This application required exquisite organization, teamwork and perseverance. We submitted about 350 pages of highly scrutinized regulatory documentation. Especially considering that we received only a couple minor requests for updates, this was an impressive effort.

Such a high-quality submission, followed by a similarly high-quality pre-clinical, non-clinical and CMC program, along with high-quality QC, organization, summaries and interpretation of dozens of reports; all accomplished just about a year after we nominated the clinical candidate.

Thank you for your contribution to the successful delivery of this historic company milestone.