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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