Friday, January 06, 2017 11:32:21 AM
From news release:
VBL has also received FDA approval for adjustments in the GLOBE protocol. These major modifications relate to the triggers for the interim and final analyses. The SPA covering GLOBE remains in place. Originally, the interim analysis in GLOBE was to be conducted after 91 deaths. The modified protocol specifies that it will be conducted after 105 deaths, and after 50% of the patients have more than 12 months potential follow up, whichever occurs later. The final analysis will be conducted at 189 deaths (75% of events), versus the original planned for 151 deaths (60% of events).
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Since first patient dosed was in August 2015, it took approximately 17 months for full enrollment. Midway point of enrollment timing wise was around May 2016 ... so 12 month survival for approximately 50% of the population (assuming it corresponds with timing) is around May 2017.
Expecting midyear news ... the later the better.
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