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The Adu Post
Why this happened;
Dogma (never have used the word cabal). Dogma is simply one track thinking which is relentless and obsessive in nature which when coupled with power (people who control committees, boards, publications, teaching) pins itself to certain ideas and fosters nothing but those in an irrational fashion. It is insidious, intolerant/dismissive of new approaches, and continues to teach and indoctrinate successive generations (like the monkey banana experiment) until no new thoughts are developed/conceived/permitted to be brought forward. This is dogma and when it enters an environment it is like a parasite which envelops a host - no cell left unoccupied and nothing new can grow as long as dogma stands (political scientific investment/business whichever arena). Dogma never dies, it must be killed.
The notion that the FDA is corrupt and would be bought/paid off in order to approve this drug is the group of moves which in chess are referred to as The Scholar’s Mate: 4 move checkmate. This (Adu approval) was no Scholar’s Mate. Here’s the compelling reasoning why that’s not a logical explanation: since when has any BP NOT possessed the resources necessary to buy the FDA? They could have coughed up 200k$ going as far back as the first amyloid plaque mab if that were the necessity.
Ask yourself why the FDA could approve a completely failed drug in such a blatant open reprehensible way now, today, as opposed to former days in the life of the amyloid theory when the prevailing winds were more favorable?
In order to kill dogma there must be a successor which is not part of the dogma. In the dynasties, it’s “meet the new boss, same as the old boss” (credit, The Who). Kim Jong Un…not unlike all the “Kim’s” before him. Nor will the next one be. Much like the Caesars - it’s simply a new name to learn but the dogma remains (Just Around The Corner Came Nero: Julius/Augustus/Tiberius/Caligula/Claudius/Nero - your mnemonic for the day).
If the FDA approved the dogma prior to Adu, or not, every drug which came after would have to have been a plaque mab. The end of civilized medicine for Alz as we know it.
Why could they take the bribe money this time? When they could never quite bring themselves to take it before??? Scruples? No. Valid evidence? F No!
Because they now have an heir apparent waiting in the wings which represents a new regime? Hell Yeah!
And now dogma must die. But how do you kill it?
Expose it. Exposure kills dogma like light drives away cockroaches. Someone has to expose it and show people that it is a failed theory so that it can be seen for the repulsive instrument it has been all these many years.
In broad daylight, run it up the flagpole where it will be saluted or refuted. Look at the renowned credentialed professionals coming from all directions to refute this. It’s over. The theory is only spoken of as non-efficacious, serious side effects, expensive and unconscionable.
Exposure. It’s why Mamie Till left the casket open. People would forever say that racial bias was “just a fantasy” and “a bogeyman” and “all in your head” if they never saw it with their own eyes. The body of a disfigured youth, not even recognizable, deprived of life, had to be seen to be believed. It was.
Saddam Hussein, had to be seen dead. Mussolini was dragged through the streets. Announcers had to intone, Elvis has just left the building. Some people thought Elvis, Michael Jackson, Princess Diana, were still alive in hiding somewhere. The human mind needs a free body or a trial to detain/imprison that body if grounds are found (habeas corpus let us have the body - until proven guilty - the cornerstone of our legal system down from Rome - Latin phrase). Tell a person there are billions of stars in the sky and they’ll believe you. Tell him a bench has just been painted and he has to touch it to make sure.
The concept of amyloid plaque was intangible, as the stars in the sky. The trials are real, as the bench. Folks must see this theory die tangibly before they will accept the death knell.
Once the dogma has been cleared, it opens the chess board for other players and pawns (theories) to advance and attack the REAL target. The target has never been Biogen, BP, FDA, or Amyloid theory. The enemy has always been Alzheimer’s - that’s the king, overshadowed by the queen (incorrect amyloid theory causal connection) all these years.
The FDA did what Bobby Fischer did when he was 13 years old and playing a grand master in the match of the century. He made the sacrifice of the century: sacrifice queen. Not exchange queens, or trade for a lower piece, he gave up his queen. Why? To checkmate the king.
FDA finally saw that it had to play the hand up/open and show this theory to the world. If it took graft and complete rule breaking to “approve it”, and that is known, and more media expose how poor a choice this was / worst in recent history…etc, and if the drug is monitored closely and can be revoked, other theories can come to light.
