NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

(Updated) I am resurfacing clues and timeline hints that possibly NWBO has already filed the BLA and regulatory approval DCVax-L is closer than we all think. TBD because this is a hypothesis, and given the FDA is prohibited from disclosing if one was filed, and Northwest is not required to and has not disclosed either.

The process of preparing a BLA started here?
(Step one is the revised SAP incorporating use of external control arms.)
- Dec’19, FDA draft guidance supporting ECA in clinical trials (Docket: FDA-2019-D-4964).
https://fintel.io/doc/sec-nwbo-10q-northwest-biotherapeutics-2021-january-15-18642

- 2019, Flipper wrote “IMO, the SAP was completed by the end of 2019. This… should have included assembled ECA data.”
(IHub post 455286, 3/30/22)

The process of completing a BLA started here?
- Q3'20 10Q disclosed NWBO entered into agreements to prepare "potential applications for regulatory approvals of the DCVax-L product."
https://fintel.io/doc/sec-nwbo-10q-northwest-biotherapeutics-2021-january-15-18642

- Oct'20 the trial's data was formally locked
https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/

- Oct'20 the SAP was updated in the official EU clinical trial registry
(ATLnsider, IHub post 315347)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB#summary
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

6 months later, a BLA had already been submitted in Q1’21?
(The ability to incorporate the revised SAP (use ECA) into a BLA requires having compiled a contemporaneous control database and pro
- Apr’21 Linda Liau presents a contemporaneous control database compiled from other GBM trials for use in an ECA. (Biomedical Engineering Seminar, Univ of Utah, slides from Dr. Bala https://www.dr-bala.net/NWBO/LL%20Talk%20Utah.pdf

- May'21 Linda Liau gave presents an overview of the statistical analyses in using an ECA.
(Mount Sinai,

at 25.41)

6 months later, NWBO has tentative approval to premarket promote by the FDA?
(Pharmaceutical ad laws and regs do not allow drugs, not yet approved, to be advertised to doctors, except under preapproved premarket promotion programs. Mi Dendream post 419940)
- Sep’21: full page ad ABTA conference shows DCVax(r) (trademarked product name) and Immune Therapies (marketing claim)
https://www.abta.org/wp-content/uploads/2021/09/2021-ABTA-NC-ProgramBooklet_Final.pdf
(Page 14)

- Nov’21: Tote bag was given at SNO, a professional conference for oncologists, showing again DCVax(r) (trademarked product name) and Immune Therapies (marketing claim)
https://stocktwits.com/mne30m3/message/407555163

6 months later, we are waiting for approval, not a BLA filing?
- May'22 the revised SAP was finally updated on clinicaltrials.gov. So why update the USA registry updates 18 months after the EU did? Possibly there was a change in status with the FDA, a signal of completion of a tentative status it had given for "premarket promotion."
https://clinicaltrials.gov/ct2/show/NCT00045968?term=dcvax-l&draw=2&rank=3

- May’22 Iwasadiver, IHub Post# 482729
“Dr. Ashkan just shook his head last night when we were talking. He said the hurdles of the FDA process is so bogged down with politics and business interests compared to UK/EU/Canada. He expects quick approvals there and that if not quickly done soon after in the US the pressure from patients and advocacy groups will be overwhelming. If you can simply drive over the bridge to Canada to pay for DCVax the FDA will look completely useless.”