Texas Biotech's data snafu

Small biotechnology companies without the resources to develop internal capabilities across the entire spectrum of drug development often turn to contract research organizations to conduct and analyze clinical trials. However, companies still need the in-house expertise to direct and evaluate a CRO's work.

The experience of Texas Biotechnology Corp. illustrates the pitfalls. Last week, TXB announced that the review deadline for its NDA for Novastan argatroban thrombin inhibitor to treat heparin-induced thrombocytopenia (HIT) was set back six months due to corrections to patient end point coding information that had been submitted to the FDA...