> GTCB founding costs… 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?<
I’ll search GTC’s old SEC filings for revenue collected from such clients as ELN (for the production Tysabri founder goats). Revenue from companies that accounted for more than 10% of GTC’s total revenue in any fiscal year are delineated in the 10K reports.
>…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.<
Making the switch after preclinical development should be no big deal, but switching after clinical trials have begun would in general not be allowed without essentially redoing the trials. The general philosophy will almost certainly be that a transgenically-produced protein is a different drug than the same protein produced in a bioreactor.