This was interesting because Lumateperone met their endpoint in 2 of 3 trials:
“The FDA gave Janssen quite a bit of flexibility,” says Todd Gould, a neuropharmacologist at the University of Maryland School of Medicine. “They only met their primary outcome in one of three acute studies.”
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If you mean Lumateperone, the FDA hasn’t approved or disapproved yet. They will decide by the end of Dec.
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I’m looking forward more to iti007 than min101. But I dont think insurance will cover it for a while. I imagine it will be too expensive. I have my doubts that iti007 will be approved because of a delusion or dream of mine. I have a delusion I took min101 in a past life and I had some anxiety or restlessness but I barely remember.