Anavex filled that void instantly after approval was condemned and sank in. Our MOA has now stepped up. There’s an order to how the pieces must fall. We are employing the correct order to effect a strategic outcome - dictator regimes don’t just tumble themselves, you know.
The transition must be swift and permanent.
Pawns to the wall: Rett and PDD equals 2 queens and new regime ushered in along with the peer reviewed article.
If Adu had not been approved (to fail) it could never have set up for an Anavex move forward on the board. Gained real estate and very soon material (pieces i.e., $$) Along with control of the strategic center squares and tempo; recipe for the win. If Adu had not been approved, more plaque drugs would have kept advancing. It’s done. It will toll its own bell.
Interesting things to think about:
Dr Missling said we have had interest from other companies but he wants to maximize shareholder profit.
In chess and business, the plays which end the game and determine the winner/outcome are:
When you sense you may be in danger of losing but not sure, you offer the opponent a draw. If he/she accepts the draw, they weren’t confident of the outcome either - draw. Fair.
If he/she does NOT accept the draw, she is confident of the outcome (which you both should see) and you resign. That’s the honorable play. The exception is in the case of a young prodigy who has played brilliantly and is close to mate - you do not offer a draw, instead, you play to mate and allow them the full victory, not a resignation. That’s chess protocol - show posterity the progress of play down to the victorious Mate.
If Missling is not quite sure how our human trials will turn out, he must shake hands and accept that draw (offers which he has mentioned). If no offers are made, he must resign. Since he did neither he is confident that he sees a clear path to mate.
That’s good enough for me, though I intend to watch. This is the dawning of a new age. ( Cue: Theme from 2001 A Space Odyssey)
Elvis left the building on June 7, 2021.
The sigma 1 receptor MOA which is used by Anavex states, among other things, that as we age expression of the S1r is decreased. And more so in AD patients. Although it is not necessary for approval, I would feel more comfortable if our MOA could account for the gender difference in the disease. That would tie this up with a neat little bow and in fact it should be accounted for in there somewhere to make the case not simply compelling (folks respond so that’s the aim) but airtight.
Let’s see what the age factor looks like:
US female population is slightly larger than male to begin with (more girl babies born than boys - Dado is an outlier - all boys, 3 - as am I 2-1).
The Vietnam war killed 53,000 young male US military soldiers in combat, 17,873 non-combat, and 159,000 wounded according to US VA statistics. Additionally, it is postulated that later war casualties from various non-combat related issues, as well as PTSD and suicides, substance abuse casualties could have put that number closer to 2 M veterans dying from war related causes.
That was an event 55-60 years ago which decimated (literally reduce by one-tenth) the male population which would be facing AD due to age related loss of S1r decrease about a decade ago and continuing.
We only need to add the average life expectancy for females slightly higher than males (now that childbirth is no longer a young female population thinner and war still claims young males), as well as the Progesterone Theory (copyright Biostockclub) to account for the AD female chauvinism. The MOA was compelling and my theory provides further evidence of it being related to the cause. That’s why I brought that piece into play early in the game - still standing and defending. If it helps the cause at the end - just recall I planned that move in 2018. We will get this!
Additionally, BIIB has 9 years to prove efficacy/clear safety over and above everything else. Our IP patent on AD expires 2030 (I believe) which is 2021 plus 9. Hm. If we are stalled and forced to perform another big trial or 2 big ones…IP expires…Biogen et al can use our formula for AD - how about that Morphy Defense as a reply? But, with Rett and PD pawns almost to the wall and other interested BP’s we will not let this slide, chance of that happening: very slim.
The reason this happened is because
one can’t prove a negative. If Amyloid theory is never tried it can NEVER fail…trade off - must fail the negative first (amyloid/Aduhelm) in order to open up the board for new theories which will be effective.
Today: further confirmation - Public Citizen calling for FDA heads to step down or be removed.
