to all DNDN holders:
Here is an extract from a Real Money article today about cancer-vaccine maker Antigenics (AGEN). My question is that while I'm aware that DNDN professes to have confidence in it's proprietary process, could it be so fussy as to cause either serious expense or FDA/manufacturing issues ???
"Many companies began developing vaccines in the early-to-mid 1990s using cells collected from cancer patients. These patient-specific or autologous cell-based vaccines were less costly to develop and had shorter development lead times. Antigenics produces its Oncophage vaccine by harvesting tumor cells from the patient and then shipping the cells to Antigenics' facility. Using the company's proprietary process, Antigenics isolates the heat shock protein gp96 and its associated peptides. After extraction, purification and sterilization via filtration, the autologous product is put in a vial, frozen and return-shipped for administration by injection to the patient.
On Sept. 2, 2003, a clinical hold was placed on Antigenics' phase III clinical trials of Oncophage in both renal cell carcinoma and metastatic melanoma. The hold was placed because of inadequate data to support specifications for product purity, identity, potency and pH, or the degree of acidity or alkalinity of a solution.
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)."
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