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Re: poorgradstudent post# 159315

Thursday, 04/04/2013 5:42:04 PM

Thursday, April 04, 2013 5:42:04 PM

Post# of 252797

He also said something stupid about thrombosis and said there has been none. And then later said AEs are consistent with the label. It's just dumb to attach the word none or any similar word when talking about AEs, no matter how benign.


It seemed pretty clear to me throughout the call that he was saying there was no signal of anything different in terms of AEs from commercial patients vs. PACE patients. I am not convinced that this is an undisciplined or dumb way of stating things.

That being said, I am overall neutral on the call. I don't think it was meandering: Berger gave his prepared remarks for a couple of minutes, which were pretty to-the-point and linear, and then opened the floor to a slew of analyst questions. The analyst questions were much more 'all over the place' of course, but I think this is true of just about any analyst Q&A.

On the other hand, I think I agree that without the hard numbers, I am struggling to understand the real value of this call. Superficially, the stock had a small bounce-back today, but not sure how much of that can be attributed directly to the call. I do think there was some interesting new data that he disclosed; particularly that 1/4th of patients so far are second-line. I think that is a fairly good sign. And honestly, I think when you look at there having been 325 patients, not including the starter sample program patients, that appears to be a pretty strong uptake for the first quarter.

Overall, I think there were some good things and some bad things, and in the end, my outlook isn't really affected by the call. I still think Iclusig sales will meet or beat consensus, and I would be highly surprised if the EPIC trial did not meet the primary endpoint at the interim analysis. I suppose the question about tolerability in the frontline setting is an open question that only data will answer, but if I had to guess, I would guess that it will likely be on par with the 2G TKIs - relatively safe with some 'unique' AEs that make it less suitable for some patients with certain risk factors.
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