Biotech Values

[AlpineBV_Miller]

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.