 12% of the population. The rest need the drugs.
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I'll give you peeps a great OTC pharma pick if you promise not to go spam the board up like you did this one.
This company has a bunch of otc health products. They have shelf space in Walmart, pages on Amazon...the works. They have a website, but even better all their products have their own websites, much due to developed acquisitions. International presence. I am very impressed.
I scalped this one I speak of real good, too, last month. Upon doing some post-laughs DD I found a very interesting situation. I'm all reloaded and a nice fluffy PR yesterday is creating some good volume today. You'll have to check it out.
Just as a little goodwill gesture for all you newbies. Maybe help give you a better idea of the kinds of posters to listen to on iHub. If you are a freeber and think you know what symbol I'm talking about, reply(without revealing it!) and I'll PM an email addy you can send your guess to. First right reply wins a gift month! Let me know what you'se thinks!
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Yes, Tocris, BioTecne, R&D...all the same. They have the GMP license. They supply the others, and it is unavailable across the board.
Aw that was sweet Still can't find the A2-73 research compound available. I called Tocris(BioTeche) and asked the very German woman, who replied only that it wasn't available and no date for availability and would I like to be contacted if/when it was.
Perhaps they make the comound unavailable after a certain stage of development. Perhaps based on IP status. From my level of experience I do not know...but likely it's just that and no indication of anything. Doesn't hurt to poke around. For instance...
The adis-insight page has changed; my scribble notes from 01/12/16 say:
Phase II - Alzheimer's disease
Preclinical - EP; ALS; Stroke
And now:
http://adis.springer.com/drugs/800033840
"25 Feb 2016
Preclinical trials in Rett syndrome in USA (unspecified route), before February 2016"
I consulted this table to try and figure how long this might take, but could not match the type of symptomatic testing they likely are doing with the Pre/Nonclinical Study types. Consensus is human toxicology from the AD P1/P2a is sufficient to gear the preclinical study towards a P2 efficacy trialBut I figure it can't be more than 3 months, considering the aging timeline for the rodents. 6 months max for included analysis would be August but I think a June-ish date more likely. Will note to check the conference calendar for dates.
Real life heroes are inspiring. Like our Doc PJ:
http://www.highcountryhealth.com/category/doctor-reports/doc-pj/
Only Love can fill the cup of life
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It's also rising off the lows right along with the indexes. <4.00 was a no-brainier. I had 3.88 bids in but they no-touchie. Your play-by-play has been lock step...good calls. Yes, I wonder where those peeps are that were going to load up. I hope they followed their own shpiel!
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I feel for you peeps who have stuck it out. You don't deserve what tomorrow will bring.
Best wishes
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Because imaging is not yet a validated biomarker. Though the strength of the anecdotal evidence from them in the brain-wasting diseases is always increasing, helping to amass the data necessary for their validation, as your link points out.
http://alzres.biomedcentral.com/articles/10.1186/alzrt276
TauRx and vTv are both using imaging as SOMs in their studies:
https://clinicaltrials.gov/ct2/show/NCT00515333?term=TauRx+Therapeutics+Ltd&rank=1
https://clinicaltrials.gov/ct2/show/NCT02080364?term=vtv&rank=2
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I bet you're still laughing...I am!
This is textbook shenanigans here!
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The final hour was absolute carnage. Biotech down 6% today. 5 weeks of gains wiped out in 2. IT MUST BE MAY!
AVXL holding it's own, thankfully. Your T/A is optimal during these silent periods and surely indispensable to optimistic investors looking to accumulate. Other charts posted have not borne the results that are claimed as indicated.
If the sector bottoms and turns up decently next week the pundits will be praising Missling for his timing, you watch!
I'm not laughing...sweating maybe. Thanks for posting.
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Are we calling this study the P2b? "I shall refer to it herein as so!"
The P2a record shows:
Estimated Enrollment: 32
Study Start Date: December 2014
Estimated Study Completion Date: October 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
The data collection is 12, 36 & 52 weeks for CBB and EEG/ERP with no 26 week test. I would conservatively think we would see updates for the 12, 32 and 52 week points and not 12, 26 & 52. Perhaps the 12 week at CCS, no update at AAIC, the 32 week after October, and the final outcome March, 2017.
