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Pozen has staked its future almost exclusively on a new combo drug that enables users to take aspirin daily ) as a preventative drug for heart and other potential illnesses) without the side affects sometimes caused by regular aspirin usage ....bleeding of the stomach...
I think it's MC is about 600 million... and the Asprin combo drug is called Yosprala (spelling?)...
Actually you are incorrect ..many take aspirin daily for Cardio preventative measures....google it...
New diagnostic testing is being developed, this is the expertise of some on the avxl SAB and also some trial testing partners focus in this area, , if the disease can be detected much earlier (before significant plaque has built up, the 273 alone will likely be much better than the combo for this large early detection possibilities.... Additionally, and on a different usage , if anti-inflamation and neurone operational health leads to better brain function then 273 used alone for a brain health pill could be a reality....
Good thinking Xenalives....I was thinking along similar lines and yes could be Takeda or Otsuko (both into the dementia market and even have some knowledge with sigma 1 receptor science..... The other possibility offshore I was thinking could be a deal with a Germain company for Western European rights..... IMO also these deals do not have to be much more than selling exclusive marketing rights for their markets.... IMO with science results thus far, either of these two markets distribution rights . could be sold for sufficient funds to finance a P3 trial ... and in my opinion AVXL can retain full control of the 273 in AD world wide except they would be committed using them as a distributor only , in their defined market (or expanded as negotiated)..... I think Missling will get us a good deal....
MF (and Todd and CN) exposed yesterday as suffering from severe "Group think" syndrome causing severe blindness to actual results .... It is obvious in reading their pieces that their brains cannot get around the idea of how BP after spending tens of billions failed, and a co that spends tens of millions succeeds... rather than study the results their brains are sidetracked (by the idea that a micro cap can not steal the prize from BP) to the point that logical analysis is impossible, they are jaded from the beginning by this idea ...... yes it is a form of group think....
IMO the 273 plus patent is not as critical (being delayed a bit) as many have said here... An issued patent is not required for 273 plus to commence P3; and if approved Anavex can sell 273 and Aricept , separately (and I think even combined in a single capsule) all while waiting for the patent (in the unlikely event if it takes a long time to be issued).....Lastly, as I understand also, their current 273 patent will protect them in either scenario with both selling 273 alone or with aricept.... The only reason I was thinking the 273 plus patent is valuable is it helps them to isolate the AD market, from open label sales and partner AD separately from the other Dementia indications by not having 273 sold individually in any indications, to very much limit (or completely eliminate) open label sales ...
could a squeeze of shorts (including naked ones) be happening...
Shorters hair will get thin..eom
if you keep trying, you will may be e correct half of the time, very short term, and incorrect all the time, long term... but also remember unlimited potential losses being short.....so for example with $25,000 short you could loose $250,000!!!!!... if a buyout came in at $3 Biillion out of the blue with no notice or warning...... just like that...do you feel comfortable trying to get investors to take on that level of risk...
"While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames[color=red][/color].”
Dr. Orrin Devinsky.....
My hunch is based on purely circumstantial info... as follows:
#1) It was revealed today that he knows all about AVXL.; and
#2) one of his mentored students, now an expert in epilepsy is none other than Dad of Marc and Max....
So there is no proof, but I was thinking what are the chances of the two conditions above being true, and assuming the two consulted on the topic and Devinsky not being invested?...
"Devinsky's epilepsy research interests include translational therapies, sudden unexpected death in epilepsy (SUDEP), devices to deliver drugs directly to the brain, quality of life, cognitive and behavioral issues in epilepsy, surgical therapy, and new medications. Other areas of active interest include autism, tuberous sclerosis, and head trauma.
Devinsky serves as the director of the Phenome Core for the Epilepsy Phenome/Genome Project, funded by an NIH multi-institutional grant. Devinsky and his co-investigators are conducting studies of several investigational antiepileptic medications such as topiramate, tiagabine, lamotrigine, vigabatrin, oxcarbazepine, and remacemide, as well as vagal nerve stimulator implantation. He is also collaborating with other researchers to develop a device to deliver antiepileptic drugs directly to the brain to treat seizures.
He was involved in pivotal drug studies for felbamate, oxcarbazepine, intravenous valproate and other drugs. He was the lead investigator of the Quality of Life in Epilepsy group that developed the four inventories that were translated into many languages and used in over 150 academic studies.[2]"
The individual "I have a hunch" may meet that description has written 350 papers , authored 20 books on epilepsy, been on tv many many times as an expert, and I think interviewed
Obama on specific healthcare issues...
What do you think it would do or signal if the top epilepsy doctor in America was long, and very bullish AVXL?
connect the dots....
