News Focus
News Focus
Replies to #86120 on Biotech Values
icon url

DewDiligence

11/10/09 10:18 PM

#86122 RE: jbog #86120

I've seen situations of changing a $5000 mixer in a bioreactor cost millions of dollars and a couple of years.

True; however, Copaxone isn’t a biologic, so one would think that changes to the delivery mechanism filed under an sNDA ought not to be as problematic for the FDA as changes to a protein drug.