Nantkwest / Immunitybio -> IBRX WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: captainpump97

https://x.com/actionfixesfear/status/2056971079504306571?s=46

Ich meine… wenn es keine Hintertür gibt, kann man auch direkt approven oder 😅

Klingt halt als wenn man sich eine Hintertür offen lässt. Auch das hier : The Agency further provided insight as to the focus of the review of this sBLA by stating, “The scientific data detailing these overlapping features will be the focus of the review of this sBLA to determine if there is adequate justification to allow for such an extrapolation and expansion of the indication of Anktiva with BCG to include the treatment of patients with BCG-unresponsive NMIBC with papillary tumors,”

Klingt halt als wenn man sich eine Hintertür offen lässt. Auch das hier : The Agency further provided insight as to the focus of the review of this sBLA by stating, “The scientific data detailing these overlapping features will be the focus of the review of this sBLA to determine if there is adequate justification to allow for such an extrapolation and expansion of the indication of Anktiva with BCG to include the treatment of patients with BCG-unresponsive NMIBC with papillary tumors,”

* ImmunityBio secured FDA acceptance for review of a supplemental BLA seeking to expand ANKTIVA with BCG into BCG-unresponsive non-muscle invasive bladder cancer with papillary-only disease. * The FDA set a PDUFA target action date of Jan. 6, 2027. * The filing is supported by QUILT-3.032 Cohort B data in 80 patients, including 12-month disease-free survival of 58.2%. Von Trade Republic geklaut.