Biotech Values

[Aiming4]

GTCB: would the EMEA really be able to accurately say that this current iteration of questions will be the last needed in order for approval?

I would think it possible that the answers provided by GTCB could still generate new questions.

Maybe that's included as part of the "IF answered satisfactorily" part of the equation?

Also does GTCB work with the EMEA interactively on the answers, or does GTCB have to ask all their clarification questions up front, then craft their response without further input from the EMEA?... Aiming4.