Talon38 Latest Posts - Profile | InvestorsHub (2024)

As I said in my previous post.

Drs Messling and Kaminsky are shooting the last 3 at the buzzer for the 21st Century Rett Trial. Which will be watched very closely by the MJFF. Then they jump with both feet. An Aus only or a double arm AUS/US AZ Phase 3 is being carefully planned to start this summer on the heels of the Rett results. And off stage is Biogen with new positive results for MS.

This story is about to cascade very quickly. Partnership, B/O and or major funding from many private/pubic sources.

Don't leave your seats....they may not be there when you get back!

Re: the Bio CEO and Investor Conference.

Believe that if Chris Messling and Steve Kaminsky talk even anecdotally about a Rett Trial in their meeting then FDA approval and subsequent trial announcement is not far behind. Too much coincidence for them to be speakers in the same breakout meeting.

A feature of the Bio CEO and Investor Conference next week is their "One on One" partnering meetings.

The list of investors is quite impressive with Barclays, Franklin Templeton, Johnson & Johnson Innovation, J P Morgan, Maxim, Morgan Stanley, Pfizer Inc, Piper Jaffray, Roth Capital. Sachs, and Wellington Capital to name a few of the heavy hitters.

The word is getting around and I can just see a long line waiting at Dr Missling's table (into the night!)

Foo.

From the link you provided leads as you know to the Foundation for the National Institutes of Heath. Two of their current research programs are:

with a contact of Dr. Rosa Canet-Aviles. Already associated with this effort are AbbVie, GSK., Eli Lily and Biogen

funded and in collaboration with the NFL.

Looked at the BOD of the FNIH and several have Neuroscience backgrounds including the Chairman. Dr. Stephen Paul.

Jimmy

No offense taken. Remember, your 70's are the new 50's !!! I still run my John Deere all over my property. race my M3 at Laguna Seca, work out at the gym 4 times a week and generally try to stay two step ahead of dementia. Your genuine concern for those little one suffering from Retts, our military members and young athletes suffering from TBI/CTE and our parents, brothers and sisters suffering form the downward slide into dementia, heartens me.

Keep the faith!

Thanks Falconer,

A thoughtful and well reasoned reply as usual. I will forward my initial post to IR, aware of being overly helpful and understanding the Company's plate is over full with P2/3, Retts and Parkinson's. Will also explore passing Anavex's information on to Boston CTE Center, Dr. Gandy at Mt Sinai, Dr Slobounov at PSU's TBI Research Laboratory and the office for CTE affairs at the NFL.

Although, motivated by a bit of self interest as I am approaching my mid seventies and played football through high school, college and in the service (a bit of rugby too with no helmet!!) I have a genuine desire to see these terrible diseases effectively treated.

I see this board and its many engaged backers/owners of Anavex with the same kindred motivation. Accomplishing thorough DD and getting the word out is just a reasonable responsibility for we the active stockholders.....that we might receive reasonable ROI is an added benefit.

Another glimpse into the sad and costly face of Alzheimers which many on this board know personally.

https://www.washingtonpost.com/news/to-your-health/wp/2017/02/03/brits-spent-months-trying-to-identify-a-lost-alzheimers-patient-the-answer-broke-their-hearts/?utm_term=.c7c79614ff49

Falconer,

Would you care to comment on how CTE/TBI would benefit from the application of 2-73. The CNN article mentions the fact CTE/TBI are caused by externaliy inflicted trauma to the brain but appear to progress to the disease stage either causing Alzheimers, Parkinson's or ALS. The article also quotes Dr Sam Gandy, director of the NFL Neurological Center at Mount Sinai Hospital as saying, (Also from the Alzheimer's world there are hew drugs being tested to treat CTE -CNN) "Not only do we have the first ways to see CTE, we also have the first ways to touch it with a drug." (Could 2-73 be in the discussion?)

