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Thursday, November 12, 2015 1:48:00 PM
Perhaps, with good TE event data in early 2016, the FDA will allow less stringent exclusion criteria - presuming all are on Lovenox. Torley indicated this has already happened, to some extent, over the summer. They will also be making the trial international. It will be telling what medical centers, and how many, they have at the start of the trial.
Against:
Halozyme's ph3 trial will pre-select for high HA state - possibly excluding 50-60% of those stageIV pancan screened. To get their 420 subject initial cohort, they may have to screen 1000.
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