Junkyarddag:
DSCO management is a reactive player, Winners are proactive and need to lead and not follow,
The FDA is allways going to have additional questions and DSCO's board should have learned that lesson after the last letter.
It is time dsco's management probe the clinical data they have and look for questions that will arise...and complete the filling..
Risk is a builtin factor with all drugs and probing the other area's of systemic risk needs to be part of their plan and guidance direction.
How you project and plan your response in learning risk/reward outcomes is critical in gaining trust..
Neodoc has my trust as well as some others on this board, it is no different in working with the FDA.