Regulatory roulette at the FDA. “In context, this looks like the regulatory rules of the game are being changed retroactively.” Moderna ran a 43,000 person Phase 3 trial based on FDA guidance, then got hit with a rare Refusal-to-File letter […]
This is still only the beginning. “Moderna has given out the first doses of an mRNA-based influenza vaccine to participants in an early-phase clinical trial, the company announced Wednesday.” | learn more
By Avak Kahvejian, partner at the incubator behind Moderna: Flagship Pioneering. “This ability to understand, devise, manufacture, test and distribute antidotes and vaccines to a novel virus was due in large part to the development and maturation of bioplatforms.” | learn more
I only recently learned about Flagship Pioneering and I have a small crush on them. They’ve founded over 100 companies, including Moderna (a name you’re hearing often in vaccine context), with 22 IPOs since 2013. Here’s them on plants: “Plants […]