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Re: None

Wednesday, 06/28/2006 10:17:02 AM

Wednesday, June 28, 2006 10:17:02 AM

Post# of 257257
GTCB founding costs. My apologies if I missed this in the FAQ. Does anyone know the approximate cost for creation of a founding herd by GTCB, for company ABC who wishes to evaluate the platform in support of clinical trials, for example? Does $250k sound about right?

The issue I am thinking about is, if protein used to support clinical or preclinical work was produced in a bioreactor, will FDA/EMEA allow the switch to Goat production? Will new data demonstrating equivalency generally be required? In other words, does a company need to adopt GTCB very early in the process, or would they be able to make the switch say, after the completion of a preclinical, a phase 1, or a phase 2 trial.

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