Confirmatory trials, page-14

For me - opacity is a bad sign.

Well - my read is that either Starpharma have been aiming at the wrong goal-posts, or the FDA have suddenly moved them. Why can't they tell us what the Clinical Data needs to confirm? Then we can evaluate this news properly.

So with a cynical view, due to the opaque nature of the release, I translate this announcement as saying the following:

We have not been approved.
We did not confirm efficacy to the FDA's satisfaction.
We might be able to generate something from existing data that will get us approved.

All IMO