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Yup the big boys hate this kind of company because they don’t get the inside track when it’s still a unicorn and they can pour billions of cheap Bankster me Fiat into it giving the public the risk and they take all the rewards. Dr. snuffle up a guess the brainchild find hiring our CEO and doing and run around the investment bank crooks and their bastard unicorns is pursuing a vision and executing quite well. Having a CEO who knows the game in those how to fight off the banks are crooks as well as how to advance the science both in the lab in the clinic and in the board sorry but I’m blind take typing is difficult so please excuse series problem with my Baltimore accent.room is our secret sauce I think he is holding back and setting the battlegrounds so that that the Goliaths go to world with each other just for the chance to hold her hold our hands for a dancer to
The 502B pathway is straightforward. It is possible at the company is in talks with the FDA about evidence in the data needed for approval at this time with no more studies. With approval and superior efficacy the company may be able to go directly to market finding only a partner for sales and distribution. A similar path way may be in the works for BROM. As well as the forSP. That’s three lotto tickets bought and paid for just waiting for the man to pull the ping-pong balls out of the box.
Sorry for errors with series listening skills.Pony poop is everywhere. The submission to the FDA on rats was accomplished as promised and the FTA must respond by the end of this month. No response is equal to a positive response. Given that and effects has been working with the FDA for a very long time optimist can anticipate that the rats submission is pretty much a done deal. It is only logical given the conservative nature of the FTA and the proven absolute necessity of conservative PR’s that any news on a Alzheimer’s trial in the US or North America would wait until the results of the RET trials are in. Including dementia in the European trial with Parkinson’s just had’s strength to that path way. I have decided that my boat is fully loaded and that I want to keep a lot of powder dry just in case market goes completely in the crapper.
Add it. Management confirmed that they submitted to the FDA has previously promised, on time as promised. FDA must report back in less than two weeks. Also mixing Parkinson’s and dementia in one trial is absolutely freaking brilliant. This way they get the easy to mention excuse me to measure Parkinson’s tremor results plus they get dementia thrown in for free in one nice tidy package. I only added a tiny bit because the boat is fully loaded but I’m tempted to just throw caution to the wind.
Regarding the common assertion that in and of 27 is anecdotal… “ you can have an N of 1 million and the anecdotal, and have an N of one and be significant
nassim Telab
Has stated during the Fletcher 2015 conference question-and-answer period.. he was a former Options trailer for 20 years to retire to become a philosopher professor and author of most famously the book the black swan.… In my opinion and a vex a the XL will prove to be a black swan to the shorts and the big Pharma and to all those who used to be long and have bailed. My apologies for typos as I am blind and difficult to edit
Please excuse the errors of Siri. It’s difficult type when you’re blind.You might be right perhaps that something that changed last year was the election of Donald Trump and the appointment of Dr. Gottlieb. Given the nature of bureaucrats especially FDA bureaucrats one could expect from Mendez resistance to a major change in the scientist methods used to discern safety and efficacy. Add to that the tremendous political resistance to the president any of his employee in appointees in any of the resulting possible successes that could be attributed to them, there must be tremendous in fighting inside the FDA and dragging her feet perhaps down to the level of the secretaries and the mailman. It is unlikely that a good doctor could have perceived the potential depth of depravity of the resistance movement inside the FDA. I don’t think this can last foreverHas sooner or later they will either give up or somehow the scandal will be exposed. On the other hand it may be that there is no malevolence just a severe effort to be absolutely focused on getting it right. I have continued to add her in the last few weeks and sold a little bit a bitcoin today for some more topping off.
That would be fantastic. We were patient and committed to our understanding of the science and their understanding of the finances and the management of the company will then have an even better opportunity to rebalance more into the speculation.
Apologies for errors in series listening skills especially the name of the company but I am blind wanted to get this out don’t have access to keyboard right nowAccording to the company the delay was because of the need for additional gnomic sequencing and other precision medicine data if my memory serves me correctly. This may have been part of the back and forth with the FDA in order to nail down A clear path to an and D a. However it is possible there was a more sinister reason and that is that the resistance of the R slow down The approval of the protocols in general for this kind of study. Now that the protocols have been released and the resistance is crumbling on all fronts not just within the FDA, then the last few details have to be ironed out for the trials to begin. For obvious reasons it would have been colossally stupid for the company to place any blame on the FDA for the delays but I think that the resistance has been trounced in the FTA should become a much more a fission rapid any Factive partner in accelerating the drug discovery process not just for anaphylaxis but for all the companies the follow using the new streamlined and much more intelligent protocols.
