2 ms·
“the FDA set a worrisome new precedent by allowing Janssen to use a “withdrawal” study as its second “positive” study. These studies tend to be slanted in favou
by jacobush 7y ago
“the FDA set a worrisome new precedent by allowing Janssen to use a “withdrawal” study as its second “positive” study. These studies tend to be slanted in favour of the test drug because they only consist of patients who responded well to the drug in the short-term trials. For this reason, they have never previously been deemed adequate in satisfying FDA requirements.”
Sounds pretty damning