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pcrutch

03/13/12 6:11 PM

#138625 RE: mcbio #138623

Two questions

1- What % of women at FR++?

2- Curious what imbalances would have specifically caused such different results.

In addition, Endocyte today announced updated overall survival data from the PRECEDENT trial, which show improvement compared to the results announced in December 2011. Overall survival was a secondary endpoint in the PRECEDENT trial, but it was underpowered to demonstrate a definitive result in this endpoint. In particular, the overall survival hazard ratio for the FR(++) patient group was 1.097. Adjusting for prognostic imbalances between the study arms, the adjusted hazard ratio of 0.481 reflects a 52 percent reduction in the risk of death. Overall survival statistics in the intent-to-treat population were also slightly improved compared to those announced in December and those data will be presented at an upcoming medical conference.

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turtlepower

03/13/12 8:41 PM

#138631 RE: mcbio #138623

ECYT - Just finished listening to the call. The EMA appears to have been very receptive and without the updated OS numbers too! So that bodes well and should remove some of the the overhang from the bad OS data in december. A few additional things to note

- The trial will enroll a small number of FR+ patients as well so there is the potential of expanding the label.
- The company is still looking to partner and I think at least in the EU they should.
- They may do a taxol safety study because some ovarian patients are on taxol.

In addition Doxil also causes cardiovascular toxicities after about 12 cycles so EC145 can be used as a stand alone and I think Ron Ellis confirmed that during the Cowen presentation.