Molecular Biosystems regulatory update

Based on the letter and subsequent phone conversations with the FDA, MB said it does not believe that the questions threaten Albunex's approval. MB said it was encouraged by the relative emphasis in the letter on product labelling and post-marketing activities.

The majority of the letter was focused on revisions and questions regarding labelling, post-market surveillance protocol, and post-market surveillance study submissions. The FDA also asked for clarification or amplification of information in MB's PMA amendment filed earlier this year; as well as for information on two studies not involved in the PMA. ...