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News Focus
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Couch

12/27/15 5:16 PM

#246846 RE: PPHMVERYLONG #246844

Yeah what happened to enrolling enough patients to secure first and second look ins. Oh yeah that's right - already happened. Next

On the development front, I’m pleased to report today that we are nearing completion of enrollment in the cornerstone of our bavituximab development strategy, our Phase III SUNRISE trial. In fact, with over 90% of the expected enrollment complete, we currently have sufficient patient enrollment based on the assumptions of the study to allow the trial’s planned interim evaluations and final readout based on the primary endpoint of overall survival. Having said that, we do expect to complete enrollment of at least the pre-specified 582 patients over the coming weeks.
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md1225

12/27/15 5:36 PM

#246847 RE: PPHMVERYLONG #246844

It will be on time with OVER the 582 patients.
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hopefilled2014

12/27/15 8:35 PM

#246860 RE: PPHMVERYLONG #246844

What happened to full enrollment by the end of the year?

Well, its Dec 27, sooooo.
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Protector

12/28/15 6:40 AM

#246869 RE: PPHMVERYLONG #246844

PPHMVL, the same as PPHM's start of SUNRISE clinical trial before year end in 2013.

Everybody asked the questions that you are asking now about end of enrolment of that trial. At the time it was more like: What happened to starting a PIII for 2nd ln NSCLC before year end.

They started it the last day of the year.

End of enrolment of SUNRISE is due in 3 days, to be PR'd in JAN I assume.
On last Q/CC was announced that we have all needed patients enrolled and that the remaining once would be enrolled the coming weeks.

Actually, no one except PPHM is interested in those remaining ones. The RISK was not to be able to enrol the NEEDED once (per FDA agreement). So even if the end of year holidays push them into enrolling a few more patients in JAN nobody cares any more. It will have no impact on 1st and 2nd look-in either because those 33% and 50% events can come out of the patients enrolled since JAN 2014.