They addressed the issues and risk factors are there to address things that could go wrong. So of course they lay it on there, that’s what the entire section is there for, so that investors have been warned about things that do go wrong, like when regulators reject an application. That is a possibility with all of these companies. They had some extra steps to fix it, but all according to guidance and regulations and previous to unblinding so NOT post hoc and therefore not manipulated though post hoc reviews do get approved as well, but this is not that case.
Policies changed, regulators allowed things they had not done before. These things plus taking to using a real measure of survival, actual survival, rather than a surrogate or proxy measure of survival, that’s even better. It takes longer, which is why no one uses it. It was also always the secondary measure. Now it is primary and the trial is better for it.
As for the ECA, they’ve done an incredible job, the regulators almost seemingly changed that policy with this trial in mind, if one reads between the lines. Very few of the longs or doctors or other experts that I have seen express themselves are losing sleep over the ECA, which is not even from this trial and is an external data point which the regulators are reforming to accept.
Now maybe you’re against the trends of regulatory reform, but it had the blessing of Congress and a Presidential signature, and it’s the law. In the UK, and EU, likewise, laws are changed. Your posts are inconsistent with the times and not particularly up-to-date in terms of thought or trends with these trials.
Having said that we all know the stated risk factors and accept those as always possible results. But constantly pointing at them and telling everyone they will happen is kind of a newbie, non-investor kind of a thing. People who don’t accept any risk, should not be in any stocks, and certainly not biotechs.
Market Data 
Markets 
AI
