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Re: Biowatch post# 133579

Thursday, 12/22/2011 10:45:59 AM

Thursday, December 22, 2011 10:45:59 AM

Post# of 257579

Without biosimilar approval framework, patent exp. dates meaningless in many cases.

I do not understand what you mean. Companies are already inking FoB partnerships and have been meeting with the FDA to get guidance on FoB clinical-trial designs. The guidance documents that the FDA eventually publishes will codify and possibly expand on what the FDA is already telling companies during these meetings.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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