The time frame for the P2b is - Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 so by March, 2017 the cohort should be finished with the first 13 weeks.
Can't imagine if/how they will disseminate interim updates for the extension while the P2a is still ongoing. It will be nice to see, perhaps, a study entry for the P2a in 2017 that says "Completed, with results".
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Exactly, hence the chart.
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Yes, totally...I believe.
YUCK! That sucked. Took a loss...oh well, can't win 'em all!
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That's right. More specifically, the MM(computer algo) takes the measure of volatility and moves the price based on momentum to the orders that can best maximize that volatility. They don't care about price, only trade volume. And that is the mechanism which provides an "orderly" marketplace. Without them it would be a constant Mexican standoff.
As a passive investor, you don't care...you don't deal with the mechanisms. As an active investor/trader the MMs are your soldiers, and you must learn to command them.
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I think we will get the delayed 12 week update next week and the 26 week at AAIC. The presentation bullet "Present at 3 scientific conferences" is vague. 3 total this year? 3 more as of the presentation(what I assume)?
Perhaps they are PRing the Q numbers ahead of filing the report on Friday, and they will PR P2aA PK data along with that for road show effect ahead of the conference.
We needed the financial update before presenting scientific data. Missling does do things in a responsible, systematic way. I trust him on our side of the chess board.
Macfarlane is just trying to help secure continued development funding. He knows the score. The truth is AD treatments have historically been shunned by the age-based demographic of industry and government. They didn't have to worry about old timers disease...but colon cancer, THEY WERE FULL OF IT! Now they're getting old and forgetting, for some strange reason, what they wrote in that cancer funding brief.
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The SOS docs show:
Common Shares $.001 Par Share Count - 400,000,000 Authorized Shares
Preferred Shares $.001 Par Share Count - 50,000,000 Authorized Shares
Perhaps some fluff will hit and it will pop for you. Best of luck.
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Take it and run! Remember, that's from 2010. Here is another..sort of flip side of the coin.
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Failure of Dimebon Raises Questions about Alzheimer’s Trials
by Jim Schnabel
March 11, 2010
A potential Alzheimer’s drug that had seemed to perform spectacularly well in a medium-scale clinical trial has now been shown in a larger and more conclusive trial to have no apparent effect on the disease.
The surprising failure of the drug, known as dimebon, is yet another disappointment for Alzheimer’s researchers as well as patients and their families. It also raises questions about the conduct and design of Alzheimer’s clinical trials, particularly in Russia where the initial dimebon trial took place.
“The prior doubts about the Russian trial appear to have been borne out,” says Sam Gandy, an Alzheimer’s researcher at Mount Sinai School of Medicine.
Dimebon (generic name latrepirdine) was originally developed and briefly used as an antihistamine in Russia in the 1980s. It began to be re-evaluated as a potential Alzheimer’s drug in the 1990s, after Russian researchers reported that it seemed to boost the levels of memory-related neurotransmitters in lab tests on brain cells.
A San Diego-based company, Medivation, Inc., eventually began clinical trials of dimebon in Russia, where the drug was already approved for use. In 2008, astounding results were reported in 183 Russian patients whose Alzheimer’s dementia was classified as “mild-to-moderate.” Half had received dimebon at a dose of 20 mg thrice daily, and half had received a thrice-daily placebo. After six months, the dimebon group scored much higher on standard tests of cognition and quality of life, and follow-up studies suggested that the progression of the disease had been stopped. The apparent “treatment effect” was the largest ever reported for an Alzheimer’s drug trial.
Some researchers expressed concern that such a powerful result was too good to be true, particularly since no one really knew how dimebon worked against Alzheimer’s. However, several well-known U.S. clinical trial experts had observed the Russian study and vouched for its validity. Other researchers soon reported evidence from laboratory studies that dimebon might be able to boost the general survival ability of neurons in a way that could make them resistant to other neurodegenerative diseases too (see “Hope and Caution on Russian Antihistamine Drug for Alzheimer’s”).
