Biotech Values

[jq1234]

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.

You don't know whether most of those 1/4th of patients have T315I mutation. One thing he did say was true that 1st qtr CP/AP/BP breakdown wasn't going to impact revenue because initial treatment durations weren't going to be much different among CP/AP/BP. Its impact would be clearer over time.

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.

My expectaton is lot lower than yours. I am still concerned about dosing. If you had read FDA medical review, dosing reduction and interruption were much higher among CP than AP/BP patients. Sprycel originally had 140mg/day dosing for all patients, but they did a separate study that allowed them to lower dose to 100mg/day for CP patients. I am also not comfortable with FDA grouping pona safety similar to VEGFR class of drugs which are really not for chronic use rather than other drugs in the same class. Because of these concerns, EPIC trial becomes much bigger binary event, thus post marketing safety data in CP patients are important now to get a better reading.