Hi Mozzarc,
I'd be pretty surprised if this didn't get FDA fast track approval, especially if they can get the Pentagon on board. The FDA fast tracks any number of new and sometimes quite scary anti-cancer drugs, so not sure why they wouldn't fast track something as safe as PPS. But who knows...?
2.5% of the arthritis market in 3 - 4 years? Ambitious perhaps, but not overly so imo.
If I were PAR, I'd be looking at developing well-funded social media strategy, and enlisting everyone with painful OA that I could reach as an advocate for PPS.
More of a threat I would think would be an Indian generic, even without FDA approval, as US citizens can freely import prescription drugs for own use, even if it's technically not strictly legal. This is why I've been so conservative with my pricing estimates.
Also, not sure how Bene would ramp up production. Elmiron is a pretty niche product (only about 500 prescriptions in Australia last year). Are they going to build a new production facility (ies) or what?
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