What the procedure is after the panel discussion? Could the FDA make a decision on the spot or are we in for more months of waiting, and government BS?
I will tell you for a small favor. Shall we make a deal?
as far as i know, if the panel recommends (positive outcome = vote) HIFU on july 30th, fda will inform the company the date of pdufa within 30 days...please correct me if i'm wrong.
Sentiment: Strong Buy
Here are all the details about the upcoming July 30th panel meeting...