I don't think there was ever " Agreement " that two trials would...

I don't think there was ever " Agreement " that two trials would be required. The FDA would have suggested that two trials, given the size and scope of the first one, could be sufficient to go for approval given the totality of the data - probably since MSB did not want or have the cash to run a 10,000 person trial for CHF.

The issue is that, what if the first trial was a complete success in the primary end point. Nil people re-hospitalized, plenty of deaths, even no change in mortality...

Or say the first trial involved 100,000 people.

No need for a second trial.


The confounding part here is, that the secondary endpoint is even more important than the primary end point, and had large statistical significance.... Failed trials usually don't have benefit, so for this trial to miraculously show the benefit that it did..... the odds would be quite staggering, like winning lotto. Maybe a statistician could figure it out.

Now the FDA have asked for and been presented with the complete dataset for the treatment group that would give the "most benefit to the public" with respect to 3 point mace outcome. What kind of a request is that in between two phase three trials. Given the company has not applied for approval, and was slated to run another trial.... why are the FDA asking for this information.

There is probably a rational answer. They are considering the evidence in it's totality from the single trial, hence why they asked for the dataset that provided" the greatest public benefit" Surely they are weighing up public benefit to the treatments, and will decide if Accelerated Approval is needed, if they want to save people today.... or wait 10 years for the next trial results, and hundreds of thousands will perish.

I'm positioning to make another purchase....... need to make the most of the share markets' insanity pricing.