(Total Views: 397)
Posted On: 08/28/2019 1:17:01 PM
Post# of 149459
I don't recall a date ever stated for a combo meeting. During some of the interviews NP said they had been in discussion about 525 vs 700 and sounded very confident / optimistic that FDA would accept 525. I have asked IR for clarification and have not received a response. I would think they would PR this once known, but if 525 is acceptable I expect the clinical portion of the BLA to be submitted very soon as NP previously stated Aug/Sep for clinical portion.
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