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DewDiligence

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DewDiligence

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Re: drbio45 post# 24657

Friday, 02/24/2006 3:59:13 PM

Friday, February 24, 2006 3:59:13 PM

Post# of 257302
>The process isn't approved and the new data and review would be like starting from scratch<

The EMEA cited no deficiencies in the CMC section of the MAA, so the production process is effectively approvable without modification. (The deficiency was in the clinical-data section of the MAA.) This achievement is the culmination of 15 years of work on the technology of protein purification.

There is still much work to be done to get an approved product, but “starting from scratch” is not even close to describing the situation at hand.

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

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