Rhonda: So I do remember that at least with...there's been a couple of studies that you were involved on with water fasting, you showed a combination with standard of care treatment, it seemed to be safe, and also to some degree you seemed to sensitize some of the cancer cells to death, and also maybe even protect some of the normal cells and some of these blood cells. They weren't getting neutropenia or the myelotoxicity quite as significant as people that didn't do the fast.

Do you have any...Now, I know you've published studies on the fasting-mimicking diet in animals and cancer, in combination with standard of care. Is there any clinical trials that you're planning on doing with fasting-mimicking diet on humans?

Valter: Yeah. No, we're doing it, right. So, we're going a little bit slower than predicted, in part because we didn't see coming the food aversion. So patients, when you give them any food with something that is toxic, they develop a food aversion. So, anything that you give them with a toxicity, is now recognized as toxic also.

And so now we're having to develop a number of new foods specifically to avoid the repetition. You cannot repeat anything twice essentially for...So if somebody has eight cycles of chemotherapy, you know, we may have to give him eight different things, all respecting the formulation requirements. So, yeah, that surprised us little bit. But we already, couple hundred patients have already been involved in these multiple randomized clinical trials.

And then the good news is that there is no problems, we don't see any problems with the fasting-mimicking diet in cancer treatment, but it's been slower than expected because of these, you know, A, because of course you cannot promise, you cannot go to a patient and say, oh, this is going to make you feel better. And if you give them a pill, it's much easier because there is no effort on the part of the patient.

With the fasting-mimicking diet, if you knew it was going to be much better for you and somebody told you, I don't think it would be a problem because we see it with a healthy subject. But if you don't know you have cancer, and then you have this food aversion, altogether, it makes it very tough for people.

So we had about a 40% thus far compliance, and so now we need to tweak it so we get to maybe 70%.

Rhonda: Yeah, it sounds like a challenge. But if there are oncologists right now that are interested in using the fasting-mimicking diet in combination with their standard of care treatment, that is something that they can do. Correct?

Valter: Well, yeah. The way we've been putting it is that they can, if the patient cannot wait for the end of the clinical trials, and the oncologist agrees, you know, for whatever reason that they cannot wait, then they can certainly do it with the standard of care. So they do a standard of care, and then the fasting-mimicking diet along with that.

Now, the FDA prohibits any product or any claim related to disease prevention or treatment for something that has not been FDA-approved. So then, you know, I think an oncologist should be very careful in presenting it to the patient. So it has to be presented as something experimental, that could be good for them or could be bad for them. So that said, of course in mice we have incredible results, we and many labs now have repeated this, so works very, very well.

And so, you know, if somebody cannot wait, I think then it's fair to go to an oncologist and say, "Obviously, I'm running out of options. Shall we consider this one?"

Rhonda: What does it take to for...how many like clinical trials does it take for FDA to approve something? Is it...

Valter: No, the FDA is a specific process. So you have to enter, you have to file, it's an IND application, and there is...it's a very expensive and long process, and it's not just trial. So, it's three phases, phase one, two, three, and in the end you probably have between 500 and 1,000 people, 1,000 patients, and then they make a decision based on the data, whether it's approved or not. The whole process usually costs about $50 million. And so, you know, this is what makes it complicated, right? Because, yeah, it's not easy to justify this kind of investment on a diet, you know?