Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Here is that Patent rule the author references:
--------------------------------------------------
35 U.S. Code § 262 - Joint owners
Current through Pub. L. 114-19. (See Public Laws for the current Congress.)
US Code
In the absence of any agreement to the contrary, each of the joint owners of a patent may make, use, offer to sell, or sell the patented invention within the United States, or import the patented invention into the United States, without the consent of and without accounting to the other owners.
----------------------------------------------------
I thought the email interview was kind of a mess, but I don't blame either party. I don't want to. Not sure if the author did a good job or not, but very happy that he is doing this difficult job. In the short run this might not be super clean, but this is needed to form a very strong lift off pad. Has to be hammered out to provide as much clarity as possible. That will open the flood gates for many investors.
I hope he waits till Monday to publish the article at this point, since it sounds like it is going to be very positive. And I hope he doesn't assume anything is obvious. It certainly is not obvious to me why Vamvakides did not sign that release. Just because it is not legally required? Or because there is bad blood? Or because he is trying to squeeze them? It would kind of be nice to hear from Vamvakides. Maybe he will agree that there is no issue. Doesn't sound like it though.
"Do you think the mentioned 52-week trial extension will be part of P2b?"
I was way back in the posts and had not seen Karin's response and quote from Missling that specifies 2A by the end of the year when I wrote this response, below. So I am surprised to find that it is only part A.
If you are talking about the request by patients and "carers" to extend dosing, then I don't think that extends the phase 2. In the Australian news article(s) the doctor in charge of the trial says he expects results by the end of the year.
It would still be good data that I hope could be used down the to beef up safety if not efficacy data, but I don't think it would extend the planned phase 2. Unless he was only talking about phase 2A finishing by the end of the year. But he didn't say that. In fact, he sounded pretty clear that he meant the whole phase 2,
"The final results of the study, which will involve 32 people in total, should be known by the end of the year.".
Maybe so, but the expected pop for Biogen on positive Phase 1B news was $18B. That's $128/sh or more for AVXL depending on how you compare Biogen's share count to Anavex's share count.
Now that was the predicted pop by CNBC, who may have been pumping the stock, so it might be an exaggeration... but if it was a 28% exaggeration... that is $100/share for Anavex.
Your right... not gonna happen. Not gonna get to an $14B fully diluted market cap... but on paper, it could. Please do check my math.
Yeah. Read the book, then later saw the movie. Loved them both.
Everyone? Even Algernon and Charlie?
I should be careful not to go overboard here. I could cost somebody money. It doesn't matter if my math is right or not, the market might not do what makes sense. We will know more in a few days, not weeks, is my guess.
And who knows. Your TPIV might rebound in spite of what I told you. It did recently rebound from about .55 to .85, before relaxing again. Then again, that could be it's last gasp until news about the Ph 2.
But I am very very happy with my very overweight position here with AVXL, regardless of what it does in the short run. This news from Australia is just fantastic and forms a tremendous, solid bottom, far above where it is now sitting. Eventually. I think soon.
Thanks Bud! Market Makers: Pretty different from what I thought they were.
So what defines a "Market Maker". Does that mean large enough to cause huge ripples but under the 5% threshold that restricts trading for penny stocks?
Perspective / proportion: I'm sure this is a threepeat at-least, but a week ago, it was less pursuasive.
http://www.cnbc.com/2015/07/17/has-biogen-found-the-goldilocks-dose-for-alzheimers-drug.html
7/17/2015
---------------------------------------------------------------------------
"A $10 billion swing for Biogen shares?
The answer could be meaningful not just for medicine, but also for the stock: Somaiya estimates Biogen will trade down 5 percent if the 6 milligram efficacy looks similar to the 3 milligram, but could trade up more than 20 percent if it looks like the 10 milligram. If it falls in between, as he says most people expect, he estimates the shares could gain 5 to 7 percent."
---------------------------------------------------------------------------
Biogen Cap was $95B. 20% of $95B = up to $19B swing anticipated on good interim data from their phase 1b trial. Their trial is much larger and more formal than Anavex's, but the $ being talked about are enormous. So even at a very small fraction of the anticipated response...
