RE:Adult trial failed to meet primary endpoint but was approvedfossi, why not provide your analysis for how the other tests concluded the patients were growth hormone deficient yet macimorelin showed the same patients could produce growth hormone? This is a very interesting result. Are the other tests overdiagnosing growth hormone deficiency and leading to the overtreatment of children with unnessessary drug? Do you support that? Does the industry have a problem? Macimorelin was tested against another test,considered the gold standard(Insulin Tolerance Test), in the adult trial and was approved for adults.
The previous pediatric trial showed "PK/PD profiles are in a range expected from the adult development program".
Macimorelin Aeterna Zentaris, INN-macimorelin (europa.eu) There was no apparent issue. Why are the range so different in this trial?