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Biotech / Medical : Biotech Valuation
CRSP 63.99+4.7%Oct 31 9:30 AM EDT
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To: kenhott who wrote (32867)11/11/2009 11:04:24 AM
From: Biomaven1 Recommendation   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
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