...........................
Kevin Dede ( H. C. Wainwright & Co.): "Can you talk, Shawn, a little bit about the financial side? How's your balance sheet look? How do you think you'll be able to fund a pivotal trial? It's no small undertaking."
Shawn Shirazi: "In August of 2019 the company raised 17 1/4 million to fund the phase 2 clinical trial. And we're well positioned to continue with the completing of the phase 2 non-muscle-invasive bladder cancer trial."
Kevin Dede ( H. C. Wainwright & Co.): "How about the development for gbm and non-small-cell lung cancer?"
Shawn Shirazi: "Those are still in very early stages. We don't forsee to do phase 1 of either one of those before Fall of 2021. By then we'll see how much money we have. I believe we should be able to fund them but you never know. With Covid we had a setback of 9 months with treating and enrolling patients. So we're still managing. We managed, adjusting a bit with the resources within the company to help us to continue having no issues with funding the new studies that we need to."
Kevin Dede ( H. C. Wainwright & Co.): "So when would you expect to have relevant market data back from the P2 next year? What other process would you have to go through for full FDA approval and then what's your commercialization plan?
Shawn Shirazi. "This is a phase 2 pivotal study. We're looking at 15 months in an ideal case. The patient is treated on Day 1. Hopefully within 3 months we see a complete response. This is the "at any point complete response" that's required. Then the patient has to be followed up for another 12 months from that date because the secondary endpoint we have agreed to with the FDA is 12 months post initial complete response. So that adds another 12 months for a total 15 months before we can complete. Then going through statistical analysis and everything. Now the nice thing is, because we have gotten fast track designation we can communicate with the FDA on a regular basis with the data we have received on the patients. So at any point that we have sufficient data and the FDA agrees that we can proceed with an accelerated approval application we will go ahead with that. And then it all depends on the FDA, and their review and the dataset they have in front of them - that's where we will hopefully be getting our approval to go to market. So roughly 2 years."