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biomaven0

12/09/13 6:43 PM

#170987 RE: binchey #170977

>>all this favorable data

We don't in fact have that much new relevant data - the key for the FDA is what the event rate is in 3rd-line patients. The dose analysis should help.

I really can't predict what the FDA timing will be. I still expect the drug will be back on the market with a narrower label and a REMS of some sort.

Peter