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IMO, SAVA may well be a poster child for what is wrong with WS-BIO PHARMA investing .
TempePhil
11.20 +0.33 (+3.04%)
Pre-Market: 09:06AM EDT
Does this suggest an AB-E-NORMAL DAY IS ABOUT TO START??
Gerogejji...I hate to be the one to break this to you but...yes AVXL is required to comply w/such basic requirements. How are AVXL able to identify and assess that their suppliers have adequate controls? This is even more important when the CRO sites are WW. Please assess this further. AVXL is a potential drug supplier, these rules apply directly to their FDA-V&V compliance requirements...(or they are a special case?).
Perhaps the recently hired AVXL Quality manager could help explain how this is/has/will be done. Again, not trying to be difficult but this is basic requirement.
Please note.
These are NOT....NICE to HAVE ...this is the FED. LAW.
georgejji
It is fundamental that any labs used must comply w/FDA requirements when the outputs/data will be used as evidence of compliance w/trial end points.
Start w/21 CFR parts 210/211. EX 211.186, Master control of records. ..systems V&V for change controls/training requirements/basics. All of relevant (see scope of work) Lab controls/(subI), Records and reports Sub J, . Apply all of 21 CFR parts 210&211 as directed by an assessment for systems scope and requirements for lab controls. All 21 CFR part 11 (control of electronic records/signatures). Applicable sections of ISO 17025-testing, ISO 17025 competence and testing.
That is just the beginning. These requirements would be fundamental to the qualification and acceptance of any resource used for compliance acceptance. There is a lot more, but suffice to say this is just not the time to have the discussion. All of that would have been completed long before any lab/test resources could be considered for test services w/this level of criticality.
georgejjl
Rubyred77:
xodcode
Xodcode:
plexrec
test reply only
Very well done to all involved...
Ariana Pharma issued a press release earlier this week regarding the blarcamesine gene pathway data analysis presented at AAIC back in late July: https://www.arianapharma.com/ai-driven-analysis-of-parkinsons-disease-dementia-clinical-trial-reveals-potential-molecular-mechanism-of-blarcamesine-anavex2-73-in-restoring-key-neurodegenerative-pathways/
https://www.arianapharma.com/ai-driven-analysis-of-parkinsons-disease-dementia-clinical-trial-reveals-potential-molecular-mechanism-of-blarcamesine-anavex2-73-in-restoring-key-neurodegenerative-pathways/
No Shat...??...
Well Done georgejjl...thx... I add my own shareholder interests and emphasis to your request message.
Is it healthy-OK to hate a tape -stock color? RED for example.
Best case, Sava and others to follow, represent the beginning of a technology evolution which was certain to follow once AMYLOID has finally been buried. This starting new evolution is WAY LONG OVERDUE. ... and has a long-long way to go before being converted into consistently useful products for effective CNS treatment (s).
The good news is, AVXL is on the tip of the spear of a change process which we will move quickly at first. We will lead the way and may/likely lead for decades to follow. We have/control the MOA keys to the way forward .
A useful analogy comes to mind from the electronics field. In the 60's the first semiconductor devices started to be developed . Vacuum tube technology held out for a few last years until the development of competitive/reliable semi-devices progressed into early 70's and then BOOM...who can forget their first..."TRANSISTOR " radio. That was 50+ years ago and that change/evolutionary process is still ongoing .
Somehow the medical-pharma industry been able to resist change & evolution (see FDA) but will now start to catch up. Take a deep breath...IMO, Dr.M. and team are way ahead on this curve. I would agree that AVXL probably should have rolled out a larger tech/management team sooner but IMO, that is an easier gap to fill than what our competitions curve will look like when they begin to climb our science curve ripe w/patents and a scope of the AVXL CNS diseases applications.
STANDBY...pilots and crews , man your airplanes.
Continue to move the AD -CNS solution upstream....finally.
Can we assume that today's PM pop in ANVS can be taken as evidence the FDA has finally given up beating the Amaloid horse to death? Now what?
Xena...are we still sitting on a goldmine here ? Everything is lined up for ....BOOM. tia
abew4me
OK...now we have to get to work and be ready to define-declare the OFFICIAL ...
CNS DISEASE AAAHHHHHAAA MOMENT. (Analogy to the ...ANTI-BIOTIC AAHAAA ...petri dish moment decades ago)...stand by.
Good to see this kind of work paying off, even if it is exactly what BIIB...FDA etal do not want to hear. How does a large group of highly trained/skilled and very smart people end up on the wrong track-(DEAD ENDED) after decades of research??)
https://flip.it/NwI46q Decreased Proteins, Not Amyloid Plaques, Tied To Alzheimer’s Disease
Nice connection to point out, thank you.
This points to what we have seen with consistent results across many studies where NO CONTRADICTIONS have been noted . Seem to be a harmony in conclusion where different teams have concluded similar results even though they took various paths. Thanks and well done. AVXL may be about collaborate and to declare that CNS AAAHAA MOMENT.
JWC3
treden
Someone recently posted a message here which predicted a big drop in AVXL WS transactions this week B/C of ???, cannot recall...if anyone has that link or message can you please repost it...turns out it described exactly what we are seeing today...IMO..TIA
mauismart
I have worked and studied w/a set of people (science deep thinkers) like Dr.M. over some years. god bless them, they can often more interested in the beauty of the science and the results than the...immediate ."What's Next???". Believe it or not they can end up loosing track or the ..."SO WHAT'S".
So, just my observation but beware the "news cycle" motivation (gene) may misfire as the ..."Ain't science grand" fog dissipates." It just is what it is"... head set...we need to accelerate a little.
Pete said
Good example of contradiction (Amyloid Plaque) ...which we (upstream AVXL people) have been talking about for a while here . Such contradictions cannot be simply ignored and yet, they have been for 30+ years that we know of.
jjones