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Posted On: 08/31/2020 4:51:06 PM
Post# of 153908
What September 4th means -- it's not an FDA decision
blafarm is right: Cytodyn does not have to have something done for the FDA by September 4th, and the FDA is not giving a definitive answer or decision of any kind. The date is just the deadline for the FDA telling Cytodyn what they will need to RESUBMIT the BLA.
Now maybe they already told Cytodyn what info is needed; it's even possible, but not at all likely, that Cytodyn has already resubmitted. But more likely the events are:
Sept. 4, FDA tells Cydy what is needed for resubmission (why didnt they tell us this before?);
a couple weeks later, CYDY resubmits;
and then the FDA gives us a PDUFA date, telling us when they will respond by. So please don't expect some kind of answer by Friday.
blafarm is right: Cytodyn does not have to have something done for the FDA by September 4th, and the FDA is not giving a definitive answer or decision of any kind. The date is just the deadline for the FDA telling Cytodyn what they will need to RESUBMIT the BLA.
Now maybe they already told Cytodyn what info is needed; it's even possible, but not at all likely, that Cytodyn has already resubmitted. But more likely the events are:
Sept. 4, FDA tells Cydy what is needed for resubmission (why didnt they tell us this before?);
a couple weeks later, CYDY resubmits;
and then the FDA gives us a PDUFA date, telling us when they will respond by. So please don't expect some kind of answer by Friday.
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