Biotech Values

[jbog]

Dew,

I'd tend to look at Item's 1 & 2 on the 483 for the CRL. That could represent a greater hurdle.

The WCL was blamed for out of spec product. Product that was produced was obtained by a method that isn't part of their procedure..... Can you trust that if produced per procedure it would yield the same results? Not easy questions to answer.