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"His statement about IP being under control could easily mean he is confident that the Plus patent will be approved"
My recollection of the origin of that comment is that it was given a long time ago when ownership of a particular patent was in dispute with Dr. V. He was basically saying Anavex owns the disputed IP. I'm not sure he ever repeated such a statement with a broader context (such as patent coverage for AD treatment).
That begs the question of why the patent examiner and Anavex lawyer bothered to have a phone conference discussing needed dosing details if the "obvious" argument is still rock solid and insurmountable.
"FDA IP protection is adequate"
Adequate for whom? Apparently not for a BP to give Missling a P3 deal he can accept or there would have been a deal by now. Until I hear a better explanation I'll stick with P3 being delayed until the Plus patent attempt is concluded.
I would think this isn't the first time the patent office has had to deal with the combination of two drugs that bind to the same receptors (for example in the area of depression meds). If so then it's surprising that neither the USPTO nor Anavex's lawyer has included a precedent in their "obvious (or not) to anyone skilled in the art" argument.
I used the term investing in the traditional sense of letting a fundamental story play out. THAT is what I call investing. If you want to call short term trading to increase gains part of the "investing" then we just differ on the definition of the word. The context of my remark was the assertion that HFT and manipulators makes stocks uninvestable. That's only true if your holding period is much shorter than the time frame of the fundamental story playing out.
and once there's plenty of positive unambiguous data published, the opportunity for gains in this investment may be many many times smaller than it is today. If you want lottery ticket sized gains there's no way around the risky situation of very limited data.
I read it. I'm no lawyer but it looks like Saunders did his homework citing precedent where he could. I dont understand the particular rejection based on the argument that anyone skilled in the art would combine the two drugs expecting additive results. Why would it be additive if they compete for the same receptors? That rejection is responded to in this update and Saunders is basically challenging the examiner to support his view... from p4 of Argument/Remarks.. "Applicant invites the Examiner to support this conclusion with a declaration under 37 CFR $ 1.104(d)(2)."
Does the examiner have to give a "supported" argument? I assume a final rejection (by this examiner) could be appealed to some higher level examiner(s) where they might be sympathetic to the company if there's a lack of depth to that particular argument by the current examiner.
I see updates under the Image File Wrapper dated today.
"In a market that is totally rigged via HFT and other algo manipulation is ANY stock investable? "
Absolutely, but many think "investing" is holding AVXL for 2 or 3 or 6 months without flipping it. That is not "investing". Nothing stops a stock including AVXL from going to a fair price IN THE LONG RUN. HFT is about getting in orders a split second ahead of other orders and it amounts to computers flipping for pennies, not driving a stock relentlessly down or preventing it from rising. IN THE LONG RUN either Anavex gets a drug approved (or more than one) or it does not. If it does it will have earnings that will force the stock price higher. If it does not react to earnings then the earnings can be plowed into dividends and THAT will force the stock higher. Real earnings never lose.
Looks like someone turned on the 100 share robot manipulator this afternoon.
"IR told me Anavex 2-73 is under patent for many years to come. They referred to a patent, but I think it was for the patent specific to melanoma."
If you want a specific answer for patent coverage of a particular use such as treating Alzheimers you have to be VERY specific with your question. If you asked "Is 2-73 under patent" they will answer "yes" as long as there is ANY protection for 2-73 in their current patent portfolio. Since they currently do have a "method of use" patent for 2-73 treating melanoma, the answer to your broad question is "yes". If you want to know specifically if they have protection for 2-73 as a mono-therapy for AD then you have to ask them that specific question. I have done so several times and the responses (or lack thereof) I've received has lead me to believe that orveko_inc's patent research and conclusions were correct. No point in repeating his detailed research in this post, anyone can find it if they want to, just google his id.
(I decided to come back since a late cleanup was done to a particular chain).
I wasn't going to make any further posts since this afternoon did not sit well with me but since you addressed me I'll take it as an opportunity to wish all longs here the best of luck and success. I currently hold a good chunk of stock which will get bigger if the Anavex-Plus patent is issued. I wont be making any further posts on this board.
