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Friday, March 07, 2014 7:17:34 PM
According to clinical trials.gov, the pseudo-progression group is analyzed separately.
When you fully contemplate what that may mean, you will conclude that the p.s. group also needs some basic number of events to occur for statistical analysis. (This would not be a primary endpoint event trigger.)
I could ramble on until I am blue in the face with hypothetical numbers, but I think we may want to consider the fact that the pseudo-progression enrollment probably did not start until 2011 or sometime shortly thereafter.
Think hard about that. Really hard.
Ultimately, we may be waiting on a number of events in a separate group all together (or maybe they just recently reached that number). I do not think that number of events would be very large. Even though the p.s. group is not used for the primary endpoint, it would be really important to have enough powering in this separately analyzed subtype.
That may explain the delay and why efficacy is still under review.
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