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Re: dshell post# 98717

Monday, 02/01/2010 3:06:29 PM

Monday, February 01, 2010 3:06:29 PM

Post# of 212212
first my position: Long


can a bio-pharm company apply for fda approval w/o a facility to consistently manufacture the drug? no. part of the fda approval process is demonstrating consistency IN THE MANUFACTURING.

is it the same standard? I dont know.
But it seems to me kfda approval before manufacturing is putting the cart before the horse