Lorne, don't forget patent right timelineLorne, yes it's possible but very unlikely thatEndo is dragging its tail so they can maximize their $ from Valstar as you say. Butconsidering the time limitation on the patent righton Urocidin, both Endo and BNC should not want to drag on it. Also don't forgetthere will be other drugs coming on the market to challenge it. Endo would liketo get as much sales as possible during the patent effective period and before other challenging drugs comes into the market.
Like I said in the Valstar/Urocidin post, Urocidin coming on board does not preclude the use of Valstar. Endo actually is in a very good position then. It would possess two out of the three approved drugs for the refractory patients. As a matter of fact, I think they are trying to use the PhaseIIIb to knock out Mitimycin C with a superior direct comparison result by Urocidin.
As far as I can see, the Phase IIIa have yielded results in efficacy and safety good enough for the approval of Urocidin. In the PhaseIIIB study, it is a comparison of a chemotherapeutic and an Immunotherapeutic with totally two different actions and hence intersecting but not mutually inclusive response populations. Using it to gain approval for Urocidin just does not make a whole lot of sense to me. I think the real purpose here is Endo is going for a total dominance with the PhaseIIIb study with the direct comparison to Mitomycin C as a knock out punch.
Perhaps, the FDA wants a bigger sample population with more stringent criteria.