Shares of EDAP TMS S.A. (EDAP -21.5%) drop on a 3x surge in volume. Earlier today, the FDA released its briefing documents for Wednesday's meeting of the Gastroenterology and Urology Devices Panel. The Committee will discuss the company's PMA for the use of Ablatherm HIFU as a treatment for prostate cancer.
Investors appear to lack confidence in a positive vote. The agency's comments in the documents imply that reviewers have numerous questions/issues that need to be resolved regarding its clinical trial data.