Thanks - very interesting info.
That also shows why FDA insists on some large trials - not to just believe in what companies say or the very small trials (wink wink 32 patients).
"Fortunately, at the time, there was an FDA official, Frances Oldham Kelsey, who did not rely on information from the company. She single-handedly prevented thalidomide use in the US, even though FDA regulations were not as strict then. "