The partnership he can get should be dramatically better if he has a product with ~20 years of US protection and potentially similar protection pending in other countries rather than just 5 years of US protection.
The thing that's frustrating is there are other companies who are just as far (if not a lot further) away from proving their case to the FDA but enjoy much higher valuations even though their approach is in the same general direction of countless past failures.
Call me cynical but I don't think the "news" media is deliberately ignoring Anavex. The supposed "news" media is now almost totally agenda driven selling "narratives" as evidenced by the fact that most of the preeminent talking heads of the TV news media were listed in one Podesta email as being "reliable to sell a narrative". The only narrative they're interested in selling now is a political one and they're hammering it 24/7 with little time for anything else unless it involves shootings, explosions and mayhem.
I'm not sure why he would finalize a deal until he knows the final verdict on the Anavex Plus patent. He has a much stronger bargaining position with it.
Question on combo drugs and how they are administered. Lets say a company gets an FDA approval for a combo drug 'X' + 'Y' where 'Y' is already approved but 'X' is not. Is the manufacturer required to produce 'X' + 'Y' in only an inseparable form (i.e. 'X' + 'Y' compounds must be mixed before being made into a pill/capsule/injection etc.)? I assume so but was wondering if it's possible they could sell an 'X' pill and a 'Y' pill packaged together with instructions to take them together (which could be ignored by those wanting to take only 'X").
re: "next trigger"
If the company is waiting on resolution of the 2-73+donepezil patent application to determine if the P3 will be for that combo or something else then approval of that patent could be the trigger in terms of P3 partnering and execution. Seems like from yesterday's postings on that patent, the company only needs to provide more dosing information to match the broadness of the claims.
"Kinda contradicts when Missling says there is no patent issue"
Correct me if I'm wrong but when Missling originally said that a long time ago he was specifically addressing a patent in dispute between Anavex and Dr. V. I don't think back then it was intended as generic statement saying they had no patent "coverage" issues with 2-73 for AD.
Xena, good post but just how far does data exclusivity go? Specifically how is it that generics can way under price an original drug if the generic maker has to take their candidate through the same testing and submit their own data? They should have all the same costs to recoup?
Off-label question for any docs here. If 2-73 were approved for one of the orphan indications (and it became widely understood that 2-73 works for AD) could docs use it for AD even without the FDA approval for AD?
"What's wrong with 5 years exclusivity?"
Nothing, if you don't mind other drug companies racing to get the drug to market outside of the USA right after approval. Also, evidently the 5 year exclusivity has not been enough of an incentive for a partner to give Missling an acceptable partnership deal. He was talking in late 2015 about seeking a deal. Here we are a full year later after releasing lots more data that could have been given to a potential partner early under non-disclosure agreements.
My hope is that the latest patent application (filed in November) is a new 2-73 combo patent for AD using some undisclosed compound to replace Donepezil.
brichnyc, as discussed by a few of us yesterday, there are patent issues with 2-73 as a mono-therapy treatment for AD. That's why they went hard and heavy after a combo-therapy patent using 2-73+Donepezil and why this trial was mainly focused on testing 2-73+Donepezil. There was nobody better on this board than orveko_inc at unraveling the patent situation and I linked to one of his fine posts yesterday. (It's well worth anyone's time googling to find all his old posts if you haven't read them). I believe that is the reason this stock is stuck. It could be that the company could delay a pivotal trial for AD until they find a patentable combo-therapy using something other than Donepezil. orveko speculated a long time ago that if 2-73+Donepezil performed poorly or the patent for that combo was rejected, they might go after one of the orphan indications first to get a money making product to market and go after AD later when they come up with a patentable 2-73+???? combo that works. The question as yet to be answered is whether an FDA granted 5 year window of exclusive sales in the USA (but with no patent protection) is enough of an enticement for the company to go ahead with a pivotal trial now vs continuing to try and find a patentable 2-73 combo for AD.
