Cytodyn Inc (CYDY)

[gestalt2]

I am just wondering how this all came about with the FDA wanting a face to face meeting. I don't think they just felt like changing the # of patients out of the blue. Possibly, prior to enrollment both CYDY and the FDA agreed on the qualifications for the 30 patients without really knowing if the actual population for pro 140 treatment match those qualifications. The difficulty in finding the 30 patients might show that they saw a large # of applicants being turned away due to some criteria they don't meet for the trial. It could be that the FDA saw that it would be better to loosen the criteria to include these patients to get better data that reflects the patient profile that would be prescribed pro 140 once approved for use. It is possible that CYDY has a list of applicants that are ready to get injected today to fill the extra 10 spots. The extra safety requirement is baffling to me given there has been no indication of any safety issues in the past. However it sort of does not matter because they needed to recruit 300 for the mono anyway. I look forward to the investors call next week for clarification.