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Replies to #90097 on Biotech Values
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AlpineBV_Miller

02/03/10 11:00 PM

#90109 RE: turtlepower #90097

I think worries about passing manufacturing are not in the drama queen bear category. I think you're flat out wrong, but there are many more moving parts than the typical biologic. Since manufacturing was a significant part of our first three meetings with the company, we've had a decade to become familiar and comfortable with it.

The CMC issues were minor (documentation, equipment barcodes missing) and would not have held up approval.