Call AVXL shares outstanding half way between fully diluted and posted / undiluted... 100M shares. A $19B cap would be $190 per share if the trial was as formal as Biogen's. So what fraction of that due to Anavex trial being less formal and with less patients? 20%? If so, that would be $38/sh on positive results at the end of the year, only 5 months away. That is a 58 bagger from the price right now.
But that is a completed small Phase 2A (Anavex) vs an interim large Phase 1B (Biogen). So 20% may be very much an underestimate. Net Net: AVXL could go to $100/sh by the end of the year, and much higher if an early approval follows.
Well you just keep waiting for $56 there bud. It's coming.
My hat is off to, Alexandre Vamvakides, Tangui Maurice, and Christopher U. Missling, in that order. I really like Missiling, but the actual inventor(s) have to be respected, even if they are currently a pain in the patent. They did a very good thing inventing this drug and probably worked thousands of long hours doing it.
It is possible they already have an arrangement with a big pharma, but that is an unknown. BP has allowed other companies to do trials with their blockade inhibitors as adjunts, without having to partner for the trials. So maybe it is not that big a deal. Just don't know. I would ask around. Also, will they have to redesign their Ph2 if they add the blockade inhibitors? They have approval for their Ph2 trial design... does that include the blockade inhibitors? Probably not. So they would probably have to start over negotiating with the FDA.
The current Ph1 data just says they generated T-Cells. The data says nothing about actually effecting the cancer. So while their products could be fantastic, there really isn't much evidence yet.
Unlike Anavex 2-73 that has patients and caregivers asking, "Can we have more, please sir?"
I don't understand the need for the Anavex-Plus patent. I have asked Christine to explain.
If a company came up with a drug that cured cancer when you take it with Aspirin, then they wouldn't have to patent the combination if they could patent their new drug. Example, NWBO, IMUC, AGEN have all patented brain cancer treatments that work a little better with SOC chemotherapy, Temador. Temador just went generic, just like Aricept. I don't think any of their patents were on the combination. The FDA approvals will be... but not the patents.
A doctor can prescribe drug combinations. They do it every day.
There is an advantage to patients and to Anavex to have a single pill. It is easier to remember to take a single pill than two pills, particularly for an Alzheimer's patient. And, Anavex could make money off of both drugs if they have a patent on the combo and doctors prefer to offer it as a single pill for the reasons stated above. So these are benefits to the patent of Anavex Plus... but they are not requirements. There is a requirement for a patent on Anavex 2-73, of course, but I don't see any reason why they have to have a patent on Anavex Plus. Maybe your buddy at Seeking Alpha can clarify that.
Yes, Circa posted the same. You are probably many posts back... of course.
When they announced a poster at AAIC it was hard to gauge how important that could be. If there are 100 posters by people in phase 2... then they might not stand out much. I tried to find a list of posters/abstracts, but couldn't. So I just searched through clinical trials and found quite a few. Left not knowing if anyone would even notice Anavex.
So to see them listed as one of just three significant data releases at AAIC is just incredible. Alongside Eli Lilly and Biogen! Wow!
Eli Lilly: MC 91B
Biogen: MC 92B
Anavex: MC 49M
Hearing about the Australian articles yesterday, I thought that England, Canada, and China might be watching, maybe more than the US. A lot of money in England. A lot of investing money in Canada. A lot of people period, in China. And Australia is pretty significant itself.
Anybody trying to sit on this is going to fail and lose a lot of money in the process.
I sold a little stock yesterday because it all gets more real as you near the event. And there was an earthquake the night before... expecting the big one on the same Hayward fault someday soon... but bought that small percent back this morning.
A week from now I will be selling a little to pay my internet bill and buy food. That is how deep I went. Literally everything. Not leveraged... I grew out of that... but I am still a gamblin man. I just got scared. I think the same for TT. Not setting anybody up. Just honestly scared. That is why I defended him/her?. Mostly wanted to be sure I was stable enough to not get shaken out of my main position regardless of what they threw at us.
As you or cdbpotential said, this is as much a poker game as anything else... most of the time (not when you get major results, but most of the time) and TT being open is a good thing. He was just being honest. He wasn't setting anybody up, and neither was I.
Is TT a really tall Dallas Cowboy or a Dallas Cowboy chearleader?
You are aware that TPIV needs a blockade inhibitor. They will probably need a big pharma partner to provide it. That is not completely under their control.