Phase 2Aa/b human AD trial results to date, have a confirmatory stamp to the amazing epilepsy preclinical trial results ..... that could/should power an epilepsy partnership...
"I would bet money that ANAVEX will be doing Phase-2 trials in 2016 for both Epilepsy and Parkinsons. Besides a Phase-3 for Alzheimers with Anavex 2-73!! Think about how much that will impact share price. Great times around the corner!!"...SA commentor
and add to the above progress on 371.......
They likely are designing pivotal trial now, they have the leading experts for this now on their SAB, and they already have approval to start this so they are not waiting for anything that I know of...Once the trial is approved, hopefully prior to that the 273 plus patent has been granted which will also increase the chances of partnership being in place ...although given the severity of the disease and results to date many unconventional long term or bridge financing sources could be available (for example even the FDA will finance certain programs) , making the partnership a non-issue as far as the pivotal getting started (although longer term a partnership is likely advantageous) ...so in a nut shell , although many moving parts are involved, on the pivotal, it looks like things should be in high gear getting planning done with a goal for quick commencement of the trial...
Why Epilepsy looks as likely to succeed as AD (Simple):
-preclinical trials for epilepsy were the strongest AVXL preclinicals;..
-strong data from human AD phase 2Aa clinical trials supports epilepsy hypothesis
(and indicates Epilepsy preclinicals were very predictive).......
Hooperg ...Thanks again. I am totally amazed at the quality of your contribution here....When you speak it is transformational....
If there is room for responses in the sticky section here, I would vote for the Heeperg reply ...... especially if SA does not accept it...
Thanks hooperg.... Your analysis here of the most recent AF piece, is most aooreciated...
"While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
This has me thinking, with the quick effect on working memory, by how much could this potentially shorten clinical trials ? i.e. "shorter time frames"? Could this mean a 3 month phase three, then approval with an ongoing extension parallel to the approval?
A lower price helps BP for both negotiating partnership or friendly buy outs...I am not thinking a hostile take over but a lower price would help that also.... and while the poison pill would help ward off a Hostile Take over, it still could happen easier than you think ... If they own 30% of votes before the PP, then after the rights offering from PP, they would still own 30% and that may put them in position to have a reasonable chance to take over...A PP only helps if the hostile target is an outsider...
TOB... IMO if it was driven by short trading motive they would not have came out with the hack piece on Nov 9 , hours after the AVXL news; instead a pure shorter would have left it pop for a week or so first... a few other decent clues also that point to accumulation at cheaper prices (and imo attempt to hold down for buy out)...
swing trading looks easy... but be careful as at some point soon almost all the swing traders will be left on the side lines... BP and pharma finance do this all the time..this is nothing new and they know exactly what is going on with retail...also they are experts at NOT allowing repeating trading patterns after retail sees an obvious pattern.... there is a reason successful pharma have few retail...
Also George Dr. Maurice, a sigma 1 world expert, and co-lead most of the 273 pre-clinical trials, speaks very highly of both 141 (little discussed) and 371 as both very high in future potential!!!!!!
Cartel is worried: BP interested in AVXL:
The talk of Biogen and EL yesterday made them worry, and the attack is their feeble effort to try to scare off BP.....they are so easy to read...
BP, like investors, are also targets of Soft basher speak....
I noticed they keep repeating over and over how BP will be prudent and wait for future de-risking before making a move....Which is crazy and any Business Development officers from BP that believe this crap ,better polish up their resume.... as if they miss moving on an obvious excellent opportunity with much more than ample compelling evidence, based on manipulative basher angles, their BODs will be looking for BD replacements.....I also concur with the idea that NA BP , unless they are smarter than I think, may get manipulated (by the likes of some low life pharma persons) out of the pole position on AVXL, very much like happened with Avanir, and with AVXL Germany could be a possibility..... The NA BP that will have a chance, will be those that are capable of doing their own "in-house" DD, trust their own findings, and do not need meaningless, and treacherous wall street confirmation...
Turing Pharma/MS mistake on drug Daraprim $750 pricing:
Seems Turing forgot that Daraprim is a generic compound made out of two simple drugs which are also generic....so it is simple to copy Daraprim...without going through an ANDA filing and now anyone can compound Daraprim.... which is the drug Turing wanted to sell for $750 per pill...
"Express Scripts Holding Co. said Tuesday that it will make a treatment for the rare infection toxoplasmosis that costs $1 per pill available on its biggest formulary, or list of covered drugs.
Daraprim, the drug that costs $750 per pill, comes from Turing Pharmaceuticals, which stirred outrage among doctors, patients and politicians when it bought rights to the pill earlier this year and then subsequently jacked up the price. The 62-year-old drug had been priced at $13.50 per pill before that.
