RE: RE: Vital signsCS...I will add to your last statement a very likely/almost given "positive" point (relating to the safety of Urocidin vs mitomycin C) to hopefully help cheer up a poor investor. And, hopefully the "copy & paste" works...
Your statement:
"Outside history repeating itself, just keep repeating 19%, 19% and it'll make you feel better.......with a 25% overall and 40% papillary, we're in excellent shape"....
Additional point:
From the current clinical trial:
The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC.
Found on page 15 and 16 of Taylor Collison's initial report dated Feb4-11:
Examining Clinical Evidence of Mitomycin C in Refractory BCG
...we have examined the clinical landscape for data pertaining to mitomycin C use in refractory BCG.
In a recent 120 patient Phase 3 study (Feb 2010) BCG-refractory patients were randomised to either mitomycin C or gemcitabine, comprising both an induction course and maintenance course if they exhibited a complete response. The study showed gemcitabine had superior efficacy and safety versus mitomycin C in the randomised patients. The incidence of adverse events was 39% for gemcitabine and 72.2% for mitomycin C. Urocidin™ studies to date suggest a much lower rate of adverse events. On this basis of this study, gemcitabine may actually be superior to mitomycin C, suggesting Endo have picked the right comparator, as mitomycin C is used widely in urology circles.
Finally...what Urocidin's Phase 3a safety data revealed (as you recall but a positive reminder):
"Safety and tolerability data also appears solid, with only 2 serious adverse events (SAE) representing a rate of 1.6%, possibly related to treatment" Source: Taylor Collison, Mar24-11 report
How will Urocidin likely score relative to it's secondary endpoint objective for trial 3b???....
It'll be like shooting into an empty net from inside the blue line!
rg