(Total Views: 274)
Posted On: 12/03/2019 2:39:48 PM
Post# of 154740
That is not my understanding. I think they have the stability data for 350 mg complete (long ago), but I haven't heard details about 525 mg or 700 mg other than mid-to-late December. I'm guessing they are doing both simultaneously. I believe the previous reference to having 525 mg ready to submit was the clinical portion and not the CMC part of the BLA, but I've been wrong before?
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