Argos Says FDA Willing To ADAPT To Longer Follow-Up For Immunotherapy
Executive Summary
Argos Therapeutics reports FDA support for its plan to continue its ADAPT trial of rocapuldencel-T for metastatic renal cell carcinoma despite a futility finding by the independent data monitoring committee.
You may also be interested in...
Argos Not Stopping Cancer Vaccine Study Despite Futility
The biotech suggests that ADAPT trial design was not ideally structured to show the longer-term benefit that might result from its autologous immunotherapy. Argos plans to discuss its plan with FDA in May, despite analyst skepticism.
Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says
New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.
TV Drug Ads: FDA May Pursue Further Research Before Policy Changes
US agency's study found that mentioning fewer risks in direct-to-consumer ads helped with recall and in some cases with recognition but led viewers to say they didn’t have enough information.