Biotechnology and Pharmaceutical Investor Research
Complete Response letters

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What is a Complete Response letter?

The FDA (Food and Drug Administration) issues a complete response letter when it wishes to communicate to a company that an application to market a drug (NDA, new drug application) will not be approved in its present form. It also indicates that the review of the application by the FDA has been completed.

For investors in biotechnology companies, clearly at best this is a much less favorable decision than an actual approval of the drug. Complete Response letters do not imply that a drug is approvable (as in the old Approvable letters) if certain conditions are met. However, sometimes an application can be amended and resubmitted and have a chance of approval.

Complete Response letters are not made public by the FDA, and the text of the contents are not usually made public by their recipients either. The fact that a letter has been issued is announced, and corporate spokespersons are free to reveal what they wish about the contents of the letters to investors.

For more information see the FDA Complete Response Letter Rule page.