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hoffmann6383

04/17/22 7:16 PM

#460330 RE: MI Dendream #460329

well said mid! I'm hopeful as well

Survivor2012

04/17/22 7:30 PM

#460332 RE: MI Dendream #460329

Thanks MI -- great narrative -- one of your best yet -- you are peaking at the exact right time!!

dmb2

04/18/22 7:02 AM

#460366 RE: MI Dendream #460329

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

GLTA