Replies to post #200218 on Avid Bioservices Inc (CDMO)

[Protector]

hayward, no he thought so but mix up Average and Median.

With a 6.5 MOS on 10 patients of which data is more or less available that is actually an excellent score. 32 patient results must be added. The list is then ordered and the middle value is the MOS, not the sum divided by 38 because that is the average.

Both are totally different.

[EYEBUYSTOX]

I'm saying even if the MOS for bavi+sorafenib is 10 months it won't mean anything because it's an open label study at one location without a comparator arm and without a partner there's no chance the company will advance the indication anyway.

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.