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Sure thing pgr... It's posted on @adamfeuerstein Twitter page 5 days ago.
There needs to be triple-leveraged ultra short ETF consisting of all the companies issuing press releases about investigations into "naked shorts" and "spoofing."
— Adam Feuerstein ✡️ (@adamfeuerstein) February 1, 2023
Ticker: SHTCO
Has there ever been a bigger a-hole roaming loose without a muzzle on planet earth? I think not.
@adamfeuerstein
"There needs to be triple-leveraged ultra short ETF consisting of all the companies issuing press releases about investigations into "naked shorts" and "spoofing." Ticker: SHTCO
Totally agree. For crying out loud... Cut the Zoom call crap and meet with your "great unwashed" shareholders. They usually don't storm the podium unless you give them a reason to do so.
Good post. I agree the most likely motivation for AVXL shorts, with all the countervailing evidence of possible success, is they're convinced there's a major stumble likely in the near future. That would be a wet dream come true for them. I also suspect there's a thrill seeking motivation for some shorts who love the idea of demonstrating skill in snatching nickels four inches in front of the steam roller.
In any event, they're very good at what they do which is why a legitimate, bolt out of the blue, short squeeze is a very rare and unlikely occurrence.
FB post on the new IR hire by monregi on ST... I think it was posted on IH earlier today.
$AVXL From FB group: Anavex continues to attract top talent to the team. Luke Brown, who bills himself as a Capital Markets and IR Professional, has recently joined Anavex as a Sr. Director. His bio prior to Anavex:
Luke Brown leads the NYSE’s capital markets efforts in the life sciences space and is charged with building a biotech franchise. He was previously a member of the team at Solebury Trout where he worked in IR for two years, working with both public and private healthcare and biotech companies. Prior to that, he spent a decade at NASDAQ in a research capacity. Early in his career, he was an accountant with the Bank of New York.
And from his LinkedIn bio:
From the start of my career, I have consulted with executives and contributed to successfully meeting their goals, regardless of size and scope . From enhancing investor relation programs to bringing companies public, I've worked with the entire ecosystem of advisors, lawyers, bankers, trade groups and investors
"The multi-center, double-blind clinical EXCELLENCE study (ANAVEX®2-73-RS-003)[4] in pediatric patients is measuring safety, tolerability, and efficacy of daily oral ANAVEX®2-73 doses or placebo. After completing the double-blind study, eligible participants are able to join a voluntary open-label extension study of ANAVEX®2-73. In communication with the FDA, we received their input on the endpoints, which were utilized in this study."
Praise for the participating parents, many who know their child may randomly be placed in the placebo arm. Glad they have the promise of an opportunity to join the open label extension study. If ever a patient group and their parents needed hope and medical help...
Video posted by pietrzkiewicz on ST.
"Then you get a chance to help bring a drug to market that can make a real difference in a company that needs your expertise desperately. It’s a place where your impact will be felt and your work valued with a lasting impact for generations."
JJ - I like all your points.
I also suspect with the clarification boi568 provided on Mr Kin's government service tenure he was eligible for retirement and saw the Anavex opportunity as a chance stay active and engaged in important work.
Good catch on Kun Jin FDA tenure. I couldn't locate any references earlier than 2009. Needless to say he has some valuable knowledge and connections.
Modest research into Kun Jin participation as a conference speaker or panelist during his FDA tenure reveals his direct association with representatives from Merck, Novartis, GlaxoSmithKline, AstraZeneca, Eli Lilly, Johnson and Johnson, Amgen, Janssen Research, Sanofi, Bristol-Myers-Squibb, Biogen, to name a few. He role as a lead FDA trial statistician likely built familiarity and intimate working knowledge of drug product submissions from a host of pharma companies across the board.
Notable he walked away from a lucrative government pension after 14 years at the FDA. His hiring by a small biotech no doubt sent shock waves through the pharma industry.
His insights will be highly valuable when weighing potential partnerships.