Unfortunately, dimebon seemed only weakly effective in a small-scale clinical trial in people with Huntington’s disease; its results were reported in February. And on March 3, dimebon’s candidacy as an Alzheimer’s drug was most likely terminated.
On that day, Medivation reported results from a large, apparently definitive trial of dimebon in 598 people with Alzheimer’s in North America, South America, and Europe. Those results suggest that dimebon, while safe, is completely ineffective against Alzheimer’s disease. The data failed to show even a hint of a consistent impact on patients’ cognition and quality of life, compared to a placebo.
In recent years, a number of Western drug companies have used Russian hospitals as a relatively inexpensive proving ground for early-stage drug development. However, in at least one other case, a positive result from a Russian trial has failed to translate to a larger, more rigorous Western trial.
Gandy says he wonders whether “something is systematically wrong over there.”
In the case of dimebon, not only the early clinical trial results but also a significant amount of laboratory work appears to be of questionable value. Over the past few years, researchers who were eager to find dimebon’s mechanism of action against dementia have reported, for example, that it blocks the toxicity of amyloid beta aggregates found in Alzheimers, or that it enhances the survival of mitochondria. If nothing else, the case underscores the weakness of such laboratory evidence in the absence of data in people that confirms it.
“At the moment I don’t think that any of these effects is clinically important,” said Gandy, whose own research group recently found that dimebon actually increases amyloid beta levels outside cells, in lab dish and animal experiments.
To some researchers, the dimebon failure, and the failure of many other Alzheimer’s drug candidates to date, points to a larger problem: The treatments are started too late in the course of the disease.
“What you want in such trials are people who are just starting to lose neurons, but typically by the time an Alzheimer’s patient goes to see a neurologist, his or her brain has already been severely damaged,” says Jeffery Kelly, an investigator at the Scripps Research Institute in La Jolla, California, whose work has focused on amyloid-associated conditions. “Considering the way the Alzheimer’s trials are being done now, I’m not sure that even a great drug could be discerned as such.”
Gandy agrees: “I think that our best chance for impact on this disease is presymptomatic intervention and prevention.”
http://www.dana.org/News/Details.aspx?id=43057
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This is where the bears get their ammo. Also where the company and compounds take a different approach.
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There's a WOW! Delivering the Q two days early. I had expected -.10 to -.12 Missling is impressive!
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Great insights XenaLives! Here, you'll love this one. An article from former Anavex CEO/Chairman and present Kalobios CEO Cameron Durrant. Still trying to figure out why he is listed as inventor on the new WO/2016/064711 application.
http://www.biospace.com/News/an-overview-of-the-alzheimer-drug-market-written/177902
"In Phase I or the other side of Phase I, Anavex is going to have a bunch of other companies wanting to partner.
Be prepared for an exciting ride." -C. Durrant
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Ha Ha Ha! I have known a few Greeks who were real characters, so I have this image of Dr V in the lab...just as you described. Much like my image of Dr Patrick Soon-Shiong:
I came across this interesting site:
https://www.lawinsider.com/company/1314052/thrifty-printing
Lots of boring boilerplate, but with a copy of the original 2007 IP agreement:
https://www.lawinsider.com/contracts/6ykTcJ5zGohRTI8bA8gA3u/thrifty-printing/exec1389011/2007-02-07
"Forward with the putative prototypical optimizations!"
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THERE-THERE french roll! §
Not to mention "Put the Screws to JS & LPC Award - 2014 Toxic Financier Taming Assc"
We got suits.
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Yeah, I'm good for 22KK 1.22s...should be fun.
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If he creates shareholder value, the stock price will take care of itself. My comment was in reference to posts that sound like it's his responsibility to dance like a bullfighter and respond somehow to every outside catalyst.
Another point to look at next year. Last year he did pretty swell.
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K&L Gates is the corporate attorney. The AM was held at their NYC office. Yes, that was Parker.
Signal for what? Extensive international expertise? Yes. We know that...it's in the DD.
McMagyar: A good trader has a long, short and cash position. Easier to play the game.
