NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Other biotechs do PR rolling review beginning/completion/acceptance. Vertex and Adaptimmune examples below.

Vertex and CRISPR Therapeutics Announce Global exa-cel Regulatory Submissions for Sickle Cell Disease and Beta Thalassemia in 2022
- Exa-cel will be submitted to the U.S. FDA for rolling review beginning in November, with completion of the U.S. submission package in Q1 2023 -
- EMA and MHRA submissions are on track for Q4 2022 -
- Exa-cel granted Fast Track, Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations in the U.S., and Priority Medicines (PRIME) and Orphan Drug designations in Europe -
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Sep. 27, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced that Vertex has concluded discussions with the U.S. Food and Drug Administration (FDA), and the FDA granted exagamglogene autotemcel (exa-cel) a rolling review for the potential treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). Vertex will submit its biologics licensing application (BLA) for exa-cel for rolling review, beginning in November 2022 and expects to complete the submission by the end of Q1 2023.

Vertex and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
-EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review procedure has begun as of January 2023-
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Apr. 3, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the rolling Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The BLAs include requests for Priority Review, which if granted, would shorten the FDA’s review of the application to eight months from the time of submission versus a standard review timeline of 12 months.

FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
- First CRISPR gene-editing filings to be accepted for review by FDA -
- FDA grants Priority Review for severe sickle cell disease (SCD) and Standard Review for transfusion-dependent beta thalassemia (TDT) –
- PDUFA target action date of December 8, 2023, for SCD and March 30, 2024, for TDT –

And on que 2 months later

BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Jun. 8, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The FDA has granted Priority Review for SCD and Standard Review for TDT and assigned Prescription Drug User Fee Act (PDUFA) target action dates of December 8, 2023, and March 30, 2024, respectively. Updated data from the pivotal trials supporting the regulatory submissions will be presented at the Annual European Hematology Association Congress on June 11, 2023.

Adaptimmune Announces Initiation of Biologics License Application (BLA) Submission for Afami-cel, Its First-Gen Engineered TCR T-cell Therapy targeting MAGE-A4, For the Treatment of Synovial Sarcoma
December 23, 2022 1:20pm EST
- Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumor -
-Synovial sarcoma has a high unmet medical need and the pivotal trial met its primary endpoint with an overall response rate of ~39% after a single dose of afami-cel -
- Adaptimmune plans to complete its rolling BLA submission for afami-cel in mid-2023; and with RMAT status for synovial sarcoma, the application will be eligible for priority review by the FDA -

Why on earth they wouldn't PR positive news I wouldn't know. They could very well be doing what you're thinking and I wouldn't be too surprised but I'll believe it when I see it.