Since adverse events can/do develop over time, it makes sense that that data should be periodically monitored. However, from the point of view of reviewing a BLA/NDA for approval, what is the convention for freezing data collection for analysis? Whatever is in front of the reviewers at the time? Endpoints reached? Trial terminated? Etc. Thanks.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.