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Mike..
Kevin...agree and [quoteAll biotech will be supercharged via improved bureaucratic efficiency at the FDA.
][/quote]
I believe the overall risks for investors will be lower in biotech due to the process changes and requirements of precision (prep) medicine. There may be a loss for those who do not even make the PII to III cut. Those trials which formerly might have made the cut to PIII may not w/new process requirements and acceptance criteria. If true we should benefit although it may take a while for this to play out.
At some point a retrospective review of historical big AD losers against new criteria would be interesting. This is going t put a lot of pressure on the FDA, as it should.
[quoteLook anyone who thinks biotech is an efficient market and the share price is your guide to "value" is a moron.
][/quote]
Excellent
Thx...I am reading it as positive also...2 wks is good w/me
On the bright side, I think (if/when) the new FDA process guidance is written and implemented we will see a MUCH lower risk investment profile. Not just for AVXL but all Biotec's.
We should see stronger PIII prep/analysis work where sponsors/operators and FDA understand better/exactly what they are looking for. There should be fewer failures and (BTW) fewer attempts by those who do not make the cut. FUD should decrease as the antidote(s) information, knowledge and competence kick in.
Maybe biotec investment will be as predictable as GE or CSCO.
Anyone see the extension date? New due date ...IS _______?
Extension granted...
https://ih.advfn.com/p.php?pid=nmona&article=76380132
Exactly...it's complicated.
Past FDA CNS trial guidance has been a failure . We believed Dr. G. when he said these new guidelines were going to be changed. When???? What method/trials/examples will be used to validate the new guidance process rules? What confidence levels should we expect? Are investors supposed to continue to follow a CNS trials process that is clearly a failure or should we just buy lottery tickets instead?
We expect A2-73 to be effective and to see efforts going into V&V. Continuing to throw our investment money, time, resources and patient lives into the current FDA CNS hopper is just dumb. Precision medicine pharma trials are a step in the right direction. The FDA needs to do what it said it was going to do.
If we do not push for effective use of resources, who will?
Talon Thanks...I remember and old expression ..."Leadership is like pornography, it is hard to describe, but you know it when you see it".
IS ACTC code for leadership? Can they answer the question..." Why is a company like BIIB (allowed to) still chase the AD Plaque illusion when we have limited resources (staff/pts/sites) to do such things?
I hope we see a plan, dates, schedules, commitments, resources and most of all some one or a group who will identify priorities, schedules, results along with activities of leading. I expect that academics bring a lot of knowledge and good thoughts on how to be supportive. I am looking for someone(Central control) to stick up their hand and declare they have the job and will take responsibility for the effective treatment of CNS diseases. Right now we have a herd of investors/Hedge funds/MM/micro/macro biotec/BP/3rd parties (like MJF), academics/FDA and various WW regulators w/o a plan. They are leaderless. In the U.S. it looks like BP/hedgies/MM/and FDA have a closed loop on who/what gets promoted/done.
Simply trusting that eventually a company like AVXL will produce results is where we are now. Biotec investing is an extremely risky act of faith, we all get that. Any assessment of the FDA pharma new device/pharma approvals process for AD (and other CNS) would declare it to be a complete failure for at least the past 40 years. Lets hope ACTC is truly a new beginning and not just building on what is now in place. IMO, Gottlieb has to do this.
Thx
Talon, you suggest the beginning of leadership by ACTC. Do you think they will decide/influence the trial priorities based on society critical need/probability of success/acceptance criteria/timeines and such leadership notions?
It would be good to see someone take the wheel to interface w/FDA decision processes for approvals and to mitigate BP influence.
Talon, as a pilot you understand pilot In Control/Command (PIC). It looks to me like no one is flying this airplane.
I'm good thanks anyways
Huh, over the past year or so we have periods of no trade days so the recent activity seemed an improvement. No info available on product/FDA position or any trials. TBD.
Any thoughts on recent price/volume activities?
Green...pls provide link. Thx
Tradeh...You are correct. A similar thought hit me as I was studying a piece posted by penny double which described how a NEW FDA process was going to function. I had flashbacks when I read it. This is how (any) technical/regulatory/business interface process works. This kind of process has not changed in 100 years except to add more details/facts/quicker and more accurately, which sounds good but in fact it adds complexity, etc, etc. IMO, the whole lab rat/invitro trials thing is in the way.
If somehow we could recognize that this crisis (CNS diseases) is killing us and it is getting worse. Our methods need to be changed to at LEAST reflect to scope of this issue. This is not a freaking GAME here. The resources being expended do not reflect the severity of the issues.
I also concluded (maybe in error) that the REAL function of the FDA in this context has been to write enough rules and processes to keep decision processes focused on being SAFE and EFFECTIVE (not fast). BP likes this in a way b/c it functions to limit their legal exposure..."Hey, we are FDA approved"...do not blame us. In the meantime kids/adults w/CNS issues are not getting treated but the FDA and BP all have their jobs still. In other words, this process is not working to solve THE PROBLEM of CNS diseases. Just telling patients they are UNTREATABLE is not good enough.