Leo, I've never seen anything better on the "ambiguity" than
this July post by orveko_inc.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123725986
That patent protects 2-73 for the treatment of cancer. It has nothing to do with Alzheimers. Use the public "PAIR" link to look up the application number, then select the "Image file Wrapper" tab. Then click on the latest line that says "Claims". If you read the claims they say cancer specifically.
Sokol, Did you find out anything on that Nov 2016 patent application? I got nothing back from my email to IR. I didnt really expect a response since I found out that applicants are allowed to keep their applications a secret for 18 months after filing.
https://www.uspto.gov/web/offices/pac/mpep/s1120.html
"The company knows how much they need the combo patent, even if they know monotherapy is better. "
That's part of the reason I asked the question about how the FDA polices imported drugs. The FDA granted 5 years of exclusivity is only within the USA so what's to stop patients from getting it much cheaper from a Canadian source soon after it's approved (like they do for other drugs)? Can/Does the FDA currently do anything to actually protect drugs still inside the 5 year window from foreign sources?
Question on the FDA's ability to police generic imports...
We all know of people who get certain drugs from Canada because
they're much cheaper in some cases. How does the FDA know if someone
in the USA is getting their prescription filled by a Canadian company? If the FDA really has no way of knowing, how do they protect a US produced drug that has been granted a 5 year exclusivity?
I sent them an email asking for the appl number.
sokol, Without an application number that patent is hard to find. I've been trying for an hour using the usual USPTO web pages but have come up with nothing trying to find it by company name, inventor, etc.
"would other government agencies other than Australia's recognize the work"
Why would the FDA allow a Phase 2 in Australia and then not allow a Phase 3?
Steady barrage of 100 share buy orders at 3.94 and the ask never moves. Put in a buy order of 1k at 3.94 and they execute the trade at $3.9358. Fishy smelling.
"This is what happens when a company gets 8 million dollars and refuses to tell its shareholders where it came from"
Really? That would be like me making $8 million on stock and my wife leaving me because I refused to tell her which one.
sokol, you said "the U.S. FDA exclusivity only has application in the U.S. Therefore, the Greek patents have no relation to the FDA exclusivity, "
Yes, I understand all that. My point which was poorly worded was just that for the USA market, the greek patents would have to extend past the exclusivity period to add any value re: protection of AD treatment.
sokol, the original greek patent for 2-73 was granted in 1996 and I thought the others were granted a few years later? I would think if you add the current time for 2-73 AD approval + 5 years of FDA exclusivity, you'd be out near or past the expiration of all those Greek patents. Could there be any meat left on those bones?
Also regarding the dormant patent. I recall an old Orveko post where he was discussing why that patent had not been reactivated given it's relevance to the current trial. I believe he said the original patent was broader than just a composition of matter patent and that it went into "use" as an AD treatment. I believe he said that may be gating the activation of the dormant patent.
sokol, great post. You said "I have posted something like this before, but here it is. Anavex will have some form of exclusivity for AVXL 2-73 for AD alone not to mention the exclusivity it may have for all of the other uses. It certainly has 5 years FDA exclusivity in the U.S."
That is exactly my understanding as well. What do you think about that patent that was granted in 2015. I've been bashed over the head for saying it does not cover 2-73 as a mono therapy for AD. I'm talking about the patent with 16 claims that all say melanoma. What is your take on that patent?
Earlier this year I saw David Feherty's program on the Golf Channel where he talked with Peter Oosterhuis (famous golfer commentator) about his AD diagnosis. Feherty also talked about his own fears of AD since he has a parent with the disease. I looked up both of their email addresses and sent them links to Anavex. Never got a reply but didn't really expect one since they are public figures and probably get tons of emails on their public facing addresses.
The stock isn't going to hold any gains until the P3 funding issue is settled IMO. We were talking about how a deal was imminent one full year ago. Eventually you get to the point where it becomes clear that there isn't going to be a p3 funding deal for 2-73 as a monotherapy AD treatment perhaps due to the lack of patent protection for that specific use.
"Holding better than expected"
after falling from $6 to $2.
I wonder which hedge fund is going bankrupt because they shorted 50 million shares of this stock. To be a fly on the wall in that office.