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Terra Biological Pivots To Pre-IND Trials After FDA Spoils Medical Food Labeling

This article was originally published in The Rose Sheet

Executive Summary

FDA warning letter "was a complete surprise to us, especially as we had been advising FDA of our marketing of the CRONaxal product, in writing, for approximately three years as part of our 'orphan drug designation' for glial tumors requirement," says Terra Biological CEO Alan Cook. The firm received an orphan drug designation for oxaloacetate as a treatment for gliomas in 2012.

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