falciparum were cultured in cRPMI with a range of concentrations of compounds (up to 50M) for 72h
While one study did show statistical significance, the FDA said in a Complete Response Letter that it was insufficient on its own [to provide] substantial evidence of effectiveness. The FDA also noted that the NDA submission lacked data on concomitant antipsychotic administration, did not include data that established that the change in negative symptoms was clinically meaningful and that the submitted safety database had an inadequate number of subjects exposed to roluperidone at the proposed dose of 64 mg for at least 12 months
But the True Cost Analysis score of 45/100 doesnt lie
The most detailed population-level analysis comes from Wharton et al., published in Diabetes, Obesity and Metabolism in 2021, which pooled data from the STEP 13 trials
Bioinformatics 22:808814 Sharma H, Taneja M, Upadhyay SK (2020) Identification, characterization and expression profiling of cation-proton antiporter superfamily in Triticum aestivum L
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