Cyrus Arman at near 12:00: With regard to the c

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With regard to the clinical hold, we believe we now have the required data from Amarex to address the FDA's concerns. However, as we previously seen hinted in last quarterly call, the data from Amarex is not covered in the industry standard format. While this barrier has extended our desired response Timelines to FDA, it has recently been mitigated by actions from leadership, and I am pleased to announce, that during the month of September, the first of a series of docs are in line for submission to the FDA, and we continue to move as quickly as possible on the remaining items.

It is important to note, that substantially all of the data requested by the FDA that lifts the clinical hold, are items that Amarex was contracted by CytoDyn to prepare, but failed to do so. As a result, CytoDyn has taken on all of these responsibilities internally over the last 6 months.

Along these lines, we have also recently completed the warning letter close out process with the office of prescription drug promotion and we look forward to continue to improve our relationship with the FDA at all levels.

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