Please excuse some mysterious Siri errors as I am speaking this due to difficulty typing wineOver and over and over and over again early understand or‘s make fortunes on innovations. Andrew Carnegie was the first to hire chemists to systematize the blast furnace. John D Rockefeller was the first to standardize petroleum byproducts. Steve Jobs was the first to mass-market a visual interface first on the computer and then on the telephone. And plenty of fortunes have been made by people who have understood breakthroughs in medicine and pharmaceuticals before the crowd. I told by Dr. about out of X and he was quite adamant that I was nuts that all CNS diseases are unique and that he had seen that in the clinic. I have a friend who I got into a VXL and he jumped out after a small loss at the begging of his broker in Baltimore The fact is is that one has to dig a bit to find this diamond also it is the nature of today’s market that almost everybody is into index funds that have been floated by the gusher of cash from the Eccles building. There are very few stock pickers in the market and even fewer risk takers and even fewer risk takers with patients. Then of course there is the rampant and widespread idiocy that coaxing out a signal from a 3000 person study is more valuable than having a signal fall into your lap with a 25 person study. Not to mention multiple over lapping statistically significant signals using different biomarkers. So in my mind this is not and if but when stock. And the plan is largely up to the FDA’s ability to move fast once the data or in on Bretz.
The FDA has F space deed me twice in my life once taking the love of my life and one steak in my eyes they will not do it a third time. They will take my shares out of my cold dead hands. The resistance is strong and the old-school believers will also resist any change to their last breath. But change will come I want to give a shout out to the shorts and the resistance for giving us this opportunity to make our large positions even more gigantic. It may not come this month and it may not come this year but we will see what winning looks like.
Post that this replies to give evidence of old-school FDA resistance
One could reason that because the resistance is at the ramparts threw out the federal government that there are large elements within the FDA give a higher priority to embarrassing the presidents appointment then the priority to give to saving lives. Thus we might have to wait until the new year and perhaps well into it before Gottlieb overcomes deep entrenched political resistance to reform. This would be a fantastic buying opportunity
Baby biotech speculative and appeals to people with a speculative sensibility. Those same people tend to be forward looking and see the extremely dangerous situation in the general market. That is why I think we suffer here and will always be under valued relative to our actual value but it doesn’t matter because our actual value is about to increase exponentially
Bit coin shot from 30 to 1000 in a matter of months and took three years of consolidation before it broke out of the 200 to 700 range. It is just the way the market works. Early retail with large positions that are not absolutely rock solid hands must be cleansed by boredom or despair before the next big solid move can be made. By now , we have a much broader and stronger cadre of shareholders.Selling is exhausted, and the short wolves know that there are not many weak hands left to keep a short party going. JMHO. Setting the stage before the big science show. Remember the song... She dazzled me with Science, She dazzled me with Science, Science Science.
One would suspect that Biogen would be sweating bullets to get a deal done before the MS papers come out IMHO Please excuse if this thought was already discussed.
While I do not agree with the prescribed action, it was still funny
The bureaucrat mind avoids visible failure regardless of massive unseen costs. that is why I am blind. The FDA waited five long years to approve HIV drugs in the protease and NNRTI classes. Can't have anyone die from our approved drugs even if hundreds of thousands die in the meantime.
I am confident that the incumbent FDA staffers are committed to the old mindset. They have endlessly repeated the "heroic" role the FDA played in delaying Thalodimide.
They will not give up on that mindset easily. Therefore, I could hypothesize that there may be some folks in the FDA who would relish a catastrophic failure on the first drug approved with the new protocol. Another incentive for the entrenched to root for failure. Is that Trump appointees, and Congressional Rs support the new protocol. Most in DC would throw their mothers into the rotors of Helicopter ONe if they could hurt the Orange in Chief.
