How far in advance of NDA/BLA expected approval do (or should) manufacturers begin planning their compendia submission strategy?

During Phase II Trials
% (0 votes)
Initiation of Phase III Trials
% (2 votes)
6 months prior to approval
% (1 votes)
3 months prior to approval
% (0 votes)
At time of approval
% (0 votes)
After approval
% (0 votes)
No strategy
% (0 votes)
Initiation of Phase III Trials
66.67% (2 votes)
6 months prior to approval
33.33% (1 votes)
During Phase II Trials
0% (0 votes)
3 months prior to approval
0% (0 votes)
At time of approval
0% (0 votes)
After approval
0% (0 votes)
No strategy
0% (0 votes)