Concerns spurred by FDA push for ‘sham’ brain surgery trial, Bloomberg says

UniQure’s (QURE) gene therapy for Huntington’s disease has shown promising early results, but the FDA is requiring a new trial with a sham-surgery placebo group to prove its effectiveness, Bloomberg’s Gerry Smith and Robert Langre report. Some patients are reluctant to undergo fake brain surgery, leaving UniQure in a standoff with regulators over whether such a trial is ethical or feasible, according to the report, which adds that the impasse could delay U.S. approval despite the therapy’s potential to silence the disease-causing gene.