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Opinion: "Goliath's" Petition Versus "David's" Petition

On October 12, 2021 one Andrej Tokmakov (AT) filed a Citizen's Petition (CP) with the FDA to request "...approval of Simufilam and immediate initiation of Phase 4 trials for further efficacy, safety assessment, and, most critically, to address one of the greatest needs in modern medicine." The FDA will typically respond within 180 days of the petition being filed. AT's petition Can Be Found Here and His Supporting Attachment Can Be Found Here The FDA's Acknowledgement Letter Can Be Found Here

The FDA currently has two opposing CPs relating to SAVA. One filed by a rather large law firm on behalf of mysterious clients with a short position against SAVA. Another CP filed by a lone army of one. This is literally David versus Goliath. But given the FDA's extremely small record of actually halting a trial because of a CP, perhaps Goliath is a feckless paper tiger. It is my opinion the FDA saw no urgency or reason to formally respond to the first Citizen Petition's request that phase 3 not be allowed to begin. With Phase 3 having commenced, it seems that perhaps the FDA has informally given their response to the first CP. The FDA's silence to the first CP is profoundly loud. All signs point that David will vanquish Goliath.

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