pe26 schreef op 4 maart 2021 21:12:
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Welke indruk vind jij dat er is gewekt omtrent Filgotinib's hoge dosis en het mogelijk effect op fertiliteit bij mannen..?
MANTA Outcome (Kempen rapport)
"The 20-30% non-inferiority margin for the primary endpoint as seen in other
trials sets a very low bar for the trial to succeed. Essentially, such criteria implies
a massive reduction in sperm concentration in a high proportion of patients
(>25%), which in our view is not supported by the preclinical data.
Limited impact on label and marketing
In the case of a positive outcome, the mention of testicular toxicity is likely to
be limited to the preclinical pharmacology section with a negligible impact on
prescription and marketing as seen with examples mentioned above".
In die zin ben ik blij met deze data, en volgens mij zijn er meerdere die zo over denken.
Wat is jouw idee bij deze MANTA data..?