It was intimated Covid ARDS indication would be a game changer. It was intimated the Novartis deal was around the corner (even immediately before the announcement of them pulling out).
It was strongly intimated that this most recent submission would be successful.
The CLBP announcement was released as a success, not even mentioning that they failed to meet the primary endpoint.
We don't know the details of the studies - we don't know how many subgroups they trawled through before finding significance. This is why people that actually understand stats don't buy it.
Though many here eat up what the company says.
I'm not explicitly stating foul play, or any sort of bird themed play either as you suggest.
But the company has a strong history of over promising and under delivering. They've got a strong history of representing results in very skewed ways, so one has to really dig into the details to discover the failures.
These methods will fool those who don't understand, or don't do their dd. But the FDA won't be fooled easily.
And that's not a bad thing.
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