3 ms·
I mean once you have the data it shouldn't be exactly rocket science to check if the trial was done well. Given how clear the data is as far as one has heard un
by hannob 6y ago
I mean once you have the data it shouldn't be exactly rocket science to check if the trial was done well. Given how clear the data is as far as one has heard until now the decision should be a no-brainer. You already had the trial protocol since several months, so that could've been checked in advance.
I'm actually rather wondering what's taking the EU so long.
- boyband6666 6y agoIt is not a trivial process, and these are ferrociously complex. Safety, Quality and Efficacy - each are hard to check. From how people are categorised in trials, how missing data rules are implemented, to how it is manufactured and the stability data. It doesn't take a year for no good reason. Yes this has been sped up massively, but steps have been abbreviated - let's not kid ourselves. If interested, the FDA release all documentation - search for Drugs@FDA and find a recent medicine, and see just how much review it gets. You'll be surprised!