Anavex Life Sciences Corp (AVXL)

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Factors in FDA Approval of Blarcamesine

I mean if we seriously consider the fact that the Fda has been studying our drugs path of travel closer then hurricane Irma then is there anyway they are handing out “participation” trophy’s....

On this board there have been many postings describing the putative closed-door machinations of the FDA and Big Pharmas that will somehow keep blarcamesine off pharmacy shelves. To let blarcamesine get approved endangers all sorts of financial arrangements and understandings. Or so it might seem.

My expertise is in cellular biology and its related topics. I have no particular competency in corporate finance and regulation. Might there be some closed-door underhandedness going on between certain FDA parties with certain corporate interests? Others will have to clarify the matter.

From my perspective, the biology of blarcamesine is profound and will control; it will transform 21st century medicine more than antibiotics did 70 and 60 years ago. Before then, if you got an infection your chances of dying were very high. Antibiotics changed all of that.

Now, the Big Change will be blarcamesine. An early diagnosis of dementia, either from Parkinson’s disease or Alzheimer’s disease, will no longer be so alarming. Today (as happened with my father) a diagnosis of Alzheimer’s means months and years of great suffering, both physical and financial; with no hope whatsoever. My father was actually in the final clinical trial of Aricept, and it got approved. But with no real benefit. My father’s demise might have been slowed for a time (if so, its slowing was imperceptible).

His demise was quietly arranged. My mother was a recognized, accomplished geriatrics nurse. She worked closely with the physician attending my demented father. One morning I got a call from my mother; she said I had to travel back home, as “Dad was dying.” A few hours later I was at his bedside as he so quietly expired. I’m certain that the physician and my mother agreed to “reduce Dad’s pain” with a “sufficient dose” of a “pain killer.” Euthanasia, it was; thankfully. For weeks Dad’s sufferings had intensified; utterly pitiful. His facilitated, quiet passing was a relief for all.

With the approval of blarcamesine, all that will be obviated for so many. Sure, it will make the existing Alzheimer’s drugs, such as Aricept or Aduhelm, economically unviable. Blarcamesine will be the global SOC, standard of care for senile dementias. In fact, in the majority of cases the drug will not slow but actually reverse the progression of cognitive impairment. Soon enough, it will be discovered and understood that blarcamesine therapy needs to commence at the earliest indications of cognitive impairment — prophylaxis. With blarcamesine in either case, before dementia sets in to any debilitating degree, or even after Alzheimer’s is fully developed, the drug will be profoundly therapeutic. Nothing else like it.

And that’s what will be the making (well, approval) of the drug. When the full results of the now-concluding clinical trial are released, everyone touched by Alzheimer’s in any way (tens of millions) will expect and demand the drug’s approval. The comparisons will prevail. Aricept, to but a slight degree, slows, but does not stop the lethal progression of Alzheimer’s. Aduhelm, essentially, yields the same outcomes; which include brain swelling, etc. — at excessive, extortionary costs. Without side effects blarcamesine safely reverses cognitive decline and maintains cognition. Alzheimer’s patients being treated with blarcamesine will live on with mental health, to die of some other debility. No comparison.

When the full clinical results of blarcamesine are released, let’s watch to see how various parties react. On this message board there will be all the expected usuals who will tell us why the good results really aren’t; why the FDA needs to “require a new big Phase 4 trial.” Others (like myself), will try to elucidate the good results, and tell why they mandate FDA approval.

As I’ve contended for a long time, initially so much depends on the headlines the New York Times will write on its clinical results news article. Which might it be? “New Drug Shows Great Promise for Alzheimer’s.” Or, “New Alzheimer’s Drug Has Unknown, Questionable Chemistry.”

But, either way, Alzheimer’s associations and medical professionals will see the truth; as will their members and patients. The truth will prevail.