The problem is what if 248 people don't die in the trial. Something should be clear when a trial goes on so long without reaching a certain number of events, people are clearly living longer. I would think that a deep dive into the data after half the total patients in the trial were in it for 3 years or more would reveal enough to consider an early approval. If you don't believe 3 years is enough, try 4, even 5, the trial would have been over some time ago.
I agree that the FDA lifted its own hold, but there is no indication that the FDA initiated the hold. The first indication there was a hold was the EMA website and it lists the Germans as the relevant regulator even though the MHRA was also a regulator, clearly indicating it was the Germans.
The rules in the US for a global trial like this is that if a hold is issued overseas, the FDA will then also issue a hold. And it wasn’t a “hold”, it was a partial halt.
The only reason the FDA could lift the hold, because it was not likely the initiating entity, was for the trial to no longer be enrolling any further patients, which is what the lift says.
Remember, this is not just a primary source, dated at the time of the halt, it is updated by the relevant regulator.
It was partially halted in 2015, not long after the Germans certified it for the Hospital Exemption and therefore did a very thorough review of the trial. Unfortunately, the site does not say it was a partial halt or that only placebo patients thereafter were excluded. There is no explanation ATL, which is why all of us over years have used the art of deduction to determine what may have happened. But the FDA is not going to act arbitrarily like this, tell a party to have placebo and then not, but leave it unexplained. That’s not their style, particularly when they insisted on having a placebo. If it was a lock on approval, yes, there is a procedure for that. And the standard of care for the FDA is the standard of care, and therefore by definition to them, not unethical unless there is proof of efficacy, which supposedly for them requires a placebo arm. So that kind of a halt would be arbitrary and likely the subject of litigation. The Germans on the other hand, because of their history, do not like unnecessary human experimentation. I believe having just reviewed the trial enough to give a Hospital Exemption, it would appear to be unnecessary cruelty, to the Germans, to continue delaying access to the drug to the placebo patients when they can see no harm and that patients who get the drug are living longer. I think different regulators have different views on these things and that led to this odd situation.
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