Boston University CTE Center - CTE Definition

"Chronic Traumatic Encephalopathy (CTE) is a progressive degenerative disease of the brain found in athletes (and others) with a history of repetitive brain trauma, including symptomatic concussions as well as asymptomatic subconcussive hits to the head. CTE has been known to affect boxers since the 1920s. However, recent reports have been published of neuropathologically confirmed CTE in retired professional football players and other athletes who have a history of repetitive brain trauma. This trauma triggers progressive degeneration of the brain tissue, including the build-up of an abnormal protein called tau. These changes in the brain can begin months, years, or even decades after the last brain trauma or end of active athletic involvement. The brain degeneration is associated with memory loss, confusion, impaired judgment, impulse control problems, aggression, depression, and, eventually, progressive dementia."

From Wikipedia on NFL players and CTE

"A cohort mortality study run by the National Institute for Occupational Safety and Health (NIOSH) examined 3,349 NFL players who played at least five full seasons from 1959 to 1988.[30][31] Findings showed that while NFL players lived longer than the average American male, the risk of death associated with neurodegenerative disorders was about three times higher among the NFL cohort.[30][31] The risk for death from Alzheimer's disease and ALS were about four times higher among the NFL cohort.[30]

The NFL"s use of 2-73 for CTE.

Brought this up in a post about a month ago but, the upcoming Super Bowl and a recent news item stating that Randy Cross (an all-pro lineman who played with Joe Montana in the 49ers glory years for you youngsters) announced that he had given permission for his brain to be studied for CTE after he dies, peaked my interest again. (Sorry falconer for the long run-on sentence!)

CTE is Chronic Traumatic Encephalopethy brought on by concussions suffered by players during their careers. The attached CNN article talks about the NFL efforts to combat the occurrence of CTE and various other agencies research into diagnosis and treatment. Interestingly, one of the entities mentioned was involved with Alzheimers/Dementia.

Certainly worth Anavex contacting the NFL or one of the other researchers about investigating the possible efficacy of 2-73 in TBI/CTE.

If Anavex hasn't considered this, I would gladly send IR this post.

http://www.cnn.com/2016/09/14/health/nfl-concussion-safety-initiative/

Congratulation fellow board members, you are both positive and constructive and in my estimation an extremely valuable adjunct "Board" to Anavex's BOD. Your insightful knowledge and dogged research is very encouraging to your peers and I have to believe. to those at Anavex who keep their finger on the pulse of we who invest in the company. Thanks for your advocacy to those in the medical profession, the disease focused associations/groups and our federal government representatives and agencies. We have thrown out the life buoy, we just have to continue to shout and point to the "man overboard" where to swim to!

My prayers are for those who suffer. May God grant us success for them.

One more thing...thank you for treating each other with respect even when there are differences of opinion or interpretation.

May you all have a prosperous and healthy 2017

Hessmessinc,

Outstanding compilation of success factors which will move Anavex forward in the New Year to provide solutions to so many sources of human suffering. I humbly submit one other on behalf of my fellow vets:

16. Veterans Administration champions research and secures "Cures Act" money for the use of 2-73 and
3-71 in treatment of vets with neurological damage from Alzheimers, Parkinson's, TBI and PTSD.

Reyeton, Great reference article. It indicates the level of commitment of the VA to Alzheimers research and the importance of Anavex to that effort. Couple of observations:

- The older veterans are being treated and tracked within the VA heath system and are candidates for Alzheimers' drug trials (see link to "Experimental drug pack double whammy against Alzheimers")

- There is corollary research to Anavex 2-73 in progress within VA research arms (see link to "Chaperone proteins may hold promise for Alzheimers treatment")

- Va research has identified the fact that dementia medicines (cholinesterase inhibitors such as donepezil may contribute to clinically significant weight loss which could be a critical side effect in older patients)

- TBI (Traumatic Brain Injury) has been shown to be linked to a high incidence of dementia in older vets and is a cause for concern for younger vets returning from Iraq and Afghanistan. See the quote from E. Teresa Touey about Dr Messling's participation in "Mental Health Parity and Addiction Equity Act Roundtable". Many vets' health care lies outside the VA system in private, group or Medicare/Tricare coverage as does mine as a retired military member.

- As I posted before, one of our new SAC members, Dr. Daniel Weintraub serves within the VA at the Philadelphia Veterans Affair Medical Center and should be the conduit for the company to VA related research.

