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Posted On: 09/01/2020 4:42:26 PM
Post# of 155807
Thanks Latane (& blafarm).
I assume if you email him in advance of the call and ask him to address it in his remarks when discussing the BLA, he may do that specifically, so you wouldn't need to worry about getting through on the call.
To be clear, the debate is regarding whether or not the BLA acceptance date clock of 74 days carries forward from the initial BLA submission date or resets to the BLA resubmission date? In the Zogenix example, it was reset, but it would be great if it doesn't reset for CYDY given, as you stated, the BLA only had a minor issue.
The PDUFA would still be a max of 6 months + 3 month max extension from whatever that BLA acceptance date is, correct? (hopefully it's just 4 months, but Zogenix was 7 --> 4 months plus a later 3 month extension).
I assume if you email him in advance of the call and ask him to address it in his remarks when discussing the BLA, he may do that specifically, so you wouldn't need to worry about getting through on the call.
To be clear, the debate is regarding whether or not the BLA acceptance date clock of 74 days carries forward from the initial BLA submission date or resets to the BLA resubmission date? In the Zogenix example, it was reset, but it would be great if it doesn't reset for CYDY given, as you stated, the BLA only had a minor issue.
The PDUFA would still be a max of 6 months + 3 month max extension from whatever that BLA acceptance date is, correct? (hopefully it's just 4 months, but Zogenix was 7 --> 4 months plus a later 3 month extension).
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