The original Forest Pharma drug application for Namenda in 2009 is linked below. The application was approved in 2010 and has been a primary part of the SOC for the treatment of AD for 13 years. While enjoying SOC status, Namenda patient benefits are marginal and relatively short lived. Kun Jin was part of the review team and his sign off is reflected at the end of the application. His intimate knowledge of Namenda and the comparative treatment advances and advantages of 2-73 should be invaluable in discussions with his former peers at the FDA. Looking more and more like an extraordinary hire.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000StatR.pdf
Posted on Yahoo board. Likely one of many dissenting opinions to come from Physicians pushing back on Lecanemab.
https://news.yahoo.com/brain-bleeds-nope-too-soon-004340926.html
Saw this reference to an Asian study published on the NIH site designed to assess the rate of decline in AD patients who received a placebo in various trials.
"Placebo-controlled randomized AD clinical trials were systemically searched in public databases. Longitudinal placebo response (mean change from baseline in the cognitive subscale of the Alzheimer's Disease Assessment Scale [ADAS-cog]) and the corresponding demographic information were extracted to establish a disease progression model. Covariate screening and subgroup analyses were performed to identify potential factors affecting the disease progression rate.
Results: A total of 134 publications (140 trials) were included in this model-based meta-analysis. The typical disease progression rate was 5.82 points per year. The baseline ADAS-cog score was included in the final model using an inverse U-type function. Age was found to be negatively correlated with disease progression rate. After correcting the baseline ADAS-cog score and the age effect, no significant difference in the disease progression rate was found between trials. However, a significant difference was found among different trial regions. Trials in East Asian countries showed the slowest decline rate and the largest placebo effect."
Broad application of 2-73 to dramatically slow and control the rate of decline in the general AD population?
Schwab dropped me a notice today saying I had shares that were in high demand and would I agree to loan them. Wasn't AVXL, but GNS. In any event I wouldn't ever loan anything I hold to help shorts cover. The quoted loan interests rate of 227% was so insane I called Schwab to confirm. I assume that reflects the level of desperation GNS shorts are feeling? Others on the board may have a better read on the crazy loan rate than I do.
Fun to watch GNS go to war but AVXL, who we suspect is also being victimized, has other more pressing things to accomplish.
Public Service Announcement based on feedback from other IH posters.
Anything reposted or shared from another board is for information purposes only. Everyone should make their own assessment about the veracity of the post and the poster. Reposts are never a suggestion or endorsement for action of any kind.
I appreciate the responses and input. Thanks,
G.B.
In a subsequent post bigBio gave this additional account of his conversation with IR.
"I asked Clint. . How about Roche .. he said everyone is looking at Anavex!! There is no way to say who gets the deal.. Best deal wins."
My view - While no pharma is naturally revealing their intentions, it's logical to assume they all see 2-73 and the other formulations in the AVXL portfolio as potential decades long SOC blockbusters for multiple known indications and perhaps others yet to be identified. FOMO is a powerful motivator when you have the means and the will to win at any costs. A partnership is a certainty, a costly effort to own the science outright is not out of the question.
FWIW... Just posted by Big Bio on ST.
$AVXL Talked with Clint from Anavex...
"New hire.. . He said kun jin (Anavex new hire from FDA)came from the Aduhelm and Lecanemab trials with the FDA. Kun was the lead statistician at the FDA with both of those drugs. Clint said he is an awesome new hire. Also clint said every time Blarcamesine data comes back it looks better and better. . He said he would expect Anavex to file for Accelerated Approval during this year. . I said Lilly just took 100 patients. He said Anavex could do that also and all of that makes Anavex pleased how easy the FDA wants to make Accelerated approval here. He laughed ?? about SAVA and said yeah they are 3 or 4 years behind Anavex... Sava is not a competitor to Anavex. Partnership is something that is certainly on the agenda."
Like NWBO, GNS serving notice they are declaring war and pursuing legal action helped as well. Nice to see some CEO's fighting back.
Naked shorting has been accepted as business as usual so long by the SEC the criminals steal and destroy without any fear of repercussions.
Good to see the increase in positive press. While we're all anticipating an initial partnership, it's fair to look further ahead and assume Anavex will ultimately form multiple partnerships with pharma companies who see the benefits of adding Blarcamesine to enhance the upstream cellular environment to improve the effectiveness of their drug. Yet to be confirmed, but we likely have a universal ingredient that safely works with other compounds. Extraordinary potential.
Piggy backing on baspark79 post here's the supporting Wes Christian - Roger Hamilton video interview link on naked shorting. As mentioned CEO Roger Hamilton was on Charles Payne, Making Money today.
Every start up company waits for the singular event, announcement or development that changes and solidifies their fortunes. Going from a speculative enterprise to a going concern. We're very close.
