RE:FDA Approval with Conditions in 2016?Approval in Feb 2016 with some sort of " patient refusal to cystectomy" condition. That's what the panel were getting at yesterday, I would say. I think about 6 or 8 panelists would have voted for it if this was in the question. No matter how you slice it , MCNA is the only drug out there now. Valrubicin (sp?) is worthless and MCNA is light years ahead of this FDA approved drug in efficacy and especially safety. That's what kills me.
FDA will do the politically correct thing and approve in Feb , as there is a dire unmet need for this. Maybe politically correctness can be in my favor for once in my life.
Oh well gotta wait a couple more months. I'm not going to look at this til after Xmas, giving me a headache.
GLTALongs
13PD