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Thanks for noticing, and pointing out, that subtle detail(s) in the radio interview (much appreciated)...and BTW I thought it was very well done by the Doc...
a deal with the mta partner is huge from a perspective of advancing the credibility of avxl: The shorts have always fed on this weakness... I thought it was a huge vote of confidence for management to offer a mta testing agreement in the middle of their AD trial .... sort of like, here you go , go try this out and you will see.... actually amazing and they had not even done much with MS on 273 at that point.... Now if in fact I am correct and the Preferreds are for the mta partner this will add massive credibility for 273 and would show how well founded managements confidence is..... hard to believe the market has not reacted yet also, even if still not confirmed..
MTA agreement at 6 months March 28, likely the partner had to make a decision on whether to execute next segment of contract, and did..and this ties up the finer details of 273 study (especially PK/PD etc)... We may get some top line 273 data, which would be nice, then again it also might be tied up... I am thinking that it may have been the partner who requested the poison pill so that none of their competitors can come in the back door.... and yes the preferrereds would be for them...
didn't buffet say that "in the short run the (bio)stock market is a manipulation machine but in the long run it is a weighing machine"....or something like that...actually I think he said voting machine in the short run......but he was thinking blue chips....ps I knew they would take it down today...
If the Insomnia data is correct, IMO what has changed is now we have a very promising pipeline, in multiple indications CNS and other, with stellar results to date, very innovative promising science, but also a big financial cushion (by reversing insomnia in AD) to lower downside risk, and more important, where the cushion is actually a spring board....since what would be the value of the cushion (40% to 100% penetration in AD?)....
IF 273 cures insomnia in AD patients then it follows that 273, as a minimum, should be either used in combo for all AD patients (since its safe and cures insomnia), or in conjunction with any other approved treatment, for the segment (40%) having insomnia.... So what I am saying is that if the data on insomnia is correct (100% correction of insomnia in AD) it follows that 273 should almost certainly get between 40% and 100% of the AD market penetration, in a worst case scenario (where it is found ineffective in a p3 trial to help AD....)
The above assumes 40% of patients of AD have insomnia.... and with this reasoning IMO... it looks like we know we have a winner, of at least 40% to 100% of the AD market...
AVXL must retain insomnia rights....no one can afford it?
What maybe $1 Trillion.... more than the GDP of almost all countries....Whats that per share ... don't even look....
Insomnia: the long effect of metabolite (when added to the synergistic initial effects of 273 on sigma 1 and m1 and S2) ....likely key to insomnia: This is a hypothesis worthy of consideration... makes sense ... long lasting effect equals....sleep well....
re: insomnia
100% cure rate ... ya thats a signal....
and if insomnia ..... signal already there .... insomnia alone, if further proven , could be as big as aspirin.....
Avxl has to be very careful how they do any partnership deals .... and do not throw in huge value alongside main deal ..... as a free grab bag (where grab bag is worth as much as main deal)...
2011... by Dr. Maurice on the metabolite...
ANAVEX 19-144, when administered prior to amyloid 25-35, protects against amyloid 25-35-induced amnesia in mice.
ANAVEX 19-144 protects against amyloid 25-35-induced oxidative stress, measured by lipid peroxidation in hippocampal cells.
"It is hypothesized that cholinomimetic-only compounds would not have as much benefit as the mixed mechanism of the aminotetrahydrofurans, which may be potentiating. Interestingly, the pro drug and active drug effect of ANAVEX 2-73, which has ANAVEX 19-144 'embedded' in it, may offer a longer duration of action," said Dr. Tangui Maurice, PhD, CNRS Research Director, Team II Endogenous Neuroprotection in Neurodegenerative Diseases INSERM, University of Montpellier, one of the poster authors and a member of the Anavex Scientific Advisory Board. "Histological evidence is powerful visible evidence of neuroprotection and this study also reinforces the anti-amnesic effects already described in this animal model of amyloid toxicity benefit with aminotetrahydrofurans."
"We are excited to have had this, as well as a poster on ANAVEX 2-73 and a potential dual role in amyloid and tau, accepted at such a prestigious event as AAIC," said Dr. Cameron Durrant, Executive Chairman of Anavex. "These neuroprotection data may translate into clinical studies as we continue to explore disease-modifying approaches with our novel family of compounds and the lead small molecule, ANAVEX 2-73. It may be potentially beneficial to have a further positive effect on top of ANAVEX 2-73 in the form of its active metabolite ANAVEX 19-144.
