Hulskof schreef op 15 november 2022 06:45:
From YMB Holden Holden
8 hours ago
"These were added on Oct 28. Important. Also important that three extra doses were added from 15 to 18 at the full 200mg dose, extending the dosing to weeks 172, 184 and 196 (with TEAEs measured to week 208).
21. Incidence of Anti-Drug Antibodies to ARO-AAT
[ Time Frame: Participants Without Fibrosis: Pre-dose on Days 1 & 29, and on Days 113, 197 and 281; Participants With Fibrosis: Pre-dose on all dosing visits (Days 1, 29, 113, and every 12 weeks up to Week 196) ]
22. Change from Baseline in Metavir Fibrosis Stage at Post-Dose Biopsy for Participants with Fibrosis
[ Time Frame: Post-dose at Weeks 48 (+/- 2 weeks) or Week 72 (+/- 4 weeks) or Week 96 (+/- 4 weeks) ]
No additional patients. So if you insist on using conventional "phase" numbering, this extended study gives rise to AA and p3 while a post marketing p4 study will simply be a data collection exercise based on post-marketing biopsis conducted by docs who's patients have been treated for the duration of the dosing schedule as will be noted on the labeling.
In short, IMO, this is a pivotal trial. To support that opinion, I suggest investors consider the changes from exclusively ARO AAT to TAK 999 and Fazirsiran. That is the first CT reference to 999 and clearly and indication TAK has taken on all forward development/commercialization of the drug.
This drug, which is what TAK 999 is, will gain AA/commercial labeling approval with the ability to represent fibrosis reduction and a p4 postmarketing requirement."
AA zou de koers goed doen.