Simufilam Merits Accelerated Approval
The FDA gave accelerated approval to aducanumab on the basis of a surrogate, although, in a large trial aducanumab did not slow cognitive decline and exhibited damaging SAE’S (brain bleeds etc), and furthermore, notwithstanding a negative vote of 29/30 members of ADCOM.
Why ? Apparently, the FDA were desperate to give an impression of progress because, notwithstanding many past efforts over many years, alzheimers remains incurable.
In contrast, Simufilam actually does slow cognitive decline -in one year, a highly significant 8 % swing over historic norms (by meta analysis) ---- without any damaging side effects. Additionally, it reduces several AZ biomarkers at a high level of significance.
As Simufilam does no harm, ethically Cassava should apply for accelerated approval now enabling patients access while the 18 month ph 3 trial is ongoing, providing a riskless opportunity of saving many hundreds of thousands of lives otherwise lost in the interim$Cassava Sciences Inc(SAVA)$
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Comments
FDA gave accelerated approval?? means FDA can be manipulated? alzheimers: instead of finding a cure. fine a prevention!! find a way to detect and prevent before AD happens