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Re: flipper44 post# 71953

Thursday, 09/01/2016 8:52:03 PM

Thursday, September 01, 2016 8:52:03 PM

Post# of 701705
From Grant Zeng report:

Even with the screening delay, we still anticipate that the Phase III trial will reach its first interim analysis for efficacy in mid-2016 and anticipates that the Phase III trial will reach its primary endpoint PFS
(progression free survival) in late 2016.
According to this schedule, we expect an NDA will be submitted in 2017 and DCVax-L will be approved in 2018.



What is also odd .... if Zeng still anticipates the first interim to be reached in mid-2016 (I agree with you ... seems like this milestone would have been reached a long time ago) .... then this would indicate that merely 60% of the events would have been reached.
This would then also make it likely it would still take a substantial amount of time before the SECOND interim (at 80% of events) would be reached.
And then again ... another lengthy period of time before the full 100% of events would be reached.
Thus it does not make sense to me that Zeng anticipates that "the Phase III trial will reach its primary endpoint PFS in late 2016."
Seems to me this would then take much, much longer.
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