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BTH

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Alias Born 06/11/2010

BTH

Re: mcbio post# 115139

Friday, 02/18/2011 9:01:24 PM

Friday, February 18, 2011 9:01:24 PM

Post# of 252501

I think there's a chance that any negative rida news



Do you really see there being no overall survival benefit with regard to Rida considering the p-value of .0001; I'm thinking the arms have got to be nicely separating at this point. Further, even a 3 week PFS, there's got to be some subsets (I am thinking in the soft tissue subset) which show a tremendous PFS benefit (I don't think bone sarcoma is going to show much at all). Also, didn't Tarceva show only a few week (or somewhere around there) PFS benefit and they were approved?

It irritates me that Merck hasn't said anything about the results, but, I just do not think they wouldn't at least file an NDA after spending all this time and money on the trial - what do they have to lose. The drug certainly was statistically significant and met its SPA endpoints.

Personally, I think there is too much "reading into" going on with regard to Merck not saying anything and that is having an unfounded effect on the stock right now.

Ponatinib is the driver though...no doubt about that. The only thing that scares the hell out of me is some ridiculous outlier QT-prolongation or some negative event, not event related to the drug, that could happen in a seriously sick person, which would cause the trial to be halted...even though it likely had nothing to do with the drug. In fact, stuff like that irks me to death in any trial (most recently, Oncothyreon's Stimuvax which was halted because 1 out of 1,500 patients developed encephalitis and after 1,500 patients had been taking the drug for years.... so the FDA halted the program for three months and killed the stock)

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