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4.20 STINKY GREEN BID!
Hit me fellas...awwww shucks!
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I agree. Without him at the helm I don't think we would have come this far.
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Negatives?
*Lack of partnership could mean 100%+ dilution for financing.
*A2-73 may not demonstrate enough statistical improvement in cognition and function over the SOC to be approved.
*Sigma-1/mixed muscarinic compounds may not succeed on the whole as a viable class of therapeutics.
*Long term use may lead to serious AEs and safety concerns which are not apparent yet.
*Sufficient IP protection may not be achieved.
*Market forces may succeed in crushing the spirit and perseverance of the company.
*90% of neurological drugs fail in advanced trials.
On and on and on. It is an uphill battle against seemingly overwhelming odds. We get daily reminders of that.
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Your corrections and clarifications are most welcome. None of us have the time to master all the info so the group effort is invaluable. Thanks to all who contribute in a meaningful way.
XenaLives: I think the scientists believe treatment in the earliest or even asymptomatic stages and the prevention of irregular proteins is the key path. This makes early detection and biomarkers critical to establishing a long term effect. A larger trial with a large % of very early/mild diagnosis' would certainly have some element of mis-diagnosed patients in the arms.
I think if 27 to 32 of the P2a patients make it through three full years on the drug any outstanding averages in the results will be undeniable proof of efficacy. The 2 year extension, being part of the "possible" paths, depending on results, makes the 3 year dosing regimen part of a successful long term strategy.
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Fortunately, I think you're preaching to the choir!
2-73 and 3-71 are different compounds. A2-73 is a pro drug for AE37.
http://chem.sis.nlm.nih.gov/chemidplus/rn/195615-84-0
Nice explanation in your post #61917. I doubt they are taking two months to try and mine data from a 32 patient pool.
The 5 week data was N=30. I think adding 2 patients is delaying full 12 week data for N=32, and yes, someone wants the PK data double-verified before funding further development.
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A2-73 has been in development longer. We have only had rights to A3-71 for two years.
http://www.anavex.com/?news=anavex-strengthens-alzheimers-pipeline-obtains-exclusive-worldwide-rights-to-intellectual-property
I think they would be rather combative, in the scope of receptor affinity being the key component of the cellular process.
There was a lot of work that was done before Missling came aboard. It would be folly to abandon that. He is a wise manager of resources, IMO. It would appear the company has no desire to partner out compounds during early development and subject them to BP bureaucracy. They don't run efficient, adaptive trials as that does not support their agenda of economic influence on the system through user fees.
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html
http://www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/#765efcbc7908
As you can see we are garnering more non-profit support. Expect to see Dr Missling aligned more with these public-interest groups and less with BP. When NPs see the grant monies of others going to extremely good use they tend to pile on.
I applaud Anavex in supporting the saviors, not the starvers. Go little redhead!
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I went ahead and ordered the docs. NYFA! §
Discussion should ensue regarding Muscarinic acetylcholine receptor ligand selectivity and new therapeutic compounds. Heptares claims safety concerns with current (AD SOC) drugs which activate M2 and 3 receptors are alleviated by it's M1 and 4-selective affinity compound(s). It is unclear the speciffic affinity that A2-73 has for these receptors, but the data would lead me (scientific moron) to believe it has affinity for the M1,3 and 4. I believe A3-71 is more highly selective toward the M1 and 4/5 exclusively. Without digging, I believe Dr Fisher has provided better clarity on the subject regarding A3-71. That is why I believe A3-71 is our real powerhouse monotherapy and the meat at which we must use A2-73 as bait.
Still, I think Hepartes is on the right(est) track and we should be ascertaining what the specific affinities toward the Mx receptors are and watching how they work. I sent the company a memo outlining my desire to see some of this information outlined in future publications. Please help George in explaining how these Mx receptor affinities are so important and how Anavex has the perfect platform for delivery.
I also think Dr Missling knows all about this and it is the preamble to his arrival on the Anavex scene.
Thank you,
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Then what happens to this:
Outstanding Shares 111,042,787 a/o Dec 31, 2015
They just reversed the entries. The preferred stayed the same, the common A/S was increased from 150MM to 400MM for all the new shares that will be hitting.
If it was the preferred raised to 400MM (which would be ludachrist) then the common just reverse split 1:3. Doubtful, with insiders holding 70%.
Dilution bro. That's what's coming. The pop last month was the goods.
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I think all three session participants are presenting updates on their trials. vTv's will likely be an enrollment update. Biotie just got bought in a tender offer and may have preliminary data.
