Every morning when the Sun comes up, one half of the Alzheimer’s population of the World slides inexorably further into darkness. This situation doesn’t have to exist and is on the heads of the Regulatory Health Care institutions.
I hope they get a good nights sleep tonight as Blarcamesine sits in little bottles in a manufacturing facility.
Compared to the Adni population for Alzheimer’s, the Blarcamesine group held up much better over the 144 weeks, while Adni declined significantly. There is no perceptible change in decline and time saved is 18 months for the ITT group.
Wild type Sig 1 AB3 Clear cohort and Col 24a1 gene patients almost approximated normal healthy aging. That’s as close to a cure for Alzherimer’s that has ever been seen and good enough to make anyone want to try it. Those two genes are required for proper Sigma 1 activation in autophagy flux and give a 48.7 % clinical benefit over placebo decline.
In the AB3 clear and Col24a1 cohort, at the end of the trial the quality of life was better than at baseline.
With alternative Mabs offering lumbar punctures, pet and MRI’s scans, aria, monthly infusions and bleeding with imperceptible results.
Educated patients wouldn’t go near a Mab treatment with Blarcamesine available. Maybe that’s why big pharma will control things as much as money will allow to prevent blarcamesine from getting to market?
As for the CHMP using a “rigid pass fail analysis”
That is accurate. They hid behind their process and pretended it didn’t happen.
It didn’t concern them that millions of people are dying from this disease? That perhaps they should spend another few hours looking at the new data?
All my posts are my opinion only and shouldn’t be used for decisions regarding purchasing or selling.
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