Thursday, September 21, 2017 1:22:09 AM
Also, this trial has changed several times based on extenuating circumstances. I do not think anything happening makes perfect sense to anyone, except oren... and now apparently you.
Clearly rapid enrollment impacted the cancelled interim, however, I am not convinced that is the end of the story. Remember, these guys spent a good deal of time with FDA at end of last year hammering out modifications to interim. In Dec16/Jan17 they adjusted plans due to increased enrollment, so why were they surprised by their projections a second time in August?
Also, you brought up good points about timing of enrollment. If mOS has truly been reached, then a look at the interim data would be very telling of the primary endpoint (OS).
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