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Cosmid may have talked me into a starter position in this, if for no other reason than to watch the story unfold (that, and, well, we've hit on some many other biotechs in the last 2 years I've lost count- I think we're on 7? 8?), but single arm trials that require a paradigm change amongst clinicians scare me a bit.

Another option for you Fuma, is to watch me suffer while my position in URGN is underwater ;-)

I'm not worried about single arm study for URGN. It is simply repackaged mitomycin C that is in a novel matrix that forms a gel at body temperature while a fluid at room temp. Sort of counter-intuitive, but it works. Currenly, mitoC is delivered by instillation into the bladder, held for a fixed period of time, and then emptied via cath. The gel is "painted" onto the tumor and remains in place on the bladder or ureter wall until the drug is delivered over days rather than hours. Instillation of MitoC doesn't work for the renal pelvis and you don't want reflux into the kidney itself. Access to the renal pelvis is very limited by transurethral instruments, so if approved, this would allow painting the tumor via transurethral approach and avoiding neprhrectomy. So single arm doesn't bother me because there are years of history behind use of MitoC instillation. Also, it is hard for me to imagine that prior FDA meetings did not address this given it has received breakthrough designation. The folks I talk to don't like doing neprhectomy in the first place for low-grade cancers. Right now, it is a necessary evil, and the paradigm doesn't change that much.

I also don't think that SGENs drug overlaps at all with URGN approach. One is for local, the other distant disease. I think URGN will have a PDUFA date long before SGEN finishes P3.

Cosmid (long URGN)
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