RE:Is this the year?My guess is we'll have definitive 360 day results for the first 25 patients by August 2022 and can apply for BTD and accelerated approval then. Since we have fast track status we should get the FDA response in 6 months - by January or February 2023. If nothing else works, FDA approval to commercialize should move the needle.
"Assuming that this phase II is positive, and eradicates this disease in a significant proportion of patients, then there is a pretty clear route to arriving at regulatory approval. We recently had a guidance from the FDA which very clearly states the type of patient we need to treat, and the endpoints, which are, that their cancer is effectively eradicated and that is sustained for a period of a year."
Dr. Michael Jewett, July 2018 valueman1 wrote: Many of us, myself included, are long time shareholders. Honestly can't say how long I've been invested in a position but at least 19 years. Many many false starts. Could this be a year of conclusive proof and numerous news releases to show us all what we believe to be a real cure for bladder ( et al) cancer. Anxious to see what unfolds