In either case of the Adu decision, Anavex had the FDA pinned (chess, immobilize a player pinning it between king and threat of check) with threat of TGA P4 approval. Had to move a “pawn” in between to unpin the threat of check. I believe the offering up of the amyloid theory by approving in order to kill it was the sacrifice FDA made in order to have Anavex approved for Rett in US followed by accelerated approval for AD - since that “trade route” has been pioneered by the soon-to-be-revoked Aduhelm. I hasten to add: with very different press coverage surrounding this one and Ad Comm unanimous support. Throw in the advocacy groups and you’ve got a winner out of this gambit - worth all the preceding moves.
If denied accelerated approval, we have Australia ready and waiting with the SAS provision to demonstrate the side by side (Pepsi challenge) between Adu and Blarc. The walking dead vs the Waking dead - no contest. I discussed this clear and apparent showdown in a post prior to the Adu approval. Lot of moves on the board. We still control the center and have plenty of real estate and material guarded (patents) to see the opponent concede…it’s THAT obvious.
Don’t let me ever tell you there’s no chess game going on. Each decision every day of your life involves some form of strategy (think: crossing the street, random walk or timed maneuver? Anyone over age 9, unaccompanied, who doesn’t employ the “right moves” will not go long.)
I know of some fairly quick studies who still fall for the Scholar’s Mate e-v-e-r-y d-a-y o-f t-h-e w-e-e-k - that’s WEAK.
At least learn to Think about bigger vision than tunnel vision if you are looking to get wealthy, healthy, live well and long. The 4 move trap belongs to lower echelon evolutionary species. Not mammalian brain - can’t see beyond “broad generalizations” e.g. “horoscopes are for housewives”. Taunis, I’m a Leo and my horoscope every single day says: This is your f’in day! I stand with you in not tolerating gender discrimination. (Most men feel the same, imo.)
Use your cerebral brain to ask more questions: why would the FDA halt trading at 10am (bicoastal attention) to announce the most blatant ass-chap decision in my lifetime when they could have done it after hours? Why? Seems kind of next level attention grabbing shit, no? If it’s a scandal, it’s usually done in the dark. Not a scandal/corruption/broken system. The fix was in - this WAS the FIX for the broken system. The only way to fix it. Don’t stand under a heavy branch which is half broken / far less dangerous to saw it off. Saw it off! Now, it poses least danger and a new one will grow.
So, they disagreed with and lied to an advisory committee. They disregarded statistical measures of clinical benefit (set by them), shifted endpoints after assuring they would not, acknowledged serious side effects but weighed the (non) benefit and found it ok if kept under further monitor, and now face backlash about resignations, payoffs/contributions/bad press - get that exposure!/ calls for more heads to roll, in broad daylight, market hours, all eyes focused… recall when the discussion was about black swan events? This is a magnificent black swan - it is never seen. There is a reason. White swan (queen, well Knight(!) making an appearance soon)
There was a reason I saw the SAS move in September as well as the 1.5B$ MC by June.
It pays to think ahead - never be afraid to do that - it is not a daydream or fantasy (if so, why are my daydreams coming true? And I’m about to step up my fantasies…)
Dr. Missling is a dreamer who can execute the dreams of checkmate by making the rational, clever moves he has been making, at the correct time and backed by legitimate science. I’ll wager my AVXL balance that he would not be taken in by the Fool’s Mate. Neither did any of you wayyy back when we were at 1.95/sh and I quoted W. Churchill that This was our finest hour. For those who held…it was. Thanks to that endurance, we have today. And shout out to Bennyboy wherever he is. (Personal note: I prayed for him at a grotto yesterday and a butterfly landed on my shoulder. Take that for what it’s worth.)
This was no Scholar’s Mate - this was Ruy Lopez open, Morphy defense reply, Marshall Attack…wayward queen response…she’s a rogue of mayhem (past 30 years…the devastation in CNS…lost real estate/material (captured pieces)/ but the kiddie-counter defense works on wayward queen and she is eventually captured.
You have all heard the expression not to pay for the same ground twice when doing work. Don’t move things which will have to be moved again - just move it once to the final destination. The FDA has had no other choice but to pay for the same ground over snd over for 30 years (plaque attack). Again, there is now a new sheriff in town. Cool. We now move to new ground / at long last/ pay once…Higher ground.
We got this.
My views respectfully submitted,
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