The big question for Anavex.
The only thing that really matters to Anavex Life Sciences Corp, and its shareholders, is the eventual ability to sell blarcamesine somewhere in the world, for some recognized or authorized therapeutic protocol. The intellectual jousting we engage in here are both sophomoric and irrelevant.
Sales of the drug first requires sales and use approval from some country’s drug regulatory agency; which most likely will be first with the US FDA or the Australian TGA (Therapeutic Goods Administration). With that, Anavex gains operating revenues; becomes a functioning pharmaceutical company.
But approval by the FDA or TGA requires the presentation of positive human clinical trial data confirming both safety and efficacy. Data and findings from murine studies from any number other drugs acting putatively in the manner of the Anavex molecules will be utterly disregarded; won’t even be submitted. For approval of blarcamesine, murine studies are irrelevant. Only human data from properly-conducted trials are considered.
Other drugs, however, will enter into the sales and use approval decision-making process. To be approved, a new drug must show not only safety and efficacy, but also match or exceed the existing standard of care (SOC) drugs for the targeted diseases or conditions. For Alzheimer’s, there are a few being prescribed. The Anavex drug, in the large, definitive clinical trial (now under way) will have to show that it matches or exceeds the data for Aricept (donepezil), the presently most-prescribed drug to treat Alzheimer’s.
How will blarcamesine’s therapeutic data compare to those of Aricept? Look it up. Aricept works, but only to a degree, and only for a short or moderate period. It has the ability to slow the progression of Alzheimer’s symptoms, but only for a period. Eventually, the drug fails to work, symptoms progress lethally.
When the definitive blarcamesine-against-Alzheimer’s trial ends (some time next year), will it prove better or worse than Aricept? I maintain my AVXL position based upon all of the both murine and human trials data. Not a scintilla of evidence that it will turn out worse than Aricept; quite the opposite.
