Tuesday, May 16, 2017 1:39:09 PM
1) Dror clarified the interim date to late Q3 and said it's driven by the 12-month follow up on half of the patients. That date is in Q3 and since it takes a few weeks to analyze the data, the announcement will be in late Q3. But he also said that the events were occurring to what they expected.
2) Confirmed ph3 ovarian in 2H17. FDA offered a SPA but company declined. Already picked CRO and will provide more info later. Like rGBM, not doing European countries. More color: "We already had a discussion with agency in December of 2016, and we already got the green light on the protocol and the green light of doing a Phase III where the endpoint is survival; so all of this has been done. What we will have in second half of ’17 is actually start recruiting patients."
3) Confirmed launch study of combo with a PDL-1 blocker in lung cancer by EOY17 .. and later said that first trial will be after the data in 1Q18
4) Confirmed presenting new data at ASCO "that VB-111 in destroyable tumor regression and attenuation of tumor growth in recurrent GBM using individual Phase II patient data". This data may explain the driver behind the increase in OS.
5) Confirmed new production facility will be operational 4Q17
6) Said DSMC focussed primarily on safety but also factored in efficacy
7) Not doing ph3 for thyroid but said that if VB-111 is on the market and thyroid patients need the drug then it could be available for them without a need to do a full ph3 for thyroid. Nice to cross that bridge when that happens.
Personally, I see the company making positive progress. The next 3-5 months will be significant.
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