ITMN: Do you think if telaprevir is approved 191 will have to go head to head vs them? Can't give you a good answer but here are a couple thoughts. 1-I don't think telaprevir will have BID dosing at least not on initial approval. 2-I think either Roche will push the dose up with a higher efficacy rate or keep it low and get a better safety/tolerability profile either way I think the goal is for better SVR on ITT basis. Whether they do a large enough trial to power that I don't have a good feel at this stage. 3-I have no factual basis to think this but I suspect we get a slightly different twist in Phase 3. A while back on an InterMune call they were asked about coformulation not just with a polymerase which may be much further out but with CoPegus (Ribavirin in general). They did not answer and I am not a science guy to know if it is feasible but if so it could give them a nice edge. This is just one possibility I think there may be something such as this not necessarily this.
For what its worth baring setbacks I think we will start Phase 3 before telaprevir is approved given the time to put the package together, file it and then get the response back from the FDA.
Could add a lot of time, cost and risk to pivotal studies. Roche pays 2/3 and also InterMune has an option to opt out of co-development in return for a higher royalty worldwide then what they get x-US (not disclosed what higher rate would be). I think a lot of what InterMune does may be predicated on what happens in January '09 (Pirfenidone). If successful raising funds will be a lot cheaper. As you and others have pointed out there is a decent possibility InterMune is not a standalone company sometime after this. I think even if Pirfenidone fails that may be true (assuming 191 is still moving forward) obviously the price is much lower in this case. The valuation becomes much simpler either way. If Pirfenidone succeeds I'ld like InterMune to stay independent but with Warburg on the board I am not sure how likely that is.
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