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Rather than saying "this company" I should have said whoever was the owner of 2-73 at the time. I'm not trying to point a finger of blame at the wrong people.
He very well could be disappointed he didn't take the deal since back then there was still time left on the original 2-73 composition patent which is now expired. It's a real shame not only for AD sufferers but also for long time investors that this company (under bad mgmt) frittered away much of the last 20 years without being able to get 2-73 to market.
What's going on is most likely aggressive shorting IMO. The last short report covered the period when the stock had run up a couple of bucks ($4->$6) and instead of showing a decrease in short interest (covering) it showed a big increase. The shorts apparently are not afraid of this weekend's update. From their point of view it's probably just a percentage play.
It is strange to see the aggressive shorting before the conference. Could simply be a somewhat automatic reaction to the big recent stock price rise. Also could be they think a rehash of "The n=32 is too small to take this seriously" short argument will work. The only other argument I could see them potentially try is patent related. If the data shows that Anavex-PLUS is no better than 2-73 then they may complain about the lack of a path to patent protection for 2-73 as an AD treatment. (Of course they'll neglect to point out the 5 year FDA exclusivity grant for 2-73 for AD.)
The problem I have with that "one two punch" roll out strategy is that it invites AF and others to induce a bear raid if indeed the 12 week data is lack luster. I know they have conference rules to abide by regarding pre-release of data but I would hope they could say something on Sun to hint that the 12 week data is not indicative of a plateau or roll-off. There's no point in giving AF and friends several days to poison the well.
"I'm waiting to see how tomorrow AM plays out"
That doesn't sound very reckless ;)
He's only guilty of insider trading if he trades AFTER getting the info. I agree that he does not have the data.
AF uses a schtick against his target companies which is to treat small "n" phase 2 trials as if they're pivotal trials that are failing to show statistical significance. In order to avoid criticism from AF in a phase-2 you'd have to avoid any reporting of efficacy until you get to the pivotal.
Did he say he went short after seeing the data? If he didn't trade AFTER getting the data then there's no insider trading violation.
Question on international drug approval and exclusivity (if any). Does FDA approval and the 5 year exclusivity granted by the FDA get mirrored at all outside of the US? Exactly what happens outside the US if 2-73 monotherapy was approved for AD? Since the original 2-73 patent has expired and since there is no 2-73 monotherapy "method of use" patent, does this mean that as soon as 2-73 is approved for AD in the US, drug manufacturers could start marketing 2-73 for AD overseas (assuming the target countries don't require their own trials for FDA approved drugs)?
Outstanding post! A couple of questions...
You said re: A19-144 "It’s effectively at the same stage of development as A2-73 (being the metabolite of A2-73)."
Are you inferring that the fda (for approval purpose) accepts testing of 2-73 as testing of A19-144 and both will get the same verdict at the same time?
You said re: A19-144 "...then follow up a few years later with A19-144 combination therapies for Alzheimer’s"
What intellectual property related advantage does a "combination" therapy off of A19-144 have over a combination off of 2-73? Each would be just as patentable as the other, correct? I don't understand the A19-144 advantage in that scenario.
What I don't understand is why Anavex never went after a method of use patent targeting AD with 2-73 alone. Was that not possible according to some issue with patent law? I've tried to read the abandoned patent application and the multiple claims submissions and corrections prior to abandonment and it looks more like a first attempt at the current melanoma patent than a simple method of use for AD using 2-73.
"Or maybe no BP is willing to invest on an n-32?"
or maybe BP's want a longer duration of exclusivity than just the 5 years the FDA grants to a new drug.
What's the last day that notification of late breaking could be given to a participant?
You may be right that it's the same but as someone who lurks on the Yahoo board I can tell you the ridiculous pumping hype that helped push the stock to $14 back then is not there now. Sure there's a pumper or two but NOTHING like the campaign to pump the stock back in November.
But her relative is only one person. We know that this drug is probably not going to work on some people and will have different levels of efficacy on those who do respond. If Ms Australia reports her relative is better than at the start but does not see a "playing the piano again" level response, how do you know the reason is not that they were one of the low responders? Her relative alone is statistically meaningless.
