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Posted On: 10/02/2022 9:24:22 AM
Post# of 148903
So, I think the internal audit is the one that Recknor, CRO for Pharmacovigilance, the VPs and the prior FDA regulators are doing together.
I think the external audit is the one that Cyrus brought in to validate the work of the internal audit.
2 audits over the same data for the BLA should make the FDAs job much easier and should hasten HIV approval.
If that's all Amarex will have in damages, they would be ill advised not to pay.
I think the external audit is the one that Cyrus brought in to validate the work of the internal audit.
2 audits over the same data for the BLA should make the FDAs job much easier and should hasten HIV approval.
If that's all Amarex will have in damages, they would be ill advised not to pay.
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