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XenaLives
JkS3, you may have this info or know where it should be.
AVXL are doing/completeing trials in a number of different countries simultaneously. Do you know who are the CRO's being used in each? Do you know if AVXL have precertitied/validated these CRO's for required crednetials proior to doing the trials. My guess is multiple CRO's in several countries, using complex technology and S/W-H/W systems starts to get to be a complexity -management issue very quickly. Simple things like REv controls and records management protocols/requirements can get hard to do while running at full speed.
So, keeping all the CRO's on the same program-time page, having evidence of each validated SW-HW system (see records/change control) are all fundamental to passing FDA-(in country) certifcation requirements.
Doing what must be done WW while trials are running AND while keeping FDA (other) certification requirements WW is a big job. I won't even mention time compression and criticality of each module or rev. controls.
Mind boggles w/trying to know where to start and how to know adequate CRO-Regulatory bodies controls are in place. Never mind doing all this against a time compressed schedule.
Any ideas if all that was done by respective in country CRO's in a AVXL program coordinated manner or if AVXL staff did such from a central control point?
TIA.
Exccellent point. He would not of course.
Mikesc
WS and BP are paid for point solutions, only. Does it work (Y/N)? If N then no value. CNS diseases do not fit that mental model, consequently we end up w/the AD, MS, MD..etc partial solution-payback -investment model. Investment is rewarded for BIG results which CNS diseases generally do not conform w/in a serial manner. No credit is given by WS for partial solutions...THEY DO NOT GET IT.
crescentmotor
I am encouraged by the spirit and languege here. AVXL needs to get a clear messge out which speaks to all AD-and CNS diseased families and clinicians. Evryone else will figure out what has just happened soon enough. AVXL has a safe and effective CNS MOA- treatment portfolio with evidnce of efficacy never seen.
We must quickly package an effective message and work with the FDA other regulatory bodies and 2nd, 3rd parties WW to move forward quickly. We are not finished but we are clearly the scientific -clinical leaders. We need to get our commercial story cleaned up and go sell it ASAP before our opponents figure out what just happened.
The scientific truth will take care of the rest .
sab63090
Lets all get synched up on this point. IMO, the sp attack we have been through is part of a planned combo (FDA/BP) move. BP/WS are scared shatless. The wide systemic consequences of an AVXL strong competitive CNS disease treatment portfolio (such as ours) linked to A Strong AVXL CNS upstream bio-med portfolio w/ efficacy will gut the existing revenue system that much WS BP is dependent on.
Is AVXL being set up for a low ball buyout ?
If you are an AVXL owner and have been paying attention then YOU MUST READ THIS PR. IMO, This explains everything that happened today (SP$$$) AND WHY? W/S and the FDA-are corrput and we all payed the price for that today. Hang in, our day will come.
https://www.zacks.com/stock/news/2025501/anavexs-avxl-lead-alzheimers-drug-meets-study-goal
We (me) have not understood the depth of the AMYLOID PLAQUE $$$ AND TIME spent over 3+ decades by our WS -BP competitors. There is absolutely NO WAY they could allow AVXL to win today. This is a far bigger issue than I thought was possible in a regulated industry. IMO, it is also CLEAR that FDA was at least silent(when they should have been commenting on AVXL results). WOW. Just connect the DOTS.
Hang in there AVXL TEAM, we are about to blow the lid off this entire 30 year cover. This knowledge also explains why our SP did what it did while the BP-SCAMMERS watched. IMO, this was all planned and AVXL team just walked right into a WS ambush.
CKENT...EXACTLY CORRECT...WGT...this explains why WS reacted as they did to our data...
This article makes it clear( IMO) that all BP and WS supporters-owners simply CANNOT ALLOW AVXL to succeed . AVXL are not ANTI AMYLOID (like all the rest) the established BP/WS system cannot allow AVXL to win. If AVXL proves they have the correct treatment then everyone else is wrong. IMO, THAT IS WHAT IS GOING ON HERE-TODAY....FDA silence is not helping, but FDA are also in bed w/the herd b/c they have also been MISGUIDED on the same AMYLOID PLAQUE path for 30+ years.
https://www.zacks.com/stock/news/2025501/anavexs-avxl-lead-alzheimers-drug-meets-study-goal
Xena? any thoughts about when the current day long SP bleed out will likely slow-stop?
TIA.
Very positive call as he reset any doubts from Friday. Liked Dr.M.'s positive (BTW) comment Re: improved PDD OLE results.
We may be finally witnessing how WW regulatory bodies (much of which are simply local interpretations of FDA pprocess disciplines applied to their own previously done local methods). We may see how they can get synched up for a common mission. We'll see how that works, trouble is we need it NOW.
AVXL may just make the point of how disjointed and dysfunctional WW regulatory bodies really are. They are not as bad as PRE ISO stds methods but below the surface most are still 20-30 years asynch. I do have confidence in Australians to drive change but not so much w/FDA due to politics and tangled conflicts between WS /NIH/Insurance cos/HC centers, etc. . Hard to determine who is REALLY focused on what the U.S. patient and families needs/interests are.
Getting the science to work/prove it works and then getting it approved by this mess defies the laws of physics/chemistry/bio/finance and common sense. IMO, the best (fastest and most effective) way forward is unclear for an entity such as AVXL. The sick folks and their families are seemingly lost in the smoke. I am glad we have Dr.M.'s patient focus B/C to rest of the herd seems to have no leadership or plan on how to acieve their targets. He has shown that can and does see above the herd and has ideas on the way forward, while all the rest are doing a ONE AT A TIME OPERATIONAL PLAN.. (which will not be done in the average life spand of humans.)
finch...I'll have to get back to you in a couple of days..
crescent
pete
pete
McM says
This is disgusting , but, it is consistent w/process of complete scientific and political failure we have all witnessed. They can continue to lie and steal and even WS will play along.
The science will eventually crush these liars. IMO, a planed movement showing RWD-RWE (patients and families) will serve as OBJECTIVE UNDENIABLE EVIDENCE of the truth. I expect them to trot out "Dementia JOE" next. PATHETIC.
IMO , we are in partnership announcement airspace about to turn downwind on runway SP$$ 2000 right.....
Plexrec:
+35% is a good day
McM
McM
McM...
KK, hang in. We need you around....
MycroftHomes:
1950jtom
crescenmotor
crescenmotor
williamssc
xodcode:
Not only WGT but it (hopefully) marks the end of money-resources being wasted on Amyloid Plaque trials. We have finite resources which should no longer be used on a 30YR OLD thesis which has never yet produced anything close to AVXL results.
Suggest this is a good time for the FDA to be asked why they have held on to the plaque thesis long after it was obviously going nowhere?
A new beginning for family members who have been through a medical hell. This will be a new -MID AIR RESTART- for many and hopefully for the RSD kids and other CNS disease folks in time.
GOD BLESS the AVXL team and all who helped to get us to this point. WGT...
If there is a PR, you can access it here:
https://www.anavex.com/news-events-updates
Thx but looking for a phone link or whatever will get me into the call
Can some one please post a link for the 7:30 PM EST AVXL CRAD readout-Dr.MAC status readout
Thank you...
Starting to peel the onion on 3+ decades of fraud....needs to include FDA failures in scope and execution...
powerwalker ref: THX...IMO, this is a coded message/integration of what Dr. Peter Senge describes , "The fifth discipline". Where he describes the different levels of knowledge...This is an acknowledgment of ..."knowing what they do not know, and they know they do not know them".