Replies to post #25968 on Cytodyn Inc (CYDY)

[trding]

management must be aware of the gravity of delays due only to CMC

Yes, I'm sure they are now. The FDA played a big role here with the now delay by changing required the safety numbers up to 300 and then back down to 150.

Last year, when the changed the safety data to 300 for the combo trial, that became a critical piece to completing combo. It looks that management planned on having the 300 safety data enrolled in July, which would give them the 6 months to complete the CMC while waiting on the required safety data, i.e. no delays waiting on the CMC.

If the FDA had said 150 safety is all that was needed last year, they probably would have enrolled the 150 and put the other resources on completing the CMC.