Besides 2-73 P3 and the Rett Syndrome Orphan Drug study, the key may be in the three new members of the Scientific Advisory Board

- Dr,Tanya Simuni: "She has built a multidisciplinary Parkinson disease center that has been designated a Center of Excellence by the National Parkinson Foundation...As principal or co-investigator on numerous NINDS, MJFF and industry sponsored clinical trials, Dr. Simuni has done extensive research on the treatment of Parkinson's focused on studying potent potential disease modifying strategies."

-Dr Daniel Weintraub: "A geriatric psychiatrist, he conducts clinical research in the psychiatric and cognitive complications of Parkinson's disease at the Parkinson's Disease Research, Education and Clinical Center at the Philadelphia Veteran Affairs Medical Center...and is current Clinical Core Leader of the Penn Udall Center focused on cognition in Parkinson's disease."

- Kalpana Merchant, PhD: ""has deep expertise in the neurobiology of chronic neurodegenerative and psychiatric disorders....25 years of experience in drug discovery and development with a special emphasis on transitional strategies that improve the success rate of drug development. She retired in March 2014 from Eli Lily and Company where she was the Chief Scientific Officer for Tailored Therapeutics ... accountable for scientific and business strategies for the neuroscience portfolio"

There you are "ladies and Gentlemen"...the experience, credentials and connections to launch the 2017 Anavex 2-73 Parkinson's trial.

Additionally, Dr Missling, earlier this month got Anavex's foot in the door at the Annual Mental Health Parity Addiction Equity Act Roundtable on the issue of "brain injury repair" such as Traumatic Brain Injury and Post Traumatic Stress Disorder both key to the New Administration's priority for better veterans care.

What a line up we have for human care and to reduce suffering!!

Two points:

First, for those looking for word from the FDA...you are not going to hear much from any Federal Agency in the last two weeks of the year. And with the change over of Administrations and the new head of the FDA bringing in his key people, operations will be slow for the first quarter of 2017.

Secondly, is there anyone on the Board from Wisconsin? With Speaker Ryan's priority to keep the budget in check, driving down the costs in Medicare/Medicaid is one of his top priorities. That will be impossible with the tremendous current and rising future costs of Alzheimers and other CNS diseases.
The Board would do a great service to ourselves and the country by getting the Anavex story to Ryan's House staff and the Ways and Means Committee as well. Thoughts/ideas anyone?

You can see the lights on long thru the night in the CNS Divisions of dozen or so BP's. The stakes are immense after CTAD 2016. The Rubicon has been crossed and the CEO's and Corporate Boards are demanding answers. Can we or should we continue to comit additional millions on our own Alzheimers drugs when this little biotech, Anavex is showing significantly better results. Added to that, Anavex 2-73
seems to have application in a wider range of CNS disorders. They want technical, financial input and answers from their industry intelligence sources about the contemplated actions of their competitors. If someone blinks, heads will role and those BP's who miscalculate will lose future $Billions in one of the most lucrative and rewarding areas in the pharmaceutical world.

The tension is so thick it can be cut with a knife.....a little like the hours before the start of Desert Storm!

Sent the following to "Stansberry Digest" which advertises that it has 1 million investment subscribers and which on 10 Dec headlined on that days edition, "The first Alzheimers Drug that has ever worked" heralding Biogen's purported success with "aducanumab". Attached "falconer66a"'s excellent synopsis.

Read with interest your recommendation of Biogen based on their Alzheimers drug candidate's initial success in Phase 1 testing. Both Lily and Biogen's trial efforts have been proceeding on the premise that Abeta plaque is the main target in treating the disease. As stated in the article, there have been many failures based on drugs targeting Abeta and Tau; Lily's withdrawal of "solanezumab" from FDA trials after $millions spent being the most recent example. Biogen's "aducanumab" may be giving better results but what was not mentioned is the problem of Amyloid related imaging abnormalities (Aria) which can cause serious swelling in the brain in certain Alzhemiers patients. Biogen and Anavex Life Science ( a smaller biotech) both reported trial results at the CTAD Conference in San Diego on Dec 10th with Avavex reporting better results with no significant safety issues. You might want to do some due diligence on Anavex whose share price is under $5 as opposed to Biogen's near $300. Here is a biologist's short synopsis from Ihub's MB of the company for your review.