RE: RE: Another reason for the PhaseIIIbLorne, Beech got it.
What I mean by "such study" is the head to head comparison of MitomycinC with Urocidin. To get Urocidin to be approved, all it has to do is by proving its efficacy and safety. To date, it has shown a result of 25%DFS and only minor intolerance. By these results alone, it's the best of the breeds and should be approved. Even if FDA requires larger sample group, Endo does not have to include Mitomycin C in the study.
Endo is very confident of the eventual outcome when they changed the protocol for the PhaseIIIb study. As Beech explain, this is a brilliant move. It will prove Urocidin's superiority aginst the only competitor (not owned by them), ensure a dominance in the BC refractory market and at the same time open the posibility for off-label use for first-line treatment.
One more thing, by including Mitomycin C in the study, Endo is also building in an insurance. Although it is very unlikely the 25% DFS will vary too much with a larger sample test, there is still a chance it might drop some. But in this study, it is compared to MitomycinC which already has a lower success rate. So with a larger sample, if Urocidin's rate fall, statically, Mitomycin will likely fall as well. Urocidin will still look good and can still claim its case to be an approval worthy candidate.
I hope i am making sense here.
The marketing phase of Urocidin is about to begin with PhaseIIIb, folks.