InvestorsHub Logo
Followers 0
Posts 167
Boards Moderated 0
Alias Born 03/28/2005

Re: poorgradstudent post# 570

Thursday, 08/10/2006 12:18:02 PM

Thursday, August 10, 2006 12:18:02 PM

Post# of 12660
PGS - ? on safety data

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.

Join the InvestorsHub Community

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.