Thursday, December 18, 2014 6:24:31 PM
But one interesting thing I found when looking at Sorafenib's pivotal phase 3 trial results was that it used 600 patients and was stopped at the 2nd interim analysis in an indication that has a survival expectation similar to 2nd line NSCLC and the endpoint was also overall survival.
So you could use it as a guide for when the 2nd interim analysis in SUNRISE might be expected.
Clinicaltrials.gov showed the Bayer phase 3 trial as first received on March 14, 2005. The trial was fully enrolled based on the history of changes by April 2006. Bayer issued a PR about the 2nd interim analysis achieving its endpoint on February 12, 2007.
http://pharma.bayer.com/scripts/pages/en/news_room/news_room/news_room14.php
That made 23 months from first received by clinicaltrials.gov to 2nd interim analysis stoppage and roughly a year after the trial was completely enrolled.
So if PPHM can enroll as fast as Bayer, we can expect a second interim analysis for SUNRISE sometime around early December 2015.
If PPHM enrolls based on their estimate of December 2015, we can expect the 2nd interim analysis around November 2016 IMO.
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