RE:Yesterday's Adcom Contradicted FDA Guidance from 2013I wonder how many fully completed, universally safe, durable response, statistically robust, single arm refractory to BCG trials were collecting dust on the shelf at the time that this eye opening FDA And Urological Association guidance was issued ???
There is no re do on the Adcomm and if they couldn't reasonably address the critical question at hand, how could they be expected to deal with these ancient findings of 2013s opinion leaders.