RE:RE:New Press Release - COSCIENS Biopharma Inc. Announces Top-Line Results of Phase 3 DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiencylscfa wrote: Who's the bonehead designing these studies? Why not do the 2 Macimorelin tests first, followed by the comparator tests? Why the hell do comparator tests in between Macimorelin tests?
It was suppose to show macimorelin's reproducability at two meaningfully different time points. Putting time between the two macimorelin tests would have helped prove macimorelin could produce the same results at two meaningfully different time points.
If the industry is over-diagnosing growth hormone deficiency with the two other tests does it have a problem and should the FDA accept the higher cut-off for macimorelin?
"Based on this, top-line data present an ‘optimal’ growth hormone (GH) cut-off point of 25.59 ng/mL, which is substantially higher than the standard cut-off points of 7-10 ng/mL as defined in current guidelines with existing tests."