Are absolutely ridiculous. I hope Titan gets a chance to address this again.
It now appears that FDA just wants some modifications to procedures presented by Titan.
Where exactly can i listen in to this presentation? is it already over? lastly where will we be able to find voting results?
What's ridiculous? The comments or Titan's strategy?
Titan has a strategy???
Basically, as long as the procedure is done in the office of a REMS certified doctor, anyone can perform the procedure, but they can't go to a surgeon to do it.
the FDA's comments are what nowak488 is referring to. they were absolutely ridiculous.
I'm soooo confused after that REMS presentation!