Mi Dendream, you are experienced in the labeling negotiation process so you know final labeling language is the last step in the drug approval process. However there are interim steps during BLA review but even those labeling steps tend to be late review discussions between BLA sponsors and RA's. Are you convinced the BLA has been submitted and is in late review discussions or am I misreading your position? Without a BLA there is no basis for any discussion and I don't think an RA will entertain any promo labeling discussion without a submission. Can you clarify? Thx