In the prior trial design/protocol, did the SSR fall between the 1st & 2nd IA?
Could the current trial design/protocol include a NEW SSR, perhaps also somewhere between the 2 IA's?
If the patients are not eventing fast enough to have a reasonable expectation to get to 248 Events by end-2015, could a new SSR evaluation cause another increase in Enrollment (to try to get to the required 248 events)?
(It is unlikely that 248 Events & 348 Enrollment will coincidentally both occur on the exact same day. One will trigger before the other. Both need to occur before the trial can complete, correct?).