I would want answers to the following questions in order of priority:
How long (in months) to scrub (if not already begun), to lock, to top line, to release of stat anal, to FDA filing (if results are positive)?
Are you re-analysing the psue-progressions and when will that be completely done?
Have you considered whether Cognate is still a reliable supplier and are you satisfied that the answer is still YES?
When do you expect P2 for direct to start?
When do you expect the combo trials to start?
When will the Black report be ready for release?
Please explain the reason for the hold or why you can not tell us?
Do you expect the US or UK approval track to move more quickly to approval?
Have you turned down any actual partnering deals with BP?
Have you turned down any actual but outs from BP?