Replies to post #215431 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Millie Varoom Says:

No pain, no gain.

Anavex has the goods. They've been proceeding carefully for over four years, proving the science every step of the way.

Provisional approval out of Austraila (followed by Canada, Britain, and the EU..... and finally in the US.) is a reasonable expectation. The question is 1/1/2020 +- how many weeks.

With a company that has groundbreaking science it is only a matter of time till price follows.

[nidan7500]

LB19 - Novel analytics framework for augmenting single-arm Phase 2a open label trials with Real-World external control data:
Application to the Blarcamesine (ANAVEX®2-73) study in Alzheimer’s disease matched with propensity corrected patients from Alzheimer’s Disease Neuroimaging Initiative (ADNI) exploring treatment effect on cognition at Interim two-year (104-Week) timepoint

Mohammad Afshar (1), Coralie Williams (1), Nanthara Sritharan (1), Frederic Parmentier (1), Federico Goodsaid (2),
Christopher Missling (3)
(1) Ariana Pharma, France, (2) Regulatory Pathfinders, United States, (3) Anavex, United States

Patent for AVXL re (hypothetical) use of ERP devices to conduct remote monitor outpatients w/AD clinical evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141316

Cognision is a member of consortium team w/AVXL/many others.

If PET scan may be used w/a validated system for identifying and monitoring AD then the clinical cycle has begun to take shape. AKA dot connecting.

AVXL and team may establish an alternative patient system cycle flow which includes capability to remotely monitor AD patients after the PET SCAN imaging confirms early diagnosis of AD patient, which presently cannot be done. B/C (for example) FDA has said , "we really do not know how to determine exactly when AD begins".(ridiculous on a scale of 3-5 years). So, come back when you are already hopelessly screwed (b/c there is no treatment) and then we will hook you up w/a DZP sales guy.

So, here's the plan. Patient gets consulted/confirmed as early AD by use of new science(see paper-presentation). Monitoring begins using various ERP/AI remote monitoring systems. Patient is treated as out patient,(see patent app.) not warehoused. Patient dosed w/A2-73 following complete assessment. PET SCAN of t=0 completed. Out-Patient continues treatment-dosing . Remote monitoring w/ERP clinical non intrusive devices, RWE-RWD-EHR wireless remote established. Out-Patient continues to be treated until stable, recovery cycle is established. Continue treatment until patients cycle can be altered.

IMO, that is where this will go and all the pieces are in place or are getting there. IMO, many new health care system for CNS diseases will be done in a similar fashion. Unused dementia warehouses will be converted to ice rinks or other suitable plans.

We must listen to what the speakers mean in addition to what they actually say. The science is leading the application, as it should do. If PET scans can be used as a tool to verify AD early and to monitor (not for Amyloid search) then this system works. If there is no A2-73 effective treatment for CNS then it is all just vapor. IMO, they would not even be discussing this approach if they did not have strong evidence of efficacy already.

IMO, Dr.M. and others have not only determined they have a product for treating CNS diseases but they have also developed a program for how to apply and roll-out the product for most effective treatment. This is about QOL. This is how to use it b/c none of the existing infrastructure or systems support are compatible w/the new science.