Cytodyn Inc (CYDY)

[Bill_ENG]

Since it was a "Rolling BLA" I read that and it looks like he was requesting some movement. In other words he wanted modules submitted which would show progress.

Even now they are hurrying in my opinion.

The CMC portion which they have " chosen Samsung " does not make sense to me. They might be screwing up right there. You don't just choose who will be manufacturing your drug and submit their data

They have to show that the drug used in the trials and the drug they are able to manufacture are identical. This means the original plant gets inspected by the FDA and all that manufacturers data gets included in the CMC.

I was in another stock that spent a year on the CMC portion concentrating on 2 manufacturers who would be making the drug commercially after approval, drug batches were produced and tested for accuracy in manufacturing all was supposedly done. Rolling BLA and multiple meetings. At PDUFA time they received a CRL because the original factory in Canada failed inspection.

We will see what happens.

Jmo