Nidan,
I’d like to address your question: What does AVXL have to do to get its foot in the door...
...of a seeming lock hold on the industry perpetrated by WS and FDA/ government / network. The discussion applies to the environment in which our company operates and I hope it is not deemed off topic, but, here goes. (Since it’s a slow day on the mb)
First, let me start by saying that while what you say is true about the appearance that WS/BP/FDA are a powerful, insulated triangle, trying to protect the “good thing they got going”, I also agree wholeheartedly with frrol’s reply:
“They're not crooks and we are not victims. There is a great need for effective AD treatments and a tremendous amount of resources, risk, and uncertainty in trying to find and develop them. It's not a conspiracy. Biogen's drug is not proving very effective and hopefully ours will prove better.”
He’s right, imo. And, human nature being what it is, you are also correct.
Here’s the juncture where these two reconcile - and, more importantly, what’s being done about it - by ANAVEX. I can’t speak for other biotechs.
First, the word “corrupt” is based off a Latin root rumpo, rumpere, rupi, ruptum (principle parts of verb “to burst forth, to break”. Old Latin majors never die, they just lose their principle parts. Joke! Classics humor.)
So, originally, the concept of “corrupt” means broken, and words like rupture, erupt, interrupt...are connected. Just breaking forth, breaking into a conversation, a break or rupture in something. The Catholic Church notes the bodies of saints are incorrupt - no decay, physically.
But, corrupt takes on a “morally decayed” meaning and has that connotation.
I believe that you (nidan) are suggesting that the system: WS protects its investments in BP and the FDA is intertwined because of the political economic environment indwelling which needs a prosperous economy, sometimes more than it needs a healthy-bodied electorate body, enables the opportunity for politics to affect the FDA to affect BP and the pharmaceutical industry including biotech start ups, which affects WS. That all exists. The opportunity is there. Proof can be found in the fact that in the past 4 years we have had 3 FDA chairs, during a pandemic and a healthcare crisis for our elderly and Veterans, and it appears as though the system is one of playing musical chairs and popularity ratings than actual stewardship of people’s health on any level.
But, frrol is correct that honest efforts have been made, I believe, to adhere to the system’s intention of bringing safe, efficacious drugs to market even within this polarity of conflicting interests. Nothing works perfectly, good intentions don’t always pay off, and nothing outside of the theoretical world operates in a vacuum.
Even Xena’s contention that a vast number of drugs make us worse has merit in a system which is broken.
To answer your question, what can be done about this? First, back to acknowledging frrol’s post - assuming that the system is broken and has its flaws, I take him to mean that on the face of it, no one is out to personally target Anavex for never getting to market. If there is a problem, he might well acknowledge that the system is not perfect, but we should acknowledge that it’s not personal. The same inequities affect every small biotech which is trying to prove a new drug or theory, pre-revenue, with good/great intentions. We are not special targets. I agree. But it is within human nature to protect your territory.
Aside/
I jog 7 mi each day. Same path through adjacent neighborhoods with some hills for cardio, (Allegheny foothills - we are not flatlanders in western PA) strong leg and back workout, and some flat stretches to catch your breath - all good.
I noticed early August that there was the start of a very tiny corn stalk growing in one of the yards I run past very close to the street. I watched it every day - so miniature, was just a volunteer stalk of corn. Sure, I was tempted to pick it, but...nah, just kidding.
So, yesterday, I saw a man at the house who had just entered and closed the front door. I passed the yard and there, next to the tiny, single, corn stalk, he had staked a small, the smallest scarecrow I have ever seen! Lol - great sense of wit and pride!! This was his corn! His “big eating” - eventually. He was going to protect it at all costs...or at least show the world he had something worth protecting - even in a humorous way, it still is human nature to protect our turf.
And, on a much larger scale, that’s what BP’s must try to do. And other businesses as well.
I think Dr. Missling is far from banging his head against a wall. He surely knows the territory having been in the healthcare sector of hedge funds and worked at other BP’s and he’s seen the world. He was not born and raised in the US. He knows what kinds of cultures there are on this planet in various countries.