North America.... eom
Thats also what I think ... they are likely IMO holding back avxl any way they can right now...trying to get a big deal done ... I am guessing though that the new CEO, trying to prove himself ,may actually try this tactic too strongly and risks missing out..... I am predicting one of two things...that either a big money deal gets done in NA, buyer takes all, (with some contingencies is fine) in the 12 B to 16 B range .... or failing that that a smaller offshore deal gets done (but for non NA rights) ... leaving NA to be pieced out based on indication rights , later when the time is optimal for avxl....
avxl secret sauce of moa restrained:
why would they contain details on the moa finer workings: simply for proprietary reasons ... likely other companies ar as we speak trying to imitate the moa .... many companies patent certain aspects of their tech (that they do not mind being revealed) and then just keep other aspects secret ... a combo approach on the tech IP sometimes could be the best....
Insightful post .... I have always thought the fact that the 273 metabolite (forgot what they call it) is also a sigma-1 agonist, (but with some different characteristics compared to 273, I think) could likely be an important element in how the drug acts....providing a double hit if you may...
Our Doc was recently quoted as saying his main responsibility is to "ensure trials are designed to succeed".... It is fairly easy to extrapolate from that and conclude he does not have much (or any) time to baby sit what the stock does (especially day to day)... It is interesting now that somebody came out today and complained about the long delays for getting p3 going... pretty funny .... We are still running p2 and data still coming in, and likely well into PLANNING (i.e. Doc is focused so it will not fail) P3... The complaint about delay is targeted towards what the author knows is a huge weak spot with retail investors (Patience) and nothing else , since fundamentally the complaint is "meaningless"...
The other complaints about finances and fringe science do not even merit a rebuttal IMO (as they are so weak) and again only targeting what the author perceives as weaknesses within the psychology of retail investors... If any retail succumb then it likely is good overall as they should not be into bio investing IMO....
yes exciting ... but i have a feeling someone will be begging them not release data next week ... lets see who wins... money talks I guess...
March 28th (next week) will be 6 months since the MS MTA agreement was announced... but the agreement could have been signed days before as not contract details were given... Also 6 month length of contract is my guestimate... but 6 months is a nice round number and should have been long enough ...and why would avxl grant a longer period if it was not necessary for testing... Lets see if the partners new president has the ability to lead ....
avxl also has to be extremely cautious (as someone else mentioned here today) that none of the various indications run into roadblocks like what happened at Mannkind .... there is much less risk of this happening if they piece out the indications to specialists and back things up with strong contract law on such things as performance..... and for those that are adamant that they want it all .... better look at what Gilead paid for hep C..... if they pay up big they would then have to commercialize the indications for financial reasons....
I think the world does work like that MC (generally I like your ideas) ... do you think the partner would walk from a very reasonable deal on MS only franchise, if they thought it worked, AND if they thought it could get into the hands of an MS competitor of theirs? All they have to say is yes we are ready now to do a deal on MS ... other indications are not at deal stage yet...... (without saying the implicit (take it or leave it and at your peril)).....
Insomnia huge market, easy to test for, we have the signal...
This has me intrigued .... the easy to test for really is exciting IMO since we have the signal already and it will likely be further confirmed either at any of the upcoming CNS trials -- or could Insomnia just be tested in a (regulation friendly) small jurisdiction on a batch of patients, a non-FDA trial , almost immediately? and then followed up as necessary for an OTC (or RX) approved insomnia pathway?
Proven safety and ease of testing (with a salient signal shown) almost seems to good to be true....
It may be in the interest of avxl to not give the mta partner any further info (and therefore the market also) until after that deal expires....
BTW I would give them the 273 MS franchise by itself, at a very reasonable price, almost as a loss leader in a deal, but NOTHING else from 273 or 371... Summary: do not give them any CNS rights...... except 273 for MS....but give them that very reasonably... why give away insomnia in the huge bag of side freebies... Tell the partner by virtue of their work on MS they will always have a front seat at any rights licensing tables and there will be lots of time for that in the future......
My guess is the MTA partner initially wanted all of 273 and as a bare minimum a first right of refusal on 371 if any deals on 371 are offered ... I suspect now they are wanting more (both price and terms),,,
Could be they were a bit too sneaky with the mta agreement and now have avxl slightly tied up until their time to analyze expires (and also have upset avxl)... Could be playing hardball with avxl on terms and details as we speak and the sneaky aspects of how it is unfolding may explain it not being mentioned today. and the push for the poison pill, trip to Japan, German co opening etc..... Just my gut instincts speaking...
Not sure yet if a takeover is real situation or just precautionary planning by avxl.... but if real and happening now this should be a good lesson, when concerning a strongly undervalued company like this, the bad decision making for those placing stop loses or following gospel teachings of self described experts trading between the resistance tracks...
I see your point but it depends on how management views this partner and their relationship....and terms of course .... 6 months is not a long time to have things tied up if they were careful to not expose themselves behind that .... in a way it shows their confidence in there product , and also who they want to do business with...
