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DewDiligence

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DewDiligence

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Re: NP1986 post# 142551

Thursday, 05/24/2012 5:45:17 PM

Thursday, May 24, 2012 5:45:17 PM

Post# of 257262
To enable a single global FoB program for Herceptin, PFE would like to show that there is no difference of consequence between Herceptin made in Europe and Herceptin made in the US.

One of the points of contention between drugmakers and regulators has been the requirement in the current FoB guidelines that the reference drug for an FoB be locally sourced. This issue was prominently addressed at the FDA public hearing on FoB’s last week (#msg-75552370); it is, IMO, one of the areas in which changes to the guidelines are likely.

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

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