Patrick Gallagher | Source | Chair, Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory group...

When they made it an option not to submit it to FDA, that’s an option nearly everyone took. That’s the cautionary tale for the therapeutics and the vaccine for FDA and regulators around the world to make sure they’re making the process as efficient as possible but still making sure they’re getting enough data to be sure they’re comfortable and confident.