VaxGen gets cure notice from HHS regarding anthrax vacc

California, USA-based biopharmaceutical firm VaxGen says it has received a written cure notice from the Department of Health and Human service following the Food and Drug Administration's issuance of a clinical hold notification, delaying the second Phase II trial of the anthrax vaccine candidate rPA102. The agency explained that data the company had submitted to date were insufficient to determine the product's stability for clinical assessment. The HHS indicated that the clinical hold ruling may endanger VaxGen's ability to complete the contract, worth $877.5 million under the BioShield defense program (Marketletters passim) and, as a result, said that "unless this condition is cured within 10 days after the receipt of this notice [November 3], the government may terminate [the contract] for default under the terms and conditions." VaxGen said it is working to prepare a written response.