RE:RE:RE:Latest Corporate Presentation (Nov 27,2024). Well, seems I'm going to have to disagree with CancerSlayer, as I'm inclined to think that this most recent presentation (11/27/24) is more likely an attempt to better represent of how the FDA might have advised them to present the information in a BTD application. Which, if that's the case, shows (on page 21) the 12 and 24 month Duration of Response for Keytruda at 18.8% and 9.4%, and for Adstiladrin at 23.5% and 18.4%. Comparing that to Ruvidar (on page 22), the KM Curve estimates that at 53% and 35.8%.
Furthermore, given that the last news release stated that they were going to resumbit a pre-BTD before the end of the year, it sounds to me like that last advice they received from the FDA was concerned more with how they were presenting the data more than it is adding something else to it. And if that's the case... and if this presentation does somehow better represent how the FDA wants it presented (I suppose this is probably a good question to ask in the upcoming conference call)... then does this mean they are also ready to resubmit a pre-BTD?
Maybe I'm missing something, but it has me wondering...