Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our [application] by the Food and Drug Administration. The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the [application] in approvable form. |
Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our [application] by the Food and Drug Administration. The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the [application] in approvable form. |
We respect the thoroughness of the FDA review process and are pleased with this decision. |
We respect the thoroughness of the FDA review process and are pleased with this decision. |