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
Confirmatory trials, page-14
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