below is the question and the answer by Dr. Dror related to the ovarian phs 3 trial and the SPA offered by the FDA if VBLT want to apply for it:
Charles Duncan
I wanted to ask you about the ovarian cancer trial, you'd mentioned I believe in the press release that you may able to enter Phase III here soon. And I'm kind of wondering what are your remaining steps that are necessary before you can articulate the protocol and the start of that trial, seems like it's been in the works for a while?
Dror Harats
So we are quite advanced in this trial; although, the plan when we say the second half, was it's going to be toward the end of the second half. That was the plan from the beginning and that's the days that we all should remember. We already have the protocol ready. We went back and forth with FDA and our biocertification. We actually have been offered by the FDA that if we would like we can ask for an SPA, the decision is not to do that, but actually to agree with FDA on many details and that's what we were doing.
We already picked CRO, but I don't want to elaborate more on that at this point. But in due time we will tell you who we are going through the study with. We are already picking centers both in Israel and in United States, and I want to explain important things on where we are doing our trials right now, and what is our exit plan when we are discussing Europe? There’re quite a differences between the U.S. rules and the European rules regarding therapy and regarding the way the facility that you are producing the drug for Phase III should be. If it should be already fully commercialized and inspected then you can do a Phase III trial with the biologic like VB-111 in Europe.
So right now we are not including European countries in our trial. It doesn’t mean that we are not talking to the European authorities, because if a drug is prolonging survival in indication when there is a major need, the European authorities will actually take a very serious look even if the study hasn’t been done in Europe. So the idea is to do the study of the ovarian mainly again in the U.S. and in Israel. We already looking at different sites, we’re preparing the compounds, the production. I think that we’re already done with that, and all the details to make this study successful study.