Dear FOP community,
This year, 2019, is the year that Clementia expects to file the first-ever application to seek FDA regulatory approval for a potential treatment for FOP. After 6 challenging and wonderful years, it is a dream come true to be able to write these words. We thank you for your trust and support.
We could not have made it to this point, so quickly, without the efforts of Clementia’s team of 53 employees, our clinical trial investigators and their teams, and a supporting cast of consultants and subcontractors from around the world. In total, over a hundred people worldwide have happily worked thousands of hours toward bringing this potential treatment forward, and our work is not yet complete. To achieve all of this, hundreds of millions of dollars have been invested thus far. Furthermore, Clementia will continue to make substantial investments in order to complete our regulatory filings and ongoing clinical trials, and to create a global organization that will be able to make palovarotene, once approved, available to those in need.
Today, everyone at Clementia is laser-focused on submitting a new drug application in the US in the second half of 2019, and we are also exploring the best way to achieve approval for palovarotene, an investigational therapy, in Europe and around the world. We would like to thank the regulators around the world for their collaborative approach while evaluating palovarotene and our programs.
As we grow from a clinical development company to a fully integrated and self-sustaining commercial enterprise, we wish to reiterate our commitment to you. Clementia’s investment in the FOP community will not end with the submission of our NDA or, should we receive approval, market launch. We will continue to evaluate promising drugs or future technologies that could lead to new breakthroughs that may further improve patient outcomes. We promise to continue to work with your best interests in mind, and for the benefit of our team members and all of our stakeholders.
All the best to you and your families,