MTA for 273 answer to questions IMO...
I have a strong feeling if we could read the material transfer agreement many questions being asked would be answered... If you were pharma what kind of clauses would you want included to enable you to do lots of research, have ample time, and then be able to execute on the contract, on the original terms?
I think until this contract expires (hopefully 6 month term) or is executed on, there may be a hold back on some 273 info...could be why 371 being worked on more now (i.e. its not in the contract terms)... PKPD maybe also be held up... in fact most questions asked here have a simple possible explanation in the MTA .... I think avxl may have went hard on price but gave some slack on soft terms...and this may have them ham strung a bit short term....
drug $ cuts force BP to scramble for new tech:
The gov has a lot of control over generics, and ensuring more competition in the same ... this is fairly obvious. For RX drugs, the gov can still lower them as well by showing what they sell for in other countries .... this will cause drug cos to raise RX prices internationally and lower them in the states... Stateside generics will drop significantly overall, and RX will drop but less than Generics, stateside..
So how will leading pharma companies counteract this ... by embracing innovation (read chasing), and hopefully being a leader, in the development of new proprietary drugs (where they have more pricing power and no competition) that can benefit society ... This will be a huge tailwind for avxl and other bio cos that have promising new tech to benefit the healthcare system...times are changing...
there is a strong case for that argument
innovative platform tech positive to health reforms....
avxl fits in this category, and eventually the market will get this simple fact... ... it was a FUD shake piggybacking on worries over reforms... I think a shake (or shakes) here is perfect timing ...we need stronger longs and maybe less retail in this stock...
this shake on FUD is probably good for logical thinking longs who have done their DD .... down on low volume is reveiling.... the shake is good because we need weak longs (and weak traders) to leave this stock ... The LPC financing has been gone over in detail over a year ago and is an ok deal ... whats important is how many trials get going and how many shares are issued to achieve that (end of story)..
P300 elec. result first ever at 52 weeks...
Placebo talk is out of control as we have enough data (through hundreds of failed trials) to show that the effect is minimal in AD, and the very small reflect (at shorter time frames) can be adjusted for (but p300 needing NO adjustment) ...For the benefit of patients and saving costs i would prefer no placebo but avxl has stated there will be a placebo in p3.... I think they state this just to satisfy traditional thinkers.... The P2 p300 results back up the idea of a tiny (or no) placebo...So how much would a trial cost in Aus for 150 medicated and 10 on placebo... and would this be partially or fully subsidized...
Electrical P300 great results... and positive correlation to others...
"The P300 wave amplitude showed a small initial increase from about 6 microvolts to 7 microvolts by four weeks, and then returned to about 6 microvolts until about week 32. Thereafter, it steadily improved to about 8 microvolts by 57 weeks—a level usually seen in healthy age-matched controls. There was a significant separation from the P300 decline seen in a matched historical Alzheimer’s disease cohort, which decreased to about 4 microvolts over a 52-week period while patients were taking donepezil."
Note that a placebo has zero to no benefit in sorting out p300 ....could the FDA look at this and decide avxl only needs a "tiny" placebo for phase 3 (or better even none)... and therefore save even more money in the p3...
I had been thinking the same....highly probable...
hacking? inside employee offside? etc....
IMO no.... just that someone pointed out that on their web site avxl is not shown as a partner ... where they were before....
noticed Ariana head science director was previously employed by Pfizer as a scientist, has several patents in her name for biomarkers.... Wonder if there was some concerns by avxl about info confidentiality with Ariana, and had to sever the tie after their work was complete ....
1000 paths of a hostile takeover attempt:
-18 months ago the rumour was AXON since they were considered both evil and possessed cunning and leading edge knowledge of stock trading from foreign jurisdictions, Naked shorting, using offshore nominee accounts, and on and on.....IMO this could be the biggest risk and I dare say a level of knowledge (and evilness ) above our management M&A experience.... My gut feeling is that this group would have no problem getting around the 5% ownership rules using offshore nominee accounts and their very unique skill set... Maybe a a BP would piggy back on Axon (or Axon itself) and then just sit quiet with majority control and let the current management run things (until after phase 3 or approved NDA)...
Yes agree 100% but also the "small" or "Tiny" n is used very similar..... 1) Placebo and 2) small n, are both IMO a complete manipulation in how they are used to discredit.... Notice also that the intent is to point to that the data is invalid .... but interestingly the same people who raise these two points then go on to vigorously debate the finer detail of the data... I find this situation revealing .... in other words, if the data is invalid why all the effort to debate negatively what the data points to... I actually like hearing negative viewpoints when they make sense..