Replies to Post #484628 onNorthWest Biotherapeutics Inc (NWBO)

Replies to #484628 on NorthWest Biotherapeutics Inc (NWBO)

06/08/22 4:16 PM

Good timeline Chiugray. Thanks for sharing.

One issue/thought: I believe if they submitted a BLA in Q1 of 2021 we would have already been past at least one PDUFA date. That means we are either approved, denied or we have a deficiency. I would think an approval would have been PR'ed and we would know about it. A denial is material and would have to be pr'ed. A Complete Response Letter outlining a deficiency is also material and would have to be PR'ed. Because we have none of these PR's and no news of an approval, I don't believe this part of the timeline to be correct. IMO.

Chiugray

06/08/22 8:29 PM

#484733 RE: Chiugray #484628

(Updated #2) I am resurfacing clues and timeline hints that possibly NWBO has already filed the BLA and regulatory approvals for DCVax-L are closer than we all think. TBD because this is a hypothesis, given the FDA is prohibited from disclosing if one was filed and that Northwest is not required to and has not disclosed either. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547098/

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- Dec’19, FDA draft guidance supporting ECA in clinical trials (Docket: FDA-2019-D-4964).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, key parts of the BLA relating to ECA were substantially completed by Q1’21?
(The ability to incorporate the revised SAP (use ECA) into a BLA requires having compiled a contemporaneous control database and how the ECA would be used in statistical analyses.)
- 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 presents an overview of the statistical analyses in using an ECA. (Mount Sinai,

at 25.41)

During the next several months, the BLA was submitted to regulatory agencies under a regular, rolling, or Real-Time-Oncology-Review program?
Typically, 10 months is added to the filing date to start the clock which calculates the PDUFA date for RA to act. This action date may be shorter but longer if, for example, the FDA needed to extend it by several months for Covid reasons.

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 IHub 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.”