If you can listen to todays presentation as someone hearing the information for the first time, it's hard not to be impressed with the medical and financial prospects of the company.
The AH painting is comical. Shorts are playing with fire. There were people at JPM with deep pockets who can change the glide path of the stock price quickly if they choose to do so.
TGD moved the needle sufficiently for me to comfortably add more shares. I'm confidant BP is paying attention and a data loaded peer review is likely not that far off. "Disease modifying" is publicly stated and on the record as is the stark performance and safety differences with lecanemab, whose market life span will be short.
"This greatly reduces the chances of a friendly deal, but leaves open a "bear hug" stock tender offer. The lower the share price, the cheaper any tender offer would have to be."
Unlikely to become public, but an all out, to the death, BP bidding war would be highly entertaining. I'd gladly buy the popcorn.
Short interests continue to bet against the company's success. It must be really hard to get off a gravy train you've been riding for years. In fact you don't get off, you have to be knocked off. Shorts will go down fighting.
Short interests continue to bet against the company's success. It must be really hard to get off a gravy train you've been riding for years. In fact you don't get off, you have to be knocked off. Shorts will go down fighting.
It's always possible they won't expand on and clarify their December 1st TLR data release but I'm not sure how they plan to fill a 40 minute time slot if they're not going to address the elephant in the room.
They've had over a month to prepare and it's a very big stage to simply rehash your pipeline slides and indicate you plan to talk to regulators at some point.
Clarification and validation of positive 2-73 AD data Thursday will help the stock price. So will a signal the FDA isn't going to demand a formal and unnecessary phase 3 trial that materially delays 2-73 market access.
J.P. Morgan Healthcare Conference starts tomorrow. Minimal conference info is in the link. Note keynote speakers. See FAQ - Attendance is by invitation, agenda is not shared outside of attendees, which number in the thousands, and press access is limited.
https://www.jpmorgan.com/solutions/cib/insights/health-care-conference
Worth a quick refresher on 2-73 2a AD trial results that provided the basis for 2b/3 efforts. Sadly if BiiB, Lilly or others had delivered these results after a phase 2 trial they would have immediately pushed for AA or Compassionate use. You would also logically assume the FDA was aware of 2-73 as early as 2016 or earlier. Seriously, it's now seven years after the 2a results were published. Do the math on the human suffering. Pardon my French, but WTF!!
NEW YORK, NY – December 8, 2016 CTAD Conference
"Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today announced a positive 57-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. The study met both primary and secondary endpoints.
At 57 weeks, Alzheimer’s patients taking a daily oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events.
Published AD studies confirmed substantial declines of cognitive (MMSE) and functional (ADCS-ADL) measures as well as Cogstate and EEG/ERP over 12 month in similar AD populations. Pre-specified exploratory analyses of the current study included the cognitive (MMSE) and the functional (ADCS-ADL) as well as Cogstate, HAM-D and EEG/ERP changes from baseline.
Specifically, in comparison to historical control from a pooled placebo arm cohort study conducted by the Alzheimer Disease Cooperative Study Group in mild-to-moderate AD patients of comparable ages and MMSE baselines, over 12 month the ANAVEX 2-73 data shows a calculated treatment benefit of 1.8 points on the MMSE scale (p<0.016) and a calculated treatment benefit of 4 points on the ADCS-ADL score (p<0.019). Furthermore, the correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, commented, “In addition to the very encouraging results, which point to the therapeutic potential of targeting cellular homeostasis in a complex CNS disease like Alzheimer’s, this trial has been intelligently designed as a highly informative study, looking unprejudiced at all potential relationships and hence allowing to learn from all correlations of the now available pool of data, in order to execute subsequent trials with much more relevant information at hand.”
"Missling is now in a position to contrast the data from the AD trial with the published data on the Lecanemab approval."
Agree...timely while the BiiB drug negatives are fresh in the medical communities minds. Anavex will have a big stage Thursday, let's hope they use it effectively.
You have to wonder with all the AE concerns, why the FDA didn't demand a post marketing phase 4 trial for Lecanemab. It would have been an easy requirement to impose.
The FDA just lowered any barriers for 2-73 approval.
