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Friday, September 01, 2017 3:04:19 PM
"In December 16th and April 17th and recommended it continues as planned. The final DSMC review should take place soon as we are close to reaching the point of at least 105 mortality events and 12 months follow-up on 50% of the patient. Giving the fast recruitment rate of the GLOBE study and the current proximity to the end of the trial, we have agreed with FDA under the SPA that this interim DSMC review will not require formal futility analysis and we expect the DSMC recommendation in late-September 2017. Top-line data after the occurrence of 189 events are expected in early ’18 based in interaction with FDA. And given our SPA agreement, the VB-111 GLOBE study should be the only trial we need for BLA and approval."
https://seekingalpha.com/article/4098686-vascular-biogenics-vblt-ceo-dror-harats-q2-2017-results-earnings-call-transcript
"because that’s the last patient being was actually in December, but that’s only couple of patients. Most patients were actually recruited even before November."
https://seekingalpha.com/article/4098686-vascular-biogenics-vblt-ceo-dror-harats-q2-2017-results-earnings-call-transcript?page=4
So, is the thinking that in the latter months the events would significantly increase.
About 128 patients with Avastin only. With about 90% patients the 32 weeks would be around March 2018.
Based some of the information above, including the FACT that we have not reached 105 deaths as of Aug 14 (around because not sure what the cut of the data was.) we are looking good? This also means that top line won't be out until closer to mid 2018. I'm not sure with information given, how the CEO continues state that top line will be early 2018.
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