Anavex Life Sciences Corp (AVXL)

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http://www.sciencemag.org/news/2018/02/fda-floats-new-rules-testing-alzheimers-drugs

These draft guidances, which will have to be formally reviewed with time to gather more feedback from patients, physicians and developers, come after a drumbeat of late-stage failures is raising questions about what scientists actually know about this disease. Eli Lilly tried three times to produce pivotal evidence that solanezumab could influence the course of the disease by clearing amyloid ß, and failed. The company now has sola in a study to see if it can prevent the disease in at-risk patients.

Earlier this week Merck flagged a clear failure for its BACE drug verubecestat, which moves upstream in the biology of developing amyloid ß. It has now failed in both mild-to-moderate as well as prodromal patients. Axovant took a failed drug from GlaxoSmithKline and smashed into a subgroup flop recently, leaving the biotech badly wounded. And Pfizer added to the latest series of setbacks with its decision to dump its entire neurosciences effort and move on in other areas — following the exits of big players like AstraZeneca and GlaxoSmithKline over the years.

That doesn’t mean that R&D has stopped. Any new drug that can help patients, or patients at risk, is likely to be a blockbuster winner, and that has helped fill the cash reserves of new biotechs like Denali, lining up with longterm players like Takeda, which had its own recent setback.

The march to studying drugs at an earlier and earlier stage of the disease has been underway now for at least 5 years, so the move toward presymptomatic groups is a natural step in that evolution. However, shifting away from gold standard endpoints toward an evolving set of biomarkers also raises the prospect that the FDA will approve new drugs that eventually prove that they don’t actually do anything to affect the course of the disease, raising hopes and costing billions without any real benefit.

Standing still, though, is no longer an option.

The emphasis at the FDA now is to encourage successful drug development by recognized experts. If they start toeing the line on professional standards for efficacy and safety, you can expect to see the pendulum swing back again sometime in the future.

Reprinted from Endpoints News. Copyright 2018. Endpoints News reports and analyzes the top global biotech and pharmaceutical R&D news of the day. Sign up for its free reports at https://endpts.com/

This article is repeating many of the AVXL advocate thoughts posted here over the past year or so. Both FDA and BP have totally missed any target and have now left the field. Dr. M. and others have proposed a model (CNS cellular homeostasis) which they claim will allow regeneration and restoration of function (to some degree).

The basic facts are still in our favor and the reasoning any have presented here about the science not being contradicted is strong and further validated by publications like this. A good question for the AVXL doubters might be..."Why did BP continue on the Amyloid path for decades after evidence showed it was clearly wrong?" "What is the benefit to having ANY of those people at the table moving forward?".

Do some of us doubt the process is rational and objective? Hell yes, and for very good reason. What does any of this have to do with AVXL SP?
BTW, the same question still exists. Who gets fired if AD and other CNS diseases remain untreatable?