After staying above $1 for more than 10 days, they have now gotten all they can out of the funding agreements... the conditional warrants. So they are funded, but their drugs are not going to be effective without blockade inhibitors. Glenn Wilson is aware of this and has stated this in his presentations.
""At the request of the participants..." Honestly my favorite take away from today BY FAR."
And this is the doctor reporting this. Not a PR for a stock. Huge difference in public perception. People reading the PR might wonder if the reported request for an extension is really the company spinning the need to extend the therapy, hoping for efficacy to improve. But hearing it from the Doctor... it is clear, that is not the case. This is the inside poop. This is the kind of stuff AF tries to uncover... hoping it is bad. Maybe he called them or got word of the Australian articles and found out the straight poop is really really good. And that shut him up, or at least caused him to babble incoherently!
This is really good sht maan!
Wow Circa! Those Australian articles are going to make a big difference! To hear Anavex describe the good results vs the doctor at the site... it is a huge difference in credibility; particularly for outsiders new to the stock. And those are the people that are going to be adding big $, not us few fans.
Thank you Ziggy. I had only been looking at Yahoo finance. They don't list any shares short. I found the OTC site, and it looks like about 5M shares last time they tallied. That is a lot of shares... but at todays volume it isn't so much. 3 Hours to cover! But there might have been a lot more shorting since that last look June 30.
Thanks Drano, Yeah I am aware that the automatic purchases have been going for quite a while, I just wasn't sure if that was what AF was talking about.
AF is off his game. Doesn't make sense that he would be so full of it. You know I don't know if it would even be illegal if the CEO had just set it up. I don't think insider trades are illegal per se. I think they just have to be above board, and insider info can't be leaked to individual outsiders. I think you can trade on insider info. If so, AF is doubly full of it. Kind of bazaar.
I agree J-Luke. If that is what AF was talking about, then that is a very good sign. He usually has something disturbing to say about any company in his sites. He's got nothin.
Hestitant to post AF's tweet, but I need help understanding it. He is accusing the ceo of improper insider action.
I don't understand whether he is talking about the twice a week, automated small buys that have been going on for a while or some stock purchase means that does not show up on the NAS insider charts. I can't imagine he's moaning about those automated purchases. That is as open and clean as you can get.
"Uncanny how $AVXL CEO 10b5-1 trading plan knew to buy stock 1 week before #AAIC2015 press release. You’d think the darn thing was prescient."
What is a 10b5.1 trading plan?
Thank you Erik. What about the big dogs that might use AF or the Fing squad at Fierce Biotech, or that basher/dodger that posts from China... would they get involved with shorting such a small cap in a big way?
It may be useful to always be aware of the technicals, since as you say, there will always be a group of people trading off the technicals. And if a number of things hadn't aligned here to create the perfect storm, I would pay more attention to your numbers... but I think those things did align. We'll have a better idea about that over the next few days, not weeks, is my guess.
I don't know if the usual bashing by the usual suspects will happen with this stock. I think that bashing gets nastiest when the hedge funds have shorted a stock heavily, and positive sounding news comes out. That is when those hedge funds go into panick mode. This is a penny stock, so I don't think anyone can short it. Maybe try to slow it down while they (and their buddies) turn their big cruise ships around to head our direction... but not the kind of panick aggression that comes with potentially unlimited losses in massive, uncapped shorts gone wrong. But I am a mid to short timer in this realm. Particularly the penny stock realm. Just my best guess.
I just think this is a small cap biotech binary event which is likely discontinous, breaking away from the charts.
Maybe good advice, but I suspect these chart stats are pretty meaningless at this point.
I see 4 points of resistance in the awsome future, and none have anything to do with your technicals. They are all much beyond the numbers you are talking about.
Off the chain!
I agree TT. This year there was a delay after ASCO before most of the stocks I was watching started to lift. I got the impression that fund managers were sitting down in meetings and discussing everything they saw before deciding where to put their $.
This PR in and of itself could be ignored by some. But combined with negative reports from competitors and technical reports suggesting that this is the next most likely direction to go in... there is every reason to believe the implications of these relatively informal results and reported patient + caregiver feedback.
I managed to get all my shares back today without a loss... and a few more. I only sold a small percentage yesterday.
