DaubersUP....I think the BD is for sure on B for OM, and it is by management design to maximize the value of the pipeline for the shareholders. I believe it is a vote of confidence by management on P trial meeting its end points with very nice statistical significance. And the company being able to save more of the P franchise for latter in the approval process. I think the company is very serious about being able to move forward on P under the 505[B][2] pathway for approval.
I am very excited about the B franchise but there is one problem that could lessen the potential of the drug, but that problem does not come into play,imo, in the OM designation. Notice i did not say the problem is impossible to solve. And of course, B will in all likelihood get the BTD designation from the FDA which will lead to reduced time to approval.
All the above JMO!