Anavex's title "ANAVEX-2-73, a Sigma-1 Receptor Agonist" is wide open. It could be AD data, PK preclinical, both, none, just a presentation on the MOA...who knows? Exciting, yes?
It will certainly be ugly if we don't get the 12 week data and no excuse why. There will be no sugarcoating at that point.
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I thought that too George. From the presentation, I read between the lines as:
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Key Achievements to Date and Expected Catalysts in 2016
1- New 104 week extension study of Phase 2a after PART B
HAM-D added as SOM - could boost long term quality of life assessment
2- Preparation for Phase 2 study in Rett syndrome Double-blinded, randomized, placebo-controlled
I think the IRSF will/help fund the P2 in preparation. It's kind of obvious with the rapidity of development.
3- Preparation for Phase 2/3 study in Alzheimer’s disease Double-blinded, randomized, placebo-controlled, Potential for first registration study
Our suitor awaits the IP.
*Present at three scientific meetings in 2016
This could mean clinical development updates. PK preclinical, epilepsy trial plans, A3-71 P1 BABY!!!
*Phase 2a – Report PART B data at scientific meetings once data available
Yes, we better get the 12 week at CCS!
*Phase 2a – Report PK/PD data once data available
Yes, we could get this via 8K in a morning PR, like all the other bios do. You know what happens then!
*File IND for non-disclosed indication
This is the Retts. Disclosure happens when the co announces the IND is filed/approved.
*Complement current pipeline through in-licensing – ongoing
This is the part everyone that says 'Missling has said partnership' is talking about.
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Three cheers for Team KEYO!!! It was a pleasure to serve on the board. Wishing everyone the best in all their future endeavors. See you after the shell gets bought...down at the lake!
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Yep. Time to cover and go long...yawn §
Then will you be reporting, or staying under threshold?
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Hey nice find! I had been wondering when they would get around to updating the 002 study record with the new extension info. This is even better, as it technically gives us two listed trials and the P2a can now be listed as completed, with results, after October.
It is making more sense why we are waiting longer than anticipated for the 12 week results, if the first enrolees did not start the two year extension until March.
Observations on Extension Study:
*The enrollment stands at 32, meaning they added two patients after the CTAD 5-week report of N=30. This alone can easily account for delayed 12 week results for the cohort.
*POM is safety. 2 years without any grade 4 or 5 AEs, even in just 32 patients, would be powerful.
*They added HAM-D to the SOMs. Was this measure of depression added to help help empower the outcome?
Enjoy the party...I sent a plant!
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How about that for a long silent period reason? The co did announce the CCS event much farther out than usual, I thought. Perhaps withhold certain catalysts until the fed can get him under control?
I'm the worst for reading too much between the lines.
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Part of this could be construed...
"Assistant U.S. Attorney Winston Paes said the new charges, which would be filed within 30 days, involved alleged securities fraud and a crime related to a February 2013 "PIPE" transaction, or private investment in public equity, in which private investors buy a company's shares outside of public stock exchanges."
http://www.cnbc.com/2016/05/03/prosecutor-shkreli-may-be-slapped-with-new-charges.html
Message board amusements turn into real life drama? Oy Vey!
Cheers!
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Oh that's too much. I hope this doesn't turn into a distracting media spectacle. Shrkeli Black vs Missling White!
Wavelengths man, wavelengths!
Thanks for explaining that. It is sure to be a topic of wonder. Did you see DR V's app got the non-final rejection a while ago? How about Missling/Durrant listed as inventors?
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Excellent post! Your timeline seems reasonable to me. FDA could halt for efficacy, or want full results because of the long-term nature of the treatment. There could be other treatments approved before then that temper the urgency. So many variables. 09/17/2018 is my guess.
Website has been updated with Annual Meeting, CCS and BIO 2016 events. I am unable to make the meeting this year.
BIO 2016 - Dr Missling is listed as a panel speaker. I don't know if he is giving a corporate presentation though.
https://mybio.org/profile/member/603949
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"Weismann said that CREW hasn't received any response from the SEC or the U.S. Attorney's Office regarding the complaints.
"It has been a wall of silence," she said. "We make these kinds of requests on a regular basis, and often times the SEC will call and want more information, but this time we haven't heard anything."
http://finance.yahoo.com/news/martin-shkreli-defended-biotech-shorting-153000807.html
Might could be!
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Might need to clarify that this is an application and not a granted patent.
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016064711&recNum=1&maxRec=&office=&prevFilter=&sortOption=&queryString=&tab=PCT+Biblio
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I am under the impression an indictment is handed down within 90 days of subpoena. But yes, that chicken has not hatched yet.