Aside/ I used to frequent a family run Indian restaurant in college and the health board would come in and collect payoffs to keep from shutting them down. And they always seemed so forlorn asking for more time or for them to pay less. I was young and naive and talked with the owners and said that’s not right that you have to pay just because you are foreigners and they know they can get away with it. I was outraged and disappointed - but the response was enlightening. They laughed. They said, “it’s NOTHING. In our country, we have to pay at least twice as much!”
But, the health board knew, and the owners knew, and they were both in a better situation. Apparently, only I didn’t know. That’s how you learn how the world works.
Missling knows how the system is set up (I don’t want to say how the game is played. It’s not a game. And it does no more good to say The Emperor has no clothes than it would to report the health board by the Indian owners. Just pay and play - it’s cheaper in the end and less hassle.)
Notice that Missling is running all of our trials outside the US. If you can’t join ‘em, go around ‘em. If the system is broken, go where it isn’t, or where it’s less broken. Everyone agrees that the science is all that matters in the end. And staying afloat long enough to prove it. So, make strategic alliances - get some big friends - MJFF, SIUF, Rett.Org, get other regulatory bodies to review your science results.
What’s the business adage: If you are an alligator and you absolutely must fight a tiger, fight him in the swamp not the jungle. Business 101. Missling knows this.
And the last thing the US political system can tolerate is being outdone on any field of battle by anyone. That’s how you beat them - put the good old USA pride on the line. Threaten them with their own reputation - make that strength the greatest weakness. The reputation which begins to vanish when you can’t claim to be the first in class at treating diseases and approving safe drugs for them, is the same reputation which will force you to approve one when it comes along. Missling knows this. The bigger they are they harder they fall. Go small - no one wants to be beaten by a small opponent, makes you look BAD.
That’s our advantage in beating the WS/FDA/BP lock up. Go smaller and smarter - be the nerd with glasses who the big jocks don’t want to lose to.
So be smart, have bigger friends, don’t go to their jungle - stay in your swamp - you call the shots and decide the terms.
When Australia/ EMA / Japan make a move...the FDA will approve on the spot. Set your Swiss stopwatch - you’re going to need a top notch timepiece cause PRECISION will matter in measuring the fractions of seconds it takes for the FDA to enact whatever it takes (Papal decree) to approve our drug on some grounds.
Look at the positive, Nidan. If the system weren’t broken, we couldn’t use that to our advantage. Knee jerk political pressure has its silver linings. I think we’re about to find out - 2 can play at any game.
Can you imagine the thought of US citizens having to travel to Europe, Australia, Japan to have their diseases treated? US doctors would be in jeopardy - the AMA would not have that. Economically, the US can not afford to turn its back on cures any longer and enable pharmacies to continue to milk a pill popping society ad infinitum in order to keep revenue streams via evergreening patents and never curing the problem. Today’s millennials see their grandparents taking 10+ pills per day with extra added side effects and they are outright rejecting that in favor of lifestyle changes. They are determined to begin in their 20’s and 30’s and educating themselves on lifestyle modifications which carry long term benefits. Eating healthy, exercise, they even set relationship “goals” to work on with their partners. The world of social media has much good to offer. There’s more to education than just science, math, literature. They have all of this at their fingertips - walk 10,000 steps/day, bike apps to use bikes to traverse the city - cheap/healthy, eating better, forgoing stressful jobs for things they are passionate about, committing to relationships and communicating expectations with respect. Wanting a better environment, sustainable/renewable awareness, clean energy, and more diversity - they understand the world and cultures better than I did at that Indian restaurant.
Even if it’s only one tiny stalk of corn...this is OUR corn, let’s nurture it.
I think our company has done very well avoiding pitfalls. The science and share price will play out accordingly.
Thank you for your input nidan, frrol, everyone, and for often indulging me,
Biostock :)
AI
