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RockRat

08/17/16 11:46 AM

#203559 RE: ghmm #203549

RE: ITEK,

Thanks, the R&D day stuff is still there, but I hadn't slogged through it (looked at the more recent presentation). Luckily, one can search the slides. While the slide you show appears to be monotherapy (could be just poorly labeled; numbers seems to match combo numbers), the PGA combos show the same relative performance. Since the AE profile of trabodenoson roughly matched placebo, but gave some efficacy, I could see trabodenoson winning easily in the marketplace but for cost versus generics alternatives. This was my investment thesis (also a contrarian trade on the announcement of recent financing), but these slides make the tradeoff even murkier.

Since glaucoma is bad for QOL but not life threatening, I can understand the FDA's stance in a way. But one wonders how Timolol got approved for this in the first place. Standards lower in 1978, perhaps, because of fewer options (for example, PGAs not available for almost 3 decades after)? Also, tolerance appears to develop over time, maybe not captured in the timeframes of the trials versus trabodenoson. How important are the extra 2mmHg offered by Timolol versus the risks?

For ITEK, in sum: nearly as good efficacy, better safety, higher cost. HMMM.

Speaking on behalf of myself and others, thanks to all for the help/conversation about this one.

Regards, RockRat