3.75 Billion plus 37.5 percent royalty???
There are 3 billion base pairs in each human cell. There are twenty six participants. Therefore there are 3billion to the 26th power possible different combos to sort through. If you only look at one billionth of that, there are 3 to the twenty sixth power different combos to look at. Yes , this is oceans of data. It is a combination of a scientific and a business decision how deep AVXL wants Arienna to dive into that ocean and come up with a tasty fish. Thus , IMHO, that data will be available when Herr Hair says it is ready. He certainly has both the science and business cred to make the call.
There are and was oceans of data to sift through to search for the last correlation. That is why the final data can be declared at the time and place of managements choosing
Here is my SWAG about what is goin on.
The good Dr. Has a verbal with Biogen, and has gotten a nice chunk. But Biogen scientists are a different lot than investors and biz folks, who would recoil at the price exacted from a phase II company. thus , we have to wait for Phase III to commence. Meanwhile, Biogen demands silence, so far as is legal, to prevent hostile overtures from materializing.
Just my SWAG from what seems to be goin on.
We wait for the FDA...
there ,fixed it for you.
Perhaps all is on the launchpad, just waiting for the new rules to kick in?
Does anybody remember what the final grade was in the multi ton bulk sample they dug out a few years ago. If my memory serves me correctly, that turned out to be more than the grades all the valuations are based on now.
It is hard to see NYC from SF, but maybe, just maybe, the results were solid at the end of 52 weeks, shown to potential partners, and awaiting decisions to grind out of the Big Pharma C suites.
Uncontrolled info might lead to an uncontrollable hostile takeover at a price well below most of our targets.
Herr Doctor knows the ins and outs of the game.
Is there reason for confidence in the science. How many different diseases has 273 been tested on, in how many different models, in Vito and vitro.Of all these tests, has there been one failuree? How many were performed by academic third parties independent of AVXL. How many other papers have been written about Sigma 1? while the MO is not fully understood, that is a given in nearly all drugs, as evolution has produced rather obtuse and opaque mechanisms. the basics have been systematically developed by the inventor of 273 over many years of study and experimentation, and fiddling.
And if X has stated that they will be working at each individuals genotype in order to find any precision indicators on a personal level. There really is no end to help many calculations and comparisons can be made. Therefore the decision of when the data is all available is a rather arbitrary time when they say OK we don't want to crunch any more numbers anymore. In all likelihood one could help at that decision would be made mostly for scientific reasons and to the extent possible for long term market value. Please excuse any errors made by Siri as I am blind and it's difficult to edit.
The term homeostasis has been in use for a very long time. In particular, I remember my animal Behavior courses from back in the early seventies where much of the behavior was linked to keeping systems balanced, like pigs sheltering from the southern sun, and turtles sunning on a rock are examples of behavior meant to keep thermal forces in homeostasis.
When you are holding a royal Straight flush, one just might want to be a little coy, till all the bets are in.
Patience Grasshoppers.He says this year. I believe him. When the PRs come out fast and furious, they will include a nice. Flurry of money , plus a clear path to approval assuming certain end points, pretty much pre approved.
For those massively long, a major drop would be a welcome opportunity to really load the boat.
Didn't Adam F. Pull some doctor out of his uuuuummmm, uuummm, hat...to opine on his learned opinion that Anavex was fake science?
Adam will probably be back sometime, but it will take a parabolic move to Jupiter that needs to crash to the Moon, but by then the market cap might so big that all of Adam's horses and men couldn't push us from the top of the hill.
I am in the Industrial Hygiene biz. Back in the day, I developed A database on the mac for asbestos inspections. I sent my techs out to the field to use it on a floor tile survey in an old store on Drumm Street. I made them map out every layer, just becuause we could, imagining that the abatement contractor would care. It drove my techs crazy, and later they told me that they were considering methods to dispose of me.
the point is, that nerdy types ,like myself, can sometimes get lost in the weeds, especially if one is in love with the hottest new weed detector, measurement and classification machine.
Perhaps the FDA nerds which to leave no nucleotide unturned in search for some clue as to MOA and the genetics of ALZ. Sifting through the billions of base pairs in the trials participants DNA, to look for some connection to outcome on the parameters of ALZ has to take up more computer power than calculating the meaning of life and everything.