LOL. There's a guy on the Yahoo board trying to explain the patent
situation and is getting flamed right and left. Amazing that not one (other) person over there has a clue what they're talking about. You'd think at least one of them would have followed what has been said over here.
and it's up particularly big today (June 30) because last year June 30 was the day when the company announced "late breaking" status which confirms the importance of what is going to be presented.
Agreed, and I will try to avoid speculating. I only went down this path of looking into the patents because when I emailed IR to ask about the duration of protection for the composition of matter for 2-73, they pretended that I simply asked them for a list of current patents and they sent me the list. When I emailed them back letting them know they did not answer my basic questions on expiration they never responded to any further emails. I found that very irritating and non-transparent.
I'm new here and have not focused any attention on 3-71 so I don't know where it should fall in the priorities. These are just my thoughts as a pharma neophyte so take my comments with a grain of salt. *IF* the combo competition has to go through full FDA phased testing then I would guess they could not come out with a product while 2-73 is enjoying it's 5 years of exclusivity thanks to the FDA. If 2-73 alone becomes the standard of care then I would assume any combo drug would have to beat that standard which would be a much harder task than Anavex faces in beating donepezil. I would think that a combo pivotal trial would be much more expensive, time consuming, and require many more test subjects to be able to definitively show a difference between the combo and 2-73 alone. As I said, take this with a grain of salt.
If a competing combo drug has to go through all the normal phases of FDA testing then it would take a lot longer to get to market than 2-73. We are far along in the process.
"Orveko has pointed out that A2-73 is currently protected by one patent related to its use as a combination therapy for the treatment of melanoma, but that does not protect 2-73 as a mono-therapy. "
Ok, that jives with what I found out researching the composition of matter patent which expired back in February. I guess that expiry motivated MediSynergics to go after a 2-73 combo. If the results at this conference cause 2-73 to get huge boost in notoriety we may see more companies going after combo drugs with 2-73. I would guess the possibility someone could now take 2-73 and make a combo drug that could exceed the efficacy of 2-73 or 2-73 PLUS adds complexity in dealing with a big pharma potential partner.
Thanks for that info. I enjoy following the process as well and am trying to learn how to do my own DD on patents. Tonight I've been poking around the Greek patent site (www.obi.gr) using the patent list from the Anavex Edgar filing from 2007 that detailed the purchase from Dr. V. My question is regarding those 3 Greek patents. The first patent 1002616 looks like it's the definition of 2-73 and gives the instructions for how to make it. The other 2 patents which are later in time I'm not sure what they do or how they may or may not extend the protection of 2-73 composition. I'm assuming one or both of those are the reason why the consensus here is that 2-73 composition still has a few more years of protection. I'm trying to understand where that comes from. When I look at the base 1002616 patent application I see an application or filing date of February 21, 1996 which is obviously more than 20 years ago. Also when I look up that patent using the following obi link (http://www.obi.gr/obi/?tabid=127&idappli=X2593) it confirms the patent expired this year on 2/22/2016. This has led me down the path to understand how the other two patents related to 2-73. So far I have not found an english version of those.
I know this is all old stuff probably discussed ad nauseam on this board a year or more ago but if you know of any particular posting(s) or user-ids I can search on to dig deeper on this please let me know.
Forgive my lack of patent knowledge but how can MediSynergics get away with using 2-73 in its application? I've gone back and read most of the excellent patent discussions on this board going back about a year and as I recall the consensus is that Anavex has a few more years of protection on the 2-73 molecule itself. If that is the case then MediSynergics would have to get permission from Anavex to use 2-73 correct? And of course there's no way Missling would agree to that. It seems to me the only way MediSynergics can get their patent is if the original patent on 2-73 has already expired and the composition of matter is no longer protected.
Patent question for orveko_inc or other patent experts.
(This may seem like an obvious question but I'm new here and have been wading through all the outstanding patent DD posted here in the last year.)
Is it true that in order to extend the original 2-73 patent for use in treating specific diseases Anavex *MUST* combine 2-73 with some other substance and the result *MUST* perform demonstrably better than 2-73 alone for that particular disease?