Shkreli posted being short AVXL and that leads to believing the subpoena has to do with him and/or the Nov attack, which certainly did not look like legal trading. His charges in the Retrophin case are unrelated. It will be interesting to see what these new charges might be. Illegal shorting? Headlines about that and mentioning AVXL would be interesting for us, for sure. Imagine if illegal shorting of AVXL in particular was at the heart of it.
It would be nice if none of it was happening but it seems to occur with every promising company at some point. Just like the media hype.
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No, you got it right. I think he may be deceased. I've had a sneaking suspicion for quite some time. It would not change the course of things, I'm just curious.
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A commendable effort. Makes this board great. Thank you! §
He hasn't been Chief Science officer since 2010. I emailed IR the question and will report any answer.
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A normal timeline. The application was filed 10/19/2015. It is a combo therapy like the PLUS app. A WIPO patent is preferable to a US only patent.
Here is my updated list:
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Anavex IP Portfolio:
GRANTED PATENT:
U.S. Pat. No. 8,673,931
“Bicyclic Heterocyclic Spiro Compounds” (ANAVEX 3-71, previously AF710B, composition)
U.S. Pat. No. 9,180,106
"Sigma receptors ligands with anti-apoptotic and/or pro-apoptotic properties, over cellular mechanisms, exhibiting prototypical cytoprotective and also anti-cancer activity" (ANAVEX 2-73 Method of use, cancer)
PATENT PENDING:
U.S. Pat. App. No.13/940,352
“Anavex2-73 and Certain Anticholinesterase Inhibitors Composition and Method for Neuroprotection”
U.S. Pub. No. 20140296211 (ANAVEX 2-73 Method of use, Alzheimer's Disease)
WIPO Pat App No.WO2016064711
U.S. Prov. Pat. App. No.62/065,833
“A19-144, A2-73 and Certain Anticholinesterase Inhibitor Compositions and Method for Anti-Seizure Therapy”
Provisional (ANAVEX 2-73 Method of use, epilepsy)
UNPUBLISHED:
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 (ANAVEX 2-73 Composition & Method of use, cancer?)
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The company could PR the preclinical epilepsy results along with this associated patent app this summer.
Thank you Dr Thomas!
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ANAVEX 2-73 Epilepsy patent hits the world stage:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016064711&redirectedID=true
Misling/Durrant listed as applicants. I fear what I had suspected is true and Dr V is no longer alive. I did not think Dr Durrant was involved anymore. This is interesting!
http://www.anavex.com/?news=anavex-appoints-dr-cameron-durrant-executive-chairman-of-the-board
Fabulous news on the IP front!!!
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It's been way past 90 days since the subpoena and now clear to the market that the company was not the subject of an SEC investigation.
How's that CA suit going Karen? Does this latest entry indicate Judge Furman intends to expedite the matter?
https://www.pacermonitor.com/public/case/10241340/Cortina_v_Anavex_Life_Sciences_Corp_et_al
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ed- and hfb46 too. Bravo!
Perfectly stated! §
That is the risk-reward here. We can't even say it all depends on the black and white of the drug working. Many drugs that could have reached approval do not because of mismanagement. Having confidence in the management helps overcome some concerns such as dilution. Dr Missling has inspired and deserves that confidence, IMO. Financial planning is his forte.
Do you really think a potential first class AD drug will go to a pivotal trial without industry support?
Like cbd says...Patience, Perspective.
Proud to own Anavex and take this risk!
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Correct. It has been dropped. I sold my scrapples @ 10 & 9¢
GLTA
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Good find. Extremely dilutive financing on the way. All pump posts of last 3 weeks negated. The .06 to .15 was optimal. 20% rule, as usual.
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An inclusion would be nice validation. More than I would expect at this still early stage. Missling's performance record would soar to ~+160% at that mark. Quite impressive, IMO.
Notice only half the share traded on the 25th have returned to the market?
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His holdings as compared to affiliate/institutional reporting over the period equates to his moderate position. It has nothing to do with whether he bought or sold. It's an equity stake ratio. If I reported, it would skew the data and you would pay more for you shares. It is part of the market process, to withhold stakes.
Don't belie the game. Stakes are high. but take your good profits. You can always re-invest.
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Who's they? Us? I'm an owner, this is my bitch. No, she's not indexed on any exchange. Not yet. AVX is...fwiw
http://www.marketvolume.com/indexes_exchanges/r3000_components.asp?s=RUA&row=250
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It would only reach that on a fundamental collapse. Don't be left sitting at the table then. Certainly not doubling down! The ocean is full of fish.
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Great info F1ash. That is typical accumulation for index fund managers in a non-indexed junior exchange issue. I look forward to an index inclusion. Game over.
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