Published today in the Free Press. Comprehensive summation of the singular years long Amyloid tangle obsession and abject failure. This author has no inkling of the effective 2-73 alternative whose emergence on the health care stage could not be better timed. Let's all trust next Thursday begins to change the world view there are no safe and effective ALZ treatment options.
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
Link published yesterday by an investigative writer on Substack. Chronicles a list of egregious wrong doing by Pfizer. I was curious how the self proclaimed Night King of the biotech world, Adam Feuerstein, could have overlooked such a target rich collection of wrong doing in his backyard. There's enough material here to keep AF busy for years. As I searched for various references to titanic battles between biotech/Pharma crusader AF and evil Pfizer, I couldn't locate a peep from AF linking him to challenges or condemnation of Pfizer criminal practices. I'm guessing every single one of us on this board can conjure the reasons why. AF picks his battles carefully, he has "friends" at Pfizer and/or he's simply a journalistic coward.
https://threadreaderapp.com/thread/1610375042940153856.html
I'm less and less worried that a couple of our preliminary CTAD slide points didn't exactly tic and tie. Looking forward to January 12.
The question that bears repeating...
Why isn't Biogen serving a 15 year sentence in drug approval purgatory after the stunt they pulled with Aduhelm, which also took the FDA's shaky reputation down with them.
"The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.
The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."
https://www.nytimes.com/2022/12/29/health/alz...be517a9e6e
But they're already back with another flawed offering soliciting FDA accelerated approval Friday of this week.
For the BiiB CEO, his C-Level Suite circle and the BiiB Board - "Ethics" A system of moral principles or rules that say what is and is not acceptable. A code of conduct honoring the rules of society, laws and religious teachings. In essence, knowing right from wrong. This bunch obviously slept through Philosophy classes and Sunday School.
After having been burned by past Biogen predatory pricing and questionable trial practices one might assume the FDA would tread very carefully on the upcoming January 6th AA BiiB decision.
We're quickly reaching a point where it's difficult to name one US Federal agency that isn't ethically compromised.
Published today in Forbes. I wasn't blocked by a paywall. If blocked, hopefully someone has access to a link that's open.
Article is a bit lengthy, but reinforces some of the hurdles BiiB faces as they try to jam Lecanemab through the approval process. Forbes indicated Lecanemab price could be a significant issue especially with Federal Gov't health agencies who administer Medicare and Medicaid. The article also indicated doctors may simply determine the risks are not worth the modest improvement Lecanemab is likely to deliver to their patients. I though the risks for brain bleeding and swelling were lower than the 21% referenced in the article. While the ALZ Association has thrown their full support behind Lecanemab, the high incidence of adverse effects could impact any FDA inclination to grant a snap approval. We're about to find out.
"About 21% of patients treated with lecanemab experienced brain swelling or brain bleeding that was visible on PET scans. Also, scientists have tied a third clinical trial death to lecanemab."
I feel great about the better alternative Anavex has to offer.
https://www.forbes.com/sites/joshuacohen/2023/01/02/with-fda-accelerated-approval-of-alzheimers-drug-lecanemab-likely-january-6th-discussion-turns-to-price-and-reimbursement/
"More than any other time in history, mankind faces a crossroads. One path leads to despair and utter hopelessness. The other, to total extinction. Let us pray we have the wisdom to choose correctly." -- Woody Allen
The FDA is is looking at a similar choice. An impending decision to conditionally approve toxic BiiB Lecanemab with conditional warning labels and/or Lilly Donanemab, which clears sticky Amyloid plaque like crazy and is pushing for approval in early 2023 based on rolling phase II trial data. Both drugs have been awarded FDA Breakthrough Drug Designations and Fast Track approval paths. Apparently the FDA now has a vending machine in their lobby that dispenses Breakthrough Therapy and Fast Track Certificates.
Fortunately a timely white knight AD treatment choice has emerged. A treatment (2-73) that can potentially save the FDA from themselves with none of the nasty brain bleed side effects, touting effectiveness higher than BiiB and Lilly in an easy to administer pill form. The FDA has thus far only bequeathed Anavex with Orphan Drug designations for 2-73 on a couple of non-AD health conditions.
Let us pray the FDA will weigh all their choices fairly and have the wisdom to choose correctly.
This great William F Buckley quote was made for you George...
"I ask myself the other day, who else on so many issues, has been so right so much of the time?" "I couldn't think of anyone."
Happy New Year buddy.