Other drugmakers have also recently purchased the rights to old, cheap medicines that are the only treatment for serious diseases and then hiked prices. The practice has triggered government investigations, politicians' proposals to fight “price gouging,” and heavy media scrutiny.
The Express Scripts decision means that a cheaper alternative to Daraprim created by Imprimis Pharmaceuticals will now be available to about 25 million customers through its formulary. What those customers pay will depend on their insurance coverage. That could mean prescriptions that come with a co-payment as low as $10 or $20 for the whole bottle of pills.
Express Scripts manages pharmacy benefits for customers like insurers and employers. It makes recommendations on drug coverage, and those customers can then customize the guidelines.
Toxoplasmosis is a parasitic infection that mainly threatens people with weak immune systems, such as HIV and organ transplant patients, and pregnant women, because it can kill their baby. Express Scripts says only a few hundred of its customers were treated last year for the infection, but the company is always looking to remove wasteful spending from the health care system.
“We believe we now have a safe, high-quality and extremely cost-effective way to provide access to a Daraprim alternative,” Chief Medical Officer Dr. Steve Miller said in a statement from the company.
Imprimis, a 3 1/2-year-old drug-compounding firm based in San Diego, had said in October that it will supply capsules containing the ingredients pyrimethamine and leucovorin as an alternative to Daraprim.
Mass-produced drugs must be approved by the Food and Drug Administration. Imprimis, like other compounding pharmacies, instead makes up individual prescriptions using drug ingredients already approved. In this case, that involves combining pyrimethamine, Daraprim's active ingredient, with leucovorin to limit pyrimethamine's side effects.
Express Scripts and Imprimis said Tuesday that prescriptions for the Imprimis compound will be processed starting later this week."
Very wrong .... Naked Shorting was 70% of the power behind the drop, the coordinated bashing and hit pieces and fraudulent articles and and social media was the other 30% or so....but the planning and coordinated timing of everything at a point in time (which was also a positive news time) was powerful also...However without naked shorting AVXL would have went up Nov 7 and would be above $15 now.....
lower tier shorters getting fryed today... the ones who try to ride the coat tails of the
JC/AF cartel coat tails...also some BP getting fryed on funds they put up to naked short use by the cartel (the cartel would not use their own money for the last/lower more dangerous part of the short, likely they would use their money to naked short say down to 10, and then use suckers money (probably greedy BP) that they control to naked short from there to bottom and also help from retail and wannabes).....
If you are a BP liking the potential of the Sig 1 and M1 receptor science......well now AVXL has not one but the two leading drugs in this category... It makes the company even much more attractive as a buy out or partner target for them... and not to mention the SAB that comes with the two molecules...!!!
would "Priority review" be an additional...
Please note the exciting thing about the recent study results was many of the patients were already on DZP so that the increase in positive results over baseline , could only have been Avanex. In other words the patients had already achieved any benefits from DZP they might have.... Now couple that with the fact that past Ad trials showed almost zero placebo effect, and that the next P2B/3 pivotal trial will likely use DZP as its placebo arm, and we can infer what those results will be like...
also in they past they said they expected a rare disease IND in the second half of 2015 --I am wondering if this could be on Dec. 7th?
great post and also to add: What is the pair trade with a short of AXON? I think a long in AVXL... since both are Alzheimers target companies ... short the weak, long the strong on same indication...BTW this alone, if picked up by the Hedgies could bring in far more investment than all the combined retail interest combined to date IMO...
Yes I think they will partner the indications separately ....and actually it would be an amazing extra boost in value, having AD and Epilepsy both as optimized combo drugs, so they do not compete against any other drug off label, or each other.. Also with Epilepsy, I am wondering if they might have three separate drugs....since they had three combos that showed strong synergy...and since epilepsy is very complicated with many patients differing from one another, the combo that works best for a particular patient may be different from patient to patient...So this also begs the question, would they run three separate Epilepsy trials concurrent ...I think so, and likely with the same trial design...
If you think about all this is becomes evident why they retained an in house patent attorney...
Thats is why I was asking about Parkinsos, because it looks like both AD and Epilipsey will be combo treatments, and if Parkinsons is also, then there would be three combo treatments which would eliminate the risk of "off label " sales, and make it easier to licence them separately.... If only Epilepsy and AD were combos, and if necessary Parkinsons was with straight 273 ...even with this structure, you could still licence the three separately to different BP, with minimal risks of off label sales .... as most would go for the convenience and stronger results of the combo vs purchasing 273 off label on Parkinsosn, for AD and Epilepsy...JMHO
Looks like Merck makes Sinemet ... the number one Parkinson drug ...not sure yet if it is available as a generic...