RE:RE:RE:RE:Is this the year?
My reading of the approval process lines up with Eoganacht. Yes, seems slow to us but I'm guessing underfunded agency with laborious procedures.
Some things that may give hope around approvals in the future (2022 vs 2023....)
- ongoing BCG shortage might move treatments into a slighly faster review category (who knows)
- bladder instilled therapy are not the same degree of systemic worry as a drug given by mouth or IV. Some drugs in that category cause more complicated adverse reactions which need to be clarified by having a lot of patient's treated. For example if a drug affect the QT interval in the heart that can be a biggie. If you find one QT prolongation in 10 patients is that 10% or do you need to see another 90 patients to realize that the adverse reaction is a one off or 1% event. Bladder drugs don't have that degree of systemic concern.
- this drug is not a biologic. Biologics have major challenges with proper production facilities. Need complex inspections of facilities to ensure that the protein will be made properly. Non biologics are slightly easier as far as I read.
- if it goes well and the optimized drug and optimized procedure has a high RR then one could imagine it being elligible for review sooner as may not have to have as large a sample size to determine true population response. For example if you have 100 patients with a 66% RR, then a statistician would extrapolate a true RR that ranges from 55% to 75% (crudely). If you had 20 patients with a RR of 66% then the true range would be 45 to 85%. 45% is underwhelming. I'm not a statistician but it comes down to margin of error.
So, as always, more patients, a decent RR......success.
I don't see a buyout happening anytime soon. This strikes me as a scenario where you hope to generate cash by selling rights ahead of time to a part of the world. Lose out on some future income but gain near term cash. That or share offering :(
My hope is a gap up that makes me happy to wait for another while.
IMO.