RE:RE:Breakthrough Status after Ph1I would just point out that a requirement for entry into this trial was that 1, the patient was unwilling to have their bladder removed or 2, the patient was incapable of with standing the surgery. Probably the latter in these first 3. So they were all looking at a death sentence in the next year or two. After all, someone quoted RW as saying these 3 were the worst of the worst. glta.
vestor111 wrote:
2b7 - great find. Things could unfold very quickly because stepping back and trying to be as objective as possible, why wouldn't TLT be granted breakthrough if 9 for 9 with minimal (or no) complications is achieved?
Especially when you consider it is one hour, non-surgerical out-patient procedure that has cleaned-up an agressive and recurring cancer in the first three patients (so far) with very minimal side-effects (that basically have cleared up on their own) - vs a very high likelihood that all three would have had their bladder's removed. (And that BTW is the 30% Dr K stated would be a success for NMIBC.)
So if the BSMB recommends moving to phase 2 (The 90 day c-scopes are exploratory) - next month maybe... With Breakthrough Status in the following weeks? Especially aided by the 180 day results of the first three patients in mid-Oct.
I wonder when the med team recommends pursuing Breakthrough? They probably would like to see the 90 days results... so say... mid-December and Mr Smith goes to Washington (probably after conferring with HC of course...)?
Gee I wonder what would happen then? Maybe some of the board vermine move their bashing "skills" to another stock??? Forget the share price - just getting rid of them would be worth it! LOL!