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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: kenhott who wrote (32867)	11/11/2009 8:42:05 AM
From: rkrw	Read Replies (1) \| Respond to of 52153

I don't disagree with you about safety being the major risk and efficacy being nearly a foregone conclusion but i'd point out they're dosing to a DLT and are already above (60mg) likely registration trial doses (15-30mg). Still would be good to have some headroom for patients who need higher doses and also for potential in other indications. <<<Safety is still a real issue as ARIA goes to higher doses and more patients>>

To: kenhott who wrote (32867)	11/11/2009 11:04:24 AM
From: Biomaven	1 Recommendation Respond to of 52153

I agree with most of what you say. But I guess I would go further, and say this "Phase I" trial is really more like a pivotal study than anything else. Efficacy: They have already demonstrated efficacy in patients that were otherwise going to die. That means for me that they have already crossed the efficacy approval bright line. Just how good a drug it is remains to be seen - remember that many of the patients on Geevec etc. can take many months (maybe even a year) to show maximal efficacy. (Then they start to decline at some point, but that's another story). So at this point there is still room for improvement as their data matures. Safety: As you point out, this is for a fatal disease, and as rkrw points out, they are already above the likely dose they will use in registration trials. At some point they will hit some DLT's - all these kinase inhibitors have some off-target effects and at some point those will kick in. But even if some emerge at the current dosing or lower, that's tolerable in a disease like CML. Bottom line is that I believe early signs are that this is a best in class drug in terms of efficacy and hints that the same is true in terms of side effect profile. Peter