Replies to post #923 on Vascular Biogenics Ltd (VBLT)

[wcopeland]

- Now you have me worried david! This is the culmination of much waiting, so very stressful but VBLT should be just fine. But you are right, postponing everything else until AFTER a positive interim makes things a bit more scary.

- I think we will figure out why they shunned the SPA once we can actually look at their trial design. Like I said earlier, I think it had to do with the design of cohorts. But it could also be something like interim requirements. I do not think they would shun FDA just to skim on biomarker collection. And Dror mentioned that they are still using survival as endpoint, so that obviously was not the reason.

- I cannot wait for the VB111+PDL1 combo in lung. My guess is they are partnering with AstraZeneca. That is where Humphrey used to be. Plus AZ is looking for a way to fast-track Imfinzi.

- NASH. Whatever happened to that news about a NASH partnership?!? That would really get VBLT a nice cash reserve and much needed insurance.

- ASCO patient history. It is interesting. They may have found a biomarker that tracks with prognosis/response? Or maybe they can just show that a subset of patients who are "long-term responders" have some common trajectory? I guess we can find out when the abstracts are released.

[Valueinvestor12]

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.

[gr8db8]

davidal66 ... since the company has been through a SPA with rgbm, I think they know the pros and cons about doing it. I suspect they have more confidence in the ovarian results and therefore, need less assurances from the FDA. Not doing a SPA also cuts down on time and costs.

This site sums it up well:
"However, the SPA process can often take several rounds of FDA review before agreement is reached and the FDA may require a more robust trial design than what would have otherwise been considered adequate, which could result in unnecessary delays and increased costs. As with all aspects of drug development, a sponsor should carefully weigh their priorities before entering into an SPA agreement with the FDA."
http://camargopharma.com/2017/04/special-protocol-assessment-important-drug-development-program/