So, it always ends up being a money discussion. BP is the only group with enough $$$ to even do testing/trials according to historical conventions and protocols. (BUT, why should they if it hurts them?) The FDA has no money and sees itself as the safety gatekeeper. Who advocates for the individual patients? If the central government were not so corrupt and incompetent it could help. This needs to be fixed in the private sector. IMO, Gottlieb, Dr. M and others could probably figure out a good/low risk faster way out of the swamp but not by using conventional methods. Unless a massive amt. of money is thrown in the pot we will probably stay where we are. My hope is that A2-73 starts us down the better, shorter path but unless there is proper incentive it will take a very long time to offset the drag of the existing system.
investor...BINGO..."fool me once" ...new moto for M..
Big P uses the FDA to stay out of jail. The FDA uses processes, committees and experts, documented-step x step rules based (sit in a room and debate) rules, all of which must be followed. The rules are nominally based on .."The List of everything that ever went wrong"...which is sacred to all such functions. There is always some guy in the room who will point out "WHY it MUST BE SO".
Even when great concepts are agreed to the next step is to write it all down and to develop the sequence, check points, test criteria, etc. They can not help them selves.
The FDA feels obligated to do what they have always done(rules based processing) to keep a big mistake(ref. thalidomide sp?) from causing harm and to keep their jobs. BP does basically what they are told after the obligatory debate. (This is how labels and labeling were born) It is nothing new,the technicals vs the process guys. Gottlieb and M should have known better before they opened their mouths describing what was "POSSIBLE", before the process guys got wind of it. "Sure-go ahead-break all the rules"...see you in Levenworth prison.
A little harsh on M.
This whole thing is about money. Period. The FDA is the/a gatekeeper. I see their job as one to provide rules/laws which control the development of products medical devices and Pharma's. They do this by keeping their jobs and not simultaneously pissing everyone off.
BP has all the money and will sell anything to anybody as long as they do not get sued. FDA tries to write rules and draw the line which allows sufficient financial incentives through process controls/rules which we know as regulations. But, it is really all about money. BTW, the ONLY people with enough money to follow these rules are in BP. So, there it is, a standoff. This can be known as the SWAMP.
Now, how is a company like AVXL going to make it through the SWAMP of corruption and maze of rules w/o getting eaten alive? Good question. Keep in mind the ONLY people who really care are the patients and their families and shareholders. All the rest of are a kind of observers/baggage. Sometimes they help, like MJF foundation does as 3rd party watchdog.
We are stuck in the swamp along w/M and the whole lot. You should assess the rules guys also. Just what the hell is the FDA doing anyways? It is clear the process so far has produced more of the same. The process only functions to avoid disasters and to save/keep jobs in BP and FDA.
I am somehow confident that A2-73 will make it through but it will not be by following these rules sadly (See Aus/EU). If anyone will make it M will.IMO.
Xena...post #135202 sounds like what you said was going to happen...
Investor...thanks...this is a learning process playing out for the world to see. If we are right, books will be written, etc.
What fascinates me (I am not qualified to discuss...but I will anyways). Dr. M. has taken the concept of CNS Homeostasis as a CNS solution hypothesis to explain and assess what must be happening. Brilliant, he just declared that must be true and has worked/developed the restore/regen model and rational. So far no contradictions as it addresses the root cause of PD/AD/MS/Epilepsy/RETT. He did this while the whole rest of the medical world has been on a different failed symptomatic treatment path. A true gutsy path. If he is right my grandchildren will have a much richer life than my own.
Thx, We are saying about the same.
Is it possible that as the clinical (trials) learning process has gone forward and the (DNA/GUT/other) data from serialized pts produced certain key new information (importance was unknown when they began)?
Then, they all agreed that the new knowledge was critical and must be understood. That stopped the trial planning? Like all processes when discovery is happening they would have had to convert the new information into something meaningful and relevant for evaluation. The new FDA trials guidance will reflect this new knowledge. IMO.
Meanwhile, with a room full of smart people (some regulatory w/influence) a dynamic is expected where new knowledge is tested/argued. Fill in the blanks for yourself.
Of course something like that has occurred wA2-73 AD results and that process will repeat itself for the next few years. There will be (maybe already has) a Breakthrough. Follow on BT won't take so long as the results become more certain and predictable. I think that is what the FDA-ACTC is supposed to help with but it has not been there the past 30 years. Of course the process was slowed/held while they figured out what to do. It would have been nice to have anticipated that before the, " 3 trials" , announcement. I am optimistic we have a BTD, if A2-73 was a dud they would have stopped looking. The delay sucks but it is actually a good sign, IMO.
Good news is (IMO) the new outcome is more predicable, approaching certainty. Eventually we will see effective AD treatments. While, in the meantime, I expect RETT, PD and other indications to move quicker but essentially on the same kind of learning curve. The trial and error days are gone.
I would expect at some point soon (If this all works out) that AVXL is platinum rated investment as smart people get on board. BP is in deep shat. The new trials processes will also make it clear why the past 30 years or so of enormous expense and painfully weak BP processes failed so badly.
Yup, you are correct. That whole WSU report- BIIB A2-73 test-silence thing remains a mystery. Do not have a good sense of how BIIB does business(particularly with micro biotech's). My opinion is Dr. M. knows he has a winner and this ain't his first rodeo.
Hey....we are GREEN at 10:xx....
and, something biblical for you to consider during the season...and for the new year.
Go forth and multiply...
IMO, This PR states that BIIB (others) have reached the end of the plaque rope and it has AVXL written all over it.
BIIB AD News today...not so much...will not paste here for some reason...makes you think a little about RWE as an alternative might present...
WOW Bio...Well done.
Possible repeat post from street.com today: