Cytodyn Inc (CYDY)

[Bill_ENG]

The idea is not to want the BLA submitted quicker or even on time.

The goal should be to get it submitted properly and having a CMC specialist to guide that aspect is key.

Once submitted there is a lag for FDA acceptance of the BLA, usually a few months. Then they will issue a PDUFA date 6 to 8 months down the road. A failure there gets you another year before getting another shot at it. That's 1 and 1/2 years to 2 years blown.

Hiring this guy to go over the CMC is a good solid move to get it right.

A lot of the CRLs issued by the FDA lately have been aimed at the CMC sections so having an industry veteran at this is a smart move by NP.

Jmo