Replies to post #3810 on Talon Therapeutics Inc (fka TLON)

[BioRecruiter]

I dont thing the delay was labeling but I know for a fact the FDA didnt request any additional info from the trial.

[goodwill4all]

I stand corrected on Peds - not part of Aug. PDUFA date.

On labeling negotiations - My question is why did Talon dose first patient post May PDUFA extension and why is the confirmatory study powered for superiority?

Trust me, any drug company with a pending drug under FDA review & pre-approval cannot give specifics. Labeling negotiations is even more that I think is appropriate, but no one besides the FDA & Talon knows what that means. Coould be dose related, indications, post marketing...