RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsFrom the AUGUST 2023 Earnings Call - Patrick Trucchio asked about
Accelerated Approval for Panc.
Patrick Trucchio
Thanks. Good morning, and congrats on all the progress. I guess, just a couple of questions from me. The first is, can you talk a little bit about the pace of enrollment in the Precision Promise program and specifically, how much influence will you have on the conduct of this program, and how is it expected to accelerate the registrational pathway for pelareorep?
And then, secondly, also regarding this program, what would you expect to be necessary to lead to an accelerated approval pathway in pancreatic, and when might you have that first data cut from the program?
Thomas Heineman
Sure. So, the -- yeah, so the benefits of working with Precision Promise, well, there are several benefits in addition to the cost considerations. One of the benefits is that the Precision Promise protocol is already a well established study that has been vetted by and discussed at length with the FDA. And so, we have already a very solid -- we know that we're entering a study with a very solid clinical program, very solid clinical pathway.
The study is already working with well-established and in fact, many of the best academic sites in the U.S. so that we have a whole access to a large number of pancreatic cancer experts. And they're all very experienced, not only in pancreatic cancer, but in -- with this particular study. And so, there is a very solid group of partners with whom we'll be working right away, which will not only enhance the enrollment, but also provide us with individuals with whom we can work, who can help us make sure that everything is going smoothly with the study and deal with any issues that might arise during the study.
And from a regulatory perspective, as I said, this study was developed and discussed already with the FDA. And so, if everything goes smoothly and we come out the other end with the anticipated positive results, then there should be a clear path towards a BLA submission directly from the results of this study without having to do additional studies subsequently. So that's some of the benefits of working with them.
In addition to the operational benefits, which of working with sites, as I said, who are very experienced already since this study is up and running, we do not -- we can save time because we will not have to do things like initiate sites and get everyone familiar with the protocol. So, I think that there are obvious operational efficiencies in addition to the regulatory benefits and the access to the strong experts in the field.
As you can read all too well, Professor Heineken avoided talking about an accelerated approval whatsoever. Accelerated Approval is granted BEFORE you run your clinical trial... and Heineken's answer clearly shows that they would be running a classic phase III, albeit with two endpoints, PFS and OS.
So PLEASE for the love of Jehovah, STOP with the hocus pocus about Accelerated Approval already