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Gonna start moving! §
The stock is the least of Misslings concerns. But, yes, as peeps point out, tutes will get their shares in the end. All those companies with 50%+ tute ownership did not start that way!
Missling is a manager, not a promoter. It would be nice if posters (not directed at you) would stop expecting him to act as such, and give him a little credit.
Your thinking is correct...good management. We are indexed in the IVV now!
Where's all the clowns? I know you're reading 'cause they have stats. Soaking up all that juicy, FREE DD down in their holes, I suppose.
BTA
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Muy Bueno!
22,000 @ 4.22 X 4.46
Blahblahblah. Own what you know!
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Is that illegal?
Another curiosity. The 14/395581 Dr V app is written in a particular verbal style of, presumably, him and/or his PA. The other Anavex patents all have a common style unlike Dr V's "valorizationalisms". The response to election looks very much like the wording was extensively changed from that Dr V style to more like the other apps. Better grammar.
That was filed on 04/14. Then forwarded to examiner on 04/21, the same day the right of assignment was filed. Then the entity status change on 04/25.
That looks, to me, like Anavex took(forced?) assignment and assumed prosecution. Now it looks like two PLUS apps in play and from comparing the two, I'd say the Dr V app stands a better chance of granting and would not be surprised to see the other app abandoned...typo and all.
Or is my coffee and maple syrup too strong?
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Then is the fendinline(unassigned) owned by Anavex?
"six U.S. patent applications with various international counterpart applications."
What's missing from this list of 5?
U.S. Pat. App. No.13/940352
WIPO Pat App No.WO2016064711
U.S. Prov. Pat. App. No.62/065833
U.S. Pat. App. No. 13/777471 (12/522761)
U.S. Pat. App. No. 14/395581
U.S. Pat. App. No. 14/865862
(U.S. Pat. App. No. 14/406271 - Dr V's Fendiline app)
"The most recent U.S. patent application was filed in July of 2015."
Would that be 14/865862 - Filing or 371 (c) Date: 09-25-2015? Also unassigned presently. I didn't find one with a closer date.
Certainly starting to definitively look like "all patents are unequivocally owned by Anavex". You're speculation 2) is interesting, especially if we see DR V's other apps assigned in the near future. Ink time!
Very nice, indeed.
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ps- I had also wondered about the examiner pointing out the mislabeled 2-72 on the PLUS app. It was not corrected on the reply, IIRC, and I thought that odd.
Balk! I checked patents today, but not the assignment tab! Glad you're around bud! I did want to comment on the Micro Entity Status and how he could have been filing under that:
"To qualify as a micro entity, an applicant must meet all of the following criteria:
Qualify as a USPTO-defined small entity.
Not be named on more than four previously filed applications.*
Not have a gross income more than three times the median household income in the previous year from when the fee(s) is paid. For 2011, the most recent year that data is available, the median income was $50,054.
Not be under an obligation to assign, grant, or convey a license or other ownership to another entity that does not meet the same income requirements as the inventor."
http://www.uspto.gov/custom-page/inventors-eye-advice
This is one of the things that leads me to believe..."Dr. Vamvakides is no longer in a position to continue perusing this application..."
I tried to compare the election responses between this and the PLUS app to detect if this has a better chance of passing...yeah right! "My give up."
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Rats jumping ship. Merger last year failed (ViaDerma II) and co is bleeding red.
"On March 16, 2016, a portion of accrued interest of the convertible promissory note in amount of $2,000 was converted into 4,000,000 shares of common stock of the Company at the conversion price of $0.0005 per share.
The remaining balance of promissory notes was due as of March 31, 2016 and the Company has been in negotiations with the Holders of the promissory notes, but has not yet reached an agreement as to repayment schedule. The Company recorded the default interest and penalty of the notes in amount of $97,249 during the year ended December 31, 2015, and the accrued interest payable of $273,272 as of December 31, 2015."
A/S has been increased from 150MM to 400MM to make room for massive toxic floor-less convertibles.
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Like a hawk circling above a brood of squawking chickens...Love it!
scottsmith: HERE-HERE! ...and then again...NOW-NOW!
Ordering a $12,000 cup of coffee for the open tomorrow.
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