Another reason why shorting the stock wouldn't make any sense...
because this is a non-margin(able) stock. You can't short it. Oops! I knew that! Guess nobody is reading what I write... or you are all very polite.
Further, I have always thought that another walk-down technique is spending some effort, ie selling some shares at the right time to walk it down a little until people with margin panick and sell-off. And if the manipulators keep the price down long enough, they have to sell off.
But you can't margin this stock... so that whole issue is moot. That might shift the odds a little in our favor relative to previous experiences with margin(able) stocks.
I sold a little today too TT. In fact, exactly the same percentage. I am way way in, and the reality is that even with great results there could be a short term dip. That dip could come from manipulation by BP's to attempt to keep the stock/co soft for acquisition, or who know what reason. But if the results are really good, the dip can't last long. The market is too big. I just wanted to be certain I was on solid enough ground to wait it out if necessary. There is the seeking alpha article likely coming to the cavalry in the short run, more data releases, and the full data release for phase 2 not that far off. And the potential upside is absolutely enormous.
Of course there might not be any dip. If the results are even decent, it would make no sense to short the stock with similar results likely coming along the way to the full data release in 4 months. And those playing the run-up should be out by now. And I don't know if these guys are yet on anyone's radar, including the BPs.
And I agree with all the arguments that the data will likely be at least decent if not fantastic.
It seems that an additional 1% for Anavex Plus on top of 6% for the component Anavex 2-73 is very generous, yet reasonable. A good compromise. Is it possible this issue is totally resolved with that number, and that Vamvakides is no longer contesting the issue?
Vamvakides was made chief science officer as part of the original patent(s) purchase, and provided a salary, albeit a small salary. He's not chief science officer any more is he? I wonder if the relationship with the company degenerated, and he was booted. I wonder if that is the source for the negative energy driving his efforts, if those efforts have persisted.
7% is a big percentage given the drug potential and the amount of time and money required to realize that potential. But maybe it is not so big compared to the amount of stock given senior officers... maybe that is what pained Vamvakides.
My dates for the time it took the USPO to process the -371 patent were again errored. I am not going to write the new dates for fear of screwing that up again. But it apparently took a very long time to process that patent. Maybe they lacked key docs in that case also along the way. Still it is true that the time that has expired since the -273 patent power of attorney etc docs got cleared up is not long enough to be any indication of a problem in getting the -273 patent. I have recently read that 12 to 18 months is typical for patents. Not sure if that applies to pharma category patents.
Thank you WWayne, especially since I misstated the patent application date (year) for Anavex 2-73 in an earlier post. You cleard that up and a lot more. I have to be more careful.
The correct dates show that the patent approval process has taken much longer than the approval for 3-71, which only took 11 months. That is concerning without your DDiligence which explains not only why it is taking so long, but that all issues that have caused the delay are now dead issues. There is a new start date to the application process, and the period since that new start is only 9 months, somewhat less than the time it took for 3-71 to get approved. So... no reason to be concerned. There could be problems, but no indication of that from the timeline. Please someone correct me if this is not right.
Regarding 2-73 Plus... it is not clear to me whether Anavex is trying to prevent Vamvakides from getting his 6% for the 2-73 used in Anavex Plus, or whether Vamvakides is trying to claim ownership of Anavex Plus. If the first, then I doubt that Anavex will win, and I don't think they should, nor do I see that as a big issue. If the second, then I think Vamvakides is deluded. I agree with what others have said about that.
Thank you WWayne, especially since I misstated the patent application date (year) for Anavex 2-73 in an earlier post. You cleard that up and a lot more. I have to be more careful.
The correct dates show that the patent approval process has taken much longer than the approval for 3-71, which only took 11 months. That is concerning without your DDiligence which explains not only why it is taking so long, but that all issues that have caused the delay are now dead issues. There is a new start date to the application process, and the period since that new start is only 9 months, somewhat less than the time it took for 3-71 to get approved. So... no reason to be concerned. There could be problems, but no indication of that from the timeline. Please someone correct me if this is not right.
Regarding 2-73 Plus... it is not clear to me whether Anavex is trying to prevent Vamvakides from getting his 6% for the 2-73 used in Anavex Plus, or whether Vamvakides is trying to claim ownership of Anavex Plus. If the first, then I doubt that Anavex will win, and I don't they should, nor do I see that as a big issue. If the second, then I think Vamvakides is deluded. I agree with what others have said about that.
