Biofrontera received official review of its drug approval dossier for BF-200 ALA
Biofrontera announces that the European Medical Agency (EMA) has sent the official summaries and preliminary questions of the reviewers (rapporteurs) about the approval dossier of its leading drug candidate BF-200 ALA for actinic keratosis. The reviews will now be distributed to all member states of the EU. Major objections were neither raised in the preclinical nor the clinical part of the dossier. Contingent on satisfactory answers to the questions raised, the rapporteur recommended the drug approval.
According to the current understanding of Biofrontera management, the reviews are in line with the current temporal and financial planning. Thus, market introduction is still expected for the fall of 2011.
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