RE: New FDA Alz. Drug Review Process...Bellini
NI....."The Alzheimer's Association's request to the FDA grew out of extensive conversations with families across the nation struggling with the disease, many of whom felt that the drug development process was not always responsive to their needs. The Association held a Research Roundtable meeting in Washington at which persons with Alzheimer's, family caregivers, researchers, FDA regulators and Alzheimer's Association leaders discussed the risk and benefit trade-offs involved in drug development."
Risk benefit tradeoff with Bellinis 'Alzhemed' still wouldn't be balanceable.....Recall 'Alzhemed had never shown ANY Eficacy....even in animals there was NO Supporting evidence of mechanism of action related to efficacy or anything. (AZD-103 DOES) Phasell's.......No Efficacy! Phaselll's.....No Efficacy! Another good example of a drug that parrallels the pre-clinicals!! Thats just how Desperate they are for an Alzheimers Drug in this world.
All Bellini had after fudging around with the statistical numbers after 'Alzhemed' Phasell (recall he ommitted the drop-outs from the Final Data!!) was the almost addictive DESIRE from the patients to continue on the drug......even though it was shown that it wasn't helping them. At all.
I have mixed feelings about this FDA decision after witnessing that......but so be it. There will be a lot of failures in the latest AD drug clinicals ramp-up seen in the next few years. .......and there will be 0ne or Three that actually ameliorates the disease.
AZD-103 has an excellent chance.........Bellinis 'Alzhemed' NEVER did.