IMHO, the good Dr. Is more practical, but he is in no position not to say how high? When the FDA sez jump.
So we wait.
But he has promised this year, and he knows the cost of even having the glimmer of overpromising, so we calmly wait., Like John Glenn on the launchpad, while every system is checked and rechecked.
while we are waiting, just think about how happy those RETS parents are going. To be when their little girl hugs them, and says , I love you mommy.
Perhaps the delays are due to the FDA being very ,very careful before approving a protocol that would nearly lock in an approval , if certain data points are proved. AVXL management might also be extremely cautious in Roger to prevent failure.. At some point both parties both have to decide enough is enough. It is clear from recent announcements that the time is nigh, i.e. Before Fall.
We could end up having a strong move window news just as bitcoin has simply because there's of larger pool of people out there that know about us and that Paul was probably been building over the last few years and therefore once we start momentum for any reason we might keep going even before any big news. Sorry for the Siri dictation errors but I am traveling with no keyboard.
Silence is golden. .. E.O.M.
I share your concernseom
First of all would it not be foolish to lie to the patent Office.
Second, does it not take a long time for a published paper to wind its way through the peer review process.
Third, if Anna vex paid for these studies, would it not be it's prerogative to decide the best time to publish. Publishing The results of a handful of tests outside of a placebo controlled trial would be waving a red flag in the front of Adam F and his ilk.
There are two usual reasons that drive regulators to join Pharma after retirement.
The first reason is that they want to cash in with big Pharma , and use their contacts to get good or not so good drugs pushed through.
The second scenario is that they are thoroughly decent human beings, who want to help make sure that a promising drug gets through the pipeline. Contacts with other respectable within the FDA might also help.
Either for greed, for compassion, or both, it's all good.
The author of the Black Swan Nassim Taleb, has as one of his themes , that progress is largely incremental due to The accumulation of empirical evidence. He sites many cases where the theory follows the incremental empiricism.
One example is he gives ,if my memory is correct, is the development of the jet engine.
i have an insight to that particular observation. I My father in law had a very nice brass Christmas ornament. The device was powered by a candle that turned a small brass fan above it, that drove a device that rang a pleasant sounding bell.
The point is, empiricism is greatly underestimated in the study of scientific progress.
Some people just have to have a theory behind the observations, not that there is any thing wrong with that.
Now, if you look at the history of Anavex 273, it's discovery was largely experimental. Observations were previously made in the literature that the sigma one and muscaremic receptors were important. The receptor was extensively studied and somewhat elucidated. then some chemicals were chosen to fit to activate it. The structure of the chemicals were tinkered with, until 273 was found to work pretty ,pretty good on both. then 271 was found to be even better.
I do not know if any of this research progressed with a theoretical model for all the intricacies of regulation that the receptors are part of.
Walk softly and carry a big stick. EOM
Is Anavex part of any indexes? If so , many of the shares may be owned by the passive Index funds, not that there is anything wrong with that!
Passive funds are a major problem for corporate. Governance as they mess up the 50 percent rule when it comes to shareholder voting. Passive investing. Has taken over a large part of the market.
Of course, this might work in our favor in the event of a hostile attempt.
He has to be extremely careful, as Fierstein, Rosen , and the gang will pounce at any spilt kernel.
Does Park
West have a history of aiding and abetting hostile takeovers on the down low.?
IMHO , this takeover business is a just plain fraud, existing because the M and A banksters and large corps rule.
If ownership of one share is said to be the ownership. Of a piece of the company, and the big money. Can steal up the upside, then one really does not own a piece of the long term prospects.
I have it done to me many times in the gold junior space. Where I buy a really terrific prospect at x dollars, and a bear market takes it down to one tenth x, and then a hostile takeover swoops in and buys. It for two tenths x.
The longer Hair Doctor sic. Can hold up the data, the more he can release to get a bidding war going..
Of course, there are lots of other ways to punch the takeover in the face.
I think they could make a partnership deal that would give the partner everything in the event of a hostile takeover.
Like somebody just said, there are smart lawyers on both sides. But somehow I have the inkling. That the Hare Doctor has an edge on that playing field too.
Everybody has a plan until they get punched in the face.
George Forman?cc