Ian Wendt: Yes. The CA1 or conditional approval designation that you see for Canalevia right now is an easier pathway to approval. You have to show a reasonable expectation of effectiveness and doesn’t require necessarily a full effect of this trial that you might — in the designated population that you might see for traditional approval. So it allows you to get to market faster and for less cost but it does come with some limitations. And a couple of them, just so you understand what those might be. are that it cannot be used off label. So there’s a federal law in place that for CA1 designated medications, prescription medications, they have to strictly adhere to the label as indicated. And you might be aware that the veterinary community, they write off-label medications all the time and human health physicians do as well.
But in this case, for CA1, there is that limitation. There’s also a limitation in the size of the market. So right now, you can only seek this for — in the canine arena for indications that would dose no more than 70,000 dogs. So there are some limitations there. And then it comes to some requirements to complete the full effectiveness trial for traditional approval within a 5-year time frame of your initial approval. So we’re working on that. And ultimately, we will end up — we anticipate having full approval in the future. We’re working with the CVM on that clinical development program. But we are seeing great uptake of Canalevia-CA1 especially among better oncologists which are our primary target audiences. We engage with them in a variety of ways.
In fact, I’m of in a couple of weeks at the Veterinary Cancer Society Meeting. We will have a chance to further educate an important customer group on the benefits of Canalevia-CA1.
Lisa Conte: Thanks, Ian. Okay. We have time for one more question here. We’re coming up on the which we’re trying to keep this to an hour. Does it which I assume is talking about Crofelemer, also work on IBS? So there are so many potential indications that reference to a pipeline within a product. There is published Phase II data for IBS, irritable bowel syndrome, with Crofelemer and we couldn’t do everything. So there are target pipeline indications of Crohn’s disease, inflammatory bowel disease. There are investigator-initiated trials going on right now in functional diarrhea in IBS as well. Of course, we have short bowel syndrome in CDD. So there are other indications, other important patient populations to go after in the future which is a very risk-mitigated future drug development strategy for this company because, again, it would be indications if it’s Mytesi where we already have the safety, we have the chronic safety, we have the manufacturing, how can we continue to expand the label, how can we continue to expand the population that in the health care providers that Ian can educate and promote to and grow the revenue even further.
And of course, the patients that can benefit even further. But right now, we are very focused can’t say it enough on cancer therapy-related diarrhea, short bowel syndrome and MVID and other indications and other territories in the future. So with that, I know there’s some other questions there. I can’t get to all of them and some of them we’ve already referred to, again, the sentiment behind the question and the comments that we’ve made. Thank you all very much for listening. Thank you very much for your support for Crofelemer, Mytesi, Jaguar, Napo, Napo Therapeutics, we’re going to get back to work here. It’s going to be a very, very important year for all the stakeholders and we’re really looking forward to what will be uncovered in the next 6, 7, 8, 9 months of this company.
Thank you. I’ll conclude now.
Operator: Thank you. This will conclude today’s webcast. You may disconnect at this time and thank you for your participation.
