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Re: vidpok45 post# 16850

Wednesday, 02/29/2012 8:53:15 AM

Wednesday, February 29, 2012 8:53:15 AM

Post# of 80490

Has 113 been tested long enough in humans to reveal any potential for the issues that now have required the label modification for xalkori?



In a word - no.
It is too soon to know if the liver toxicity is drug specific or class specific.
113 has the potential to deliver a more favorable side effect profile.
As bell mentioned, They haven't seen any significant safety issues so far.

I was finally able to access the call today.

Regarding pona:
They said that their impression from the pona meeting with the FDA was the data can really become the basis for approval.

I agree with Harvey's closing remarks.
It was a great call with great questions.
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