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JPG77

08/29/21 7:39 AM

#181339 RE: 3X Charm #181324

Actually, quite the opposite. An RTF letter gives specific detail as to what needs to be corrected to successfully resubmit the BLA. And Rechnor and team have been working very closely with the FDA as we continue to meet our BLA resubmittal dates. Anything else is pure speculation.

The BLA RTF increases the odds of not getting approval for HIV.