RE:RE:"Efficacy and Safety of MCNA in Patients".... - ArticleThanks,
Interesting how doctors specifically working in this field (Urology) came to these conclusions but the Adcomm panel could not. Kinda makes you wonder why they were there. Sound like a "no" is the default answer when you are not really sure how to vote.
The Telesta team got caught flat-footed and failed to convince the panel. I still believe they thought this was a slam-dunk based on previous discussions with FDA. The question is how much faith does the FDA put into the Adcomm panel and how do they regain the trust of the FDA after their failure at Adcomm?
This should be approved, the question is does the FDA loose face granting approval after an Adcomm "no" vote?