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Friday, August 08, 2014 3:23:57 PM
That being said, there's no reason to no longer think a BLA is currently being assembled and possibly submitted (rolling review) for Accelerated Approval based on that first interim's data. However, when the trial may officially conclude (if not at the point at which Accelerated Approval is granted) is now anybody's guess. If AA is not granted at some point (anywhere from this fall to next spring, possibly summer if there is some drag or further requests for additional data by FDA/EMA) and the trial is continued to its primary endpoint's new conclusion of 248 events (assuming that is correct info--it may not be), that would put the primary completion date out somewhere around late summer 2016. Second interim of 199 events may be around winter 2015.
The two big clues imo are the interim efficacy data recommendation not being delivered to the Sponsor and the sample size increase, indicative of lower event rates. To me that spells a BLA is currently being filed for AA. And so this increase of events required to conclude the trial may not matter, as the trial concludes once AA is granted.
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