NurOwn Adcomm Is 20 Members Strong Despite US FDA’s ‘Struggle’ To Find Unconflicted Neurology Experts
Seven panelists are regular members of the Cellular, Tissue and Gene Therapies advisory committee, while many of the 13 temporary voting members bring neurology and neuroscience expertise. In a conflict-of-interest waiver, the agency noted a struggle to find experts in clinical neurology and neurodegenerative diseases who lack disqualifying financial interests.
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Arizona State University neural transplantation expert Jeffrey Kordower said FDA requested he not participate in the advisory committee because of his relationship with sponsor BrainStorm. Kordower says a 2022 journal article erroneously stated he had an ownership interest in the company.
Sponsor’s assertion of a ‘floor effect’ cannot explain the lack of difference versus placebo on clinical endpoints, and there is no evidence that assessed biomarkers are reasonably likely to predict clinical benefit, agency says. Although advisory committee will focus primarily on efficacy, FDA also cites concerns about ‘grossly deficient’ product quality information.
Late recusal of several potential panelists was the result of a recent docket submission containing a December research community letter signed by dozens of Alzheimer’s experts, FDA said; signatories included neurologist David Weisman, who had received a conflict-of-interest waiver that cited his role in a Phase II lecanemab study but not in an ongoing Phase III study.