Anavex Life Sciences Corp (AVXL)

[nidan7500]

Wow, just imagine what will be written when AVXL delivers a CNS treatment that is BOTH...SAFE AND EFFECTIVE.

going long...

Adriane Fugh-Berman is a professor in the departments of pharmacology and physiology and in the department of family medicine at Georgetown University Medical Center, where she’s also the director of PharmedOut, a research and education project that promotes evidence-based prescribing.

She wrote:

A treatment that improves Alzheimer’s disease would be a great advance, but Leqembi (lecanemab), which recently received accelerated approval from the FDA, is not that drug.

Yes, lecanemab slows decline to an extent detectable on a test, but not to an extent that a relative or caretaker would notice. This drug doesn’t actually make anything better. It just slows the rate that someone goes downhill over 18 months — by less than half a point on an 18-point scale. And we don’t know whether things get better or worse after that.
...

The Alzheimer’s Association, which takes money from Biogen, called the approval of Aduhelm a “victory for people living with Alzheimer’s and their families.” Of Leqembi, the Association claims that this treatment addresses “the underlying biology of Alzheimer’s and changes the course of the disease in a meaningful way for people in the early stage” and, again without evidence, that, “Individuals will have more time to participate in daily life and live independently.”
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The Alzheimer’s Association, predictably, has been pressuring the Centers for Medicare and Medicaid Services (CMS) to have Medicare cover Leqembi. There’s no reason to think that Leqembi will be marketed any more responsibly than Aduhelm. It’s up to physicians, patients and CMS to reject an expensive drug that improves no symptoms and puts users at risk of fatal bleeds.