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CytoDyn, Inc.

CytoDyn Responds to FDA as High Court Rules Agency Cannot Guarantee Drug Safety

Published in AIDS Weekly, March 23rd, 2009

CytoDyn, Inc. (Pink Sheets:CYDY) has sent the FDA what the Company believes is a complete response to the agency’s preliminary comments on Cytolin®, a monoclonal antibody designed to restore immune function in those afflicted with HIV/AIDS.

As one example of how this process works, the FDA asked CytoDyn to conduct a laboratory experiment to quantify the effect of Cytolin® on HIV. In its response, the Company explained that an immune modulator cannot have a direct effect on a virus making what the FDA requested a scientific impossibility. Rather, the reduction in HIV levels consistently observed in patients treated with Cytolin® is due to improved functioning of the...

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