de tuinman schreef op 19 augustus 2020 16:33:
[...]
www.fiercebiotech.com/biotech/fda-rej...The sperm toxicity concern dates back to toxicology studies of the 200-mg dose in rats and dogs. The results, and the FDA’s response to them, led Galapagos to limit the maximum daily dose at U.S. sites in its phase 2 DARWIN clinical trial program to 100 mg. Gilead and Galapagos subsequently got the green light to enroll a 200-mg cohort in their phase 3 program.
Dit was al een kleine waarschuwing.. Hoewel deze later wel weer werd toegestaan.
To allay the toxicity concerns, Galapagos ran further preclinical tests, monitored men enrolled in its clinical trials and, with Gilead, initiated the MANTA and MANTA-RAy studies. The work and talks with the FDA led Gilead and Galapagos to think they could seek approval without MANTA and MANTA-RAy data.
“Neither of them are needed to … gate filing,” Walid Abi-Saab, chief medical officer at Galapagos, told attendees at an R&D event in November. “Once they become available, then they will be used, whether it will be … during the review process or afterwards.”
Waarom kregen GIL en Gal het idee dat deze onderzoek uitslagen niet nodig waren? Dat moet het FDA toch hebben gecommuniceerd? Ik begrijp er echt geen %^$&* van!