Otto1776: “Although we expect to submit B…”

Tue, 17 Aug 2021 16:48:41 +0000

Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, and other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications. (pg 26)