Biotech Terminology – Complete Response Letter (CRL):
A Complete Response Letter (CRL) lets the drug sponsor know that their New Drug Application (NDA) has been reviewed and cannot be accepted in its present form. The letter cites specific deficiencies and outlines recommended actions for getting the application prepared for approval.
Complete Response Letters are typically bad news since it means the drug hasn’t been accepted yet, but it’s not necessarily rejected either. The drug sponsors still have an opportunity to correct the shortcomings and resubmit. It’s important to note that CLR’s are not made public by the Food and Drug Administration (FDA), allowing the drug-developing company to disclose as little or as much of the information contained within it as they would like. This can become problematic for traders and investors alike, leaving them to wonder whether or not their investment has lost substantial value once a CRL has been issued.