(Total Views: 691)
Posted On: 01/29/2022 6:50:50 PM
Post# of 153986
posted by cindylou822 re amarex/cydy key part bottom paragraph
"Nothing in there about study data. Just the regulatory file and an audit. Sponsor's normally help prepare a CRO for an FDA audit. Amarex can't keep the FDA away and if they don't let Cytodyn help them prepare, then Cytodyn's response to any findings is that they attempted to help prepare the CRO for an audit but were not allowed in.
Amarex has been charging regularly for the GvHD study which Cytodyn had put on the back burner and just updated to terminated due to nolack of enrollment on the clinical trials website. Amarex had no reason to charge against it for 2 years"
"Nothing in there about study data. Just the regulatory file and an audit. Sponsor's normally help prepare a CRO for an FDA audit. Amarex can't keep the FDA away and if they don't let Cytodyn help them prepare, then Cytodyn's response to any findings is that they attempted to help prepare the CRO for an audit but were not allowed in.
Amarex has been charging regularly for the GvHD study which Cytodyn had put on the back burner and just updated to terminated due to nolack of enrollment on the clinical trials website. Amarex had no reason to charge against it for 2 years"
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