<<<The best course of action for Elan, in my opinion, would be to cancel the BAP PIII in carriers (I believe Dew suggested this), keep EDT and spend some of the saved trial money selling Tysabri in Crhon's disease, which is sitting at some dismal number of patients right now.>>>
I have to agree to part of this. I do not understand the continuing effort to test carriers for Bap. It could be that the marginal cost to test carriers when they are already going to be running trials for non-carriers is not that great so what the heck. We don't have those numbers.
But strictly from the Phase II results, either Bap worked tremendously well for non-carriers, or there was a lot of selection bias or ad hoc foolery going on. It makes sense to me to do a trial for non-carriers, focus on the hopeful tremendous results. get the drug to market, and sell to 40-60% of the marketplace.
It could even be better than this as Bap may have some valuable prophylactic applications for carriers and non-carriers alike at earlier stages of the disease. I believe that ELN-005 is going to be tested with bio-markers on this basis.
As for pushing tysabri in Crohns, i am a bit leary. The efficacy in crohns is outstanding. No dispute there. The problem is, and please correct me if I'm wrong, that the moderate to severe crohns patient tends to have a background of steroid use and of using immune modulating treatments. All such items that are associated with an increased risk of PML. If the incidence of PML in MS is 1 in 4,000, 1 in 10,000, whatever it is, but less than 1 in 1000 by some good number it would seem, I would think that the incidence when used in crohns would be much higher. Much more careful scrutiny is needed. I like the MM indication much better.
Tinker
AI
