NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

They are on a timeline that we are not aware of. They march to the beat of a different drummer, or BP, or some such motivation. The extensive time for the SAP just was another way to achieve that timeline, imho.

flipper44,

maybe we can expect a Kite - Gilead scenario:

Dec.9, 2019: TLD
Dec.11, 2019:submission of a BLA to the FDA.

ORLANDO, Fla.--(BUSINESS WIRE)--Dec. 9, 2019-- Kite, a Gilead Company (Nasdaq: GILD), today announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL). After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.
https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-presents-positive-results-from-pivotal-zuma-2-trial-in-relapsed-or-refractory-mantle-cell-lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE)--Dec. 11, 2019-- Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The BLA submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.

https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-submits-biologics-license-application-to-us-food-and-drug-administration-for-companys-second-car-t-cell-therapy

Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL.
https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/kite-submits-biologics-license-application-to-us-food-and-drug-administration-for-companys-second-car-t-cell-therapy