I called Joe today about this specific topic because I recall Rich Purcell discoing this as the most important and last part of the process which once completed quickly leads to the FDA IND final application with expected quick approval. Generex began this arduous process five months ago with no help from BARDA. Listening to Rich again on the CC and today calling Joe really illustrates how science doesn’t listen to feelings and depends upon reliable data.

We know from public comments that the CMC GMP runs will be essentially the secret sauce, as Joe put it earlier to me, that his scientific team presents in their IND filing to the FDA, and will be sent by Generex (they’re the sponsor) to their partners in China. We have been told this important milestone is expected to be completed in late March and everything wrapped up in a bow for the FDA to approve the IND in April.