For a "wash sale"; the way I remember it is that you can't count/deduct the loss in a wash sale right away, but it changes the cost basis for the stock so that when you do sell the stock you are taxed on less gain. It just changes when you can count the loss, not whether you can count the loss.
It used to scare the crap out of me, but I no longer worry about it.
US Patent Application for Anavex 2-73: Anavex is "Original Assignee", which is reassuring. Would be more reassuring to have the patent in hand... but looks like the patent application was only filed last July.
http://www.google.com/patents/US20140296211
And below is a reply from the Anavex interface staff regarding questions about patents.
-------------------------------------------------
Thank you for your email and interest in Anavex Life Sciences Corp. (OTCQX: AVXL).
Comprehensive patent applications have been filed. These are for composition of matter and use of ANAVEX 2-73 independent of the previous inventor. However, there are no concerns since Anavex owns all intellectual property irrespectively.
The attached files lead to Anavex’s pending U.S. patent applications and issued U.S patent. Some applications have corresponding international filings. All pending applications are being thoroughly pursued.
U.S. Pat. App. No. 13/777,471
“Sigma-Receptor Ligands with Anti-Apoptotic and/or Pro-Apoptotic Properties Over Cellular Biochemical Mechanisms, with Neuroprotective, Anti-Cancer, Anti-Metastatic and Anti-(Chronic) Inflammatory Action”
Not yet published
Identical to parent U.S. Pat App. No. 12/522,761 / U.S. Pub. No. 20100069484
U.S. Pat. App. No.14/205,637
“Sigma(s)-Receptor Ligands with Anti-Apoptotic and/or Pro-Apoptotic Properties, Over Cellular Mechanisms, Exhibiting Prototypical Cytoprotective and also Anti-Cancer Activity”
U.S. Pub. No. 20140228375
U.S. Pat. App. No.13/940,352
“Anavex2-73 and Certain Anticholinesterase Inhibitors Composition and Method for Neuroprotection”
U.S. Pub. No. 20140296211
U.S. Prov. Pat. App. No.62/065,833
“A19-144, A2-73 and Certain Anticholinesterase Inhibitor Compositions and Method for Anti-Seizure Therapy”
Unpublished
U.S. Pat. No. 8,673,931
“Bicyclic Heterocyclic Spiro Compounds” (ANAVEX 3-71, previously AF710B)
In addition to the existing portfolio, positive clinical data and novel molecular chemistry studies both completed and underway are considered avenues for additional proprietary protection, which are being currently and actively pursued.
Please do not hesitate to contact our office if we can be of further assistance.
----------------------------------------------------------------
The significance of the adaptive trial with EEG and biomolecular indicators.
For Anavex 2-73 plus they have two drugs to coordinate in trying to nail down dosage, etc.. That is 4 times more difficult than optimizing for a single drug, not two times. If they had to wait six months to get feedback on the efficacy of a given dosing combination, then it would take a very long time to cover a wide range of possibilities. If they don't cover a wide range, they could miss the optimum (they might optimize to a local optimum that is not the global optimum). These tools for quickly detecting efficacy make it possible for them to move very quickly toward an optimum combination for Anavex 2-73 plus. They also help to move faster for evaluating Anavex 2-73 itself.
I don't think the tools even have to work super well for them to assist in this effort. They just have to work fairly well.
They probably have a pretty good idea of the needed dosing, but it is smart to cast a wide net in the effort to catch the optimum before launching a phase 3. I don't see enough of this kind of thing going on. This rings true and it rings smart.
At least that is how I recently started to see it.
.48, .49, ... 22 min ago: https://www.prbuzz.com/business-entrepreneur/338019-neuronetrix-to-gain-significant-exposure-with-key-alzheimers-stakeholders-at-aaic.html
Looks like Anavex might get some extra press from these guys at the upcoming conference. That is... in addition to their own poster presentation.
Cool "Entry Signal".
Another correction. They do have to report soon, not another month. I was off by a month. But I don't see any ownership changes yet on the NASDAQ reports, nor any related SEC filings for any of the stocks I watch. Soon.