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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