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Posted On: 07/15/2020 11:22:21 AM
Post# of 158220
Re: Goosebumps #43082
No the BLA review is on hold until it is resubmitted.
A class A meeting, which the Cytodyn PR says they will request, with the FDA to discuss what needs to be corrected will happen within 30 days of receipt of the meeting request.
Then a resubmission will be acted on by the FDA within either 2 months or 6 months of receipt of the resubmission, depending on the deficiencies outlined in the RTF.
So it's adding months to the decision process.
A class A meeting, which the Cytodyn PR says they will request, with the FDA to discuss what needs to be corrected will happen within 30 days of receipt of the meeting request.
Then a resubmission will be acted on by the FDA within either 2 months or 6 months of receipt of the resubmission, depending on the deficiencies outlined in the RTF.
So it's adding months to the decision process.
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