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Biostockclub

07/28/18 6:26 PM

#160299 RE: falconer66a #160297

Yes, falconer, nice.

And while we wait and see the interplay among the various US stakeholders, if this is approved in Australia first and reluctant FDA, might I add the following:

Airfare from US to Australia among the various commercial airlines in US will be impacted also! And share price of these will reflect that they will become a major player in disease treatment!, as transporting Alzheimer’s patients to AU will become a thriving business! Just as UPS and FedEx became “super responder” offshoots with Amazon and eBay and all online ordering business, folks will take their loved ones and head down under to keep them from getting worse or for miraculous improvement.

I daresay when travel agents and airlines and cruise lines offer the “remembrance” specials (or neuronal rejuvenation packages - just doesn’t have the same marketing ring, imo, but...) The “Welcome Back” Voyage...

We will see “Alz-exit”! The mass exodus of US citizens traveling to a far away place for their medicine.

America will experience one helluva shock and awe diaspora, at that time.

I’d jump ship to keep my wits. Would you?

Thanks for the write up - save me some popcorn (and tray tables down),
Biostock

Amatuer17

07/28/18 7:59 PM

#160322 RE: falconer66a #160297

One key issue - the trial is not a Phase 3 - it is P2/3 - which means based on results they will try to convert into P3 - may need another confirmatory trial unless the results are extraordinary

Talon38

07/29/18 12:43 AM

#160351 RE: falconer66a #160297

Falconer, your discussion on why Australia will lead in clinical trials of 2-73 rings true. It may, at its core, highlight a country that has pretty much had to get things done on its own since the days when it was the British Empire's penal colony. It's epitomized by "Get it done mate"! Contrast with the NIH's press releases about how tough it is to recruit clinical trials workers and participants below.which for example has this obtuse fluff......

"Developing a Science of Recruitment focused on supporting investigators, in collaboration with communities, to develop and test innovative strategies and build an evidence base of effective participant recruitment and retention methods." Get it done mate!

https://alz.org/aaic/releases_2018/AAIC18-Mon-clinical-trials.asp

Dr Hodes, the NIA head was a keynote AAIC speaker but seems to have forgotten to mention the ACTC which is his Agency's prime Alzheimer's clinical initiative. I still believe that Scott and Janet will push, drag and kick the FDA and CDER to keep abreast of the science. Australia giving approval for 2-73 while the FDA doesn't have a robust P3 under way will not escape POTUS's stinging tweets.

And by the way, The AAIC did not to my knowledge put out a press release on 2-73 while it did one on BAN2401

--------

Richard Hodes, M.D.

Theme: Public Health and Psychosocial / Health Economics and Policy
The Winds of Change: Transformative Data Resources for Alzheimer's Research

Richard J. Hodes, M.D., is the Director of the National Institute on Aging (NIA) at the National Institutes of Health (NIH). Dr. Hodes, a leading researcher in the field of immunology, was named to head the NIA in 1993.

The NIA leads the Federal effort supporting and conducting research on the biological, clinical, behavioral and social aspects of aging. Dr. Hodes has devoted his tenure to the development of a strong, diverse, and balanced research program. This has led to new and innovative ways to conduct research, share data and translate findings into practice. Dr. Hodes also directs the federal effort to find effective ways to treat or prevent Alzheimer's disease, as the NIA is the lead NIH institute for this mission. Cutting edge research conducted and supported by the NIA, often in collaboration across institutes at the NIH, has helped to revolutionize the way we think about Alzheimer's disease and related dementias. Studies in genetics, basic mechanisms, imaging and biomarkers have spurred the development of potential therapies aimed at a variety of targets and the testing of interventions at the earliest signs of disease.

nidan7500

07/29/18 5:31 PM

#160461 RE: falconer66a #160297

falconer

Here’s the central question. Where is Anvex 2-73 most likely to first gain governmental approval for generalized medical use? Is the US FDA set up for and promoting such an outcome? Or, perhaps, are things more propitiously arranged and aligned in Australia?



I think we learned from this AAIC 2018 cycle that science has and can be pushed aside by other interest. It ain't pretty but there it is. Government approval and public acceptance varies as a function of science, credibility, image and politics. We have primarily focused on science think, hey of we got the goods it will all work out. I hope we just saw how even lousy science can win (define winning) with the right PR-politics and credibility (which is code for well placed money).True, eventually the science has to take the day but we may all be dead by then.