For newbies1 Dec 2019 12:03
We are very pleased to receive this IND approval from the FDA, marking another milestone in the developmet of Clevegen. This approval will allow us to expand MATINS into the US using the same protocol both in Europe and in the US, accelerating our understanding of this novel precision medicine in cancer patients who are refractory to all other treatment options and streamlining the regulatory processes. With the US IND now approved, in due course, we plan to file applications for Breakthrough status in the US and Prime status in Europe, further facilitating regulatory interactions during the development of Clevegen."