Biotech Values

[DewDiligence]

>>Although Antigenics responded on Oct. 22, 2003, and the FDA lifted the hold on Nov. 24, 2003, the company is still waiting for the FDA's response to the validation package for the qualified potency assays that was submitted during 2004. Assay validation is used to establish the robustness and reproducibility of the assays and to demonstrate that the potency assays work consistently under various conditions. This is part of the FDA's standard requirements for acceptance of manufacturing under good manufacturing practices (GMP)."

DNDN should have an easier time than AGEN with its product-characterization assays because, unlike AGEN’s Oncophage, the antigen component of Provenge is the same for all patients.