Replies to post #483893 on NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Yep, try2.

[Bright Boy]

T2,

Thank you, Thank You, Thank You!!! That's the most important information I've received in the last year!! I was laboring under the illusion that all BLA submissions were a material event requiring public disclosure!!! Not so based on the information you provided!!!

I'm not sure how many shareholders realize that, but I'll bet very few do. My guess is that we are very, very close to having our JA and we may be very, very close to approval at the FDA, maybe as close as we are at the MHRA !!!

Very exciting times ahead for Northwest, it's shareholders and cancer patients worldwide!!!

Cheers and thanks again,

BB

[Chiugray]

Thanks Tryn2,

Current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing the existence of pending New Drug Applications (NDAs) or Biologics License Applications (BLAs) unless previously publicly disclosed or acknowledged.1 Applicants may disclose applications in press releases, Securities and Exchange Commission (SEC) filings, or in other media; how frequently they do so is not known.

May be or not, but resurfacing TBD clues and timeline hints that possibly a BLA has already been filed and approval is closer than we think:

A start time?
- Q3'20 10Q disclosed NWBO entered into agreements to prepare "potential applications for regulatory approvals of the DCVax-L product."
- Oct'20 the trial's data was locked
- Oct'20 the SAP was updated in the EU registry

6 months later, a BLA completed?
- Apr & May'21 Linda Liau gave presentations discussed a contemporaneous control database and how the ECA would be used in statistical analyses.

6 months later, a clue of tentative approvals with FDA?
(Pharmaceutical ad laws and regs do not allow drugs, not yet approved, to be advertised to doctors, except under preapproved premarket promotion programs.)
- Sep 2021: an ABTA full page ad shows DCVax(r) (product name) and Immune Therapies (marketing claim)
- Nov 2021: a SNO tote bag was given at a professional conference for oncologist, showing again DCVax(r) (product name) and Immune Therapies (marketing claim)

6 months later, a clue that we are waiting for approval, not a BLA filing?
- May'22 clinicaltrials.gov was updated with the revised SAP, maybe a change in status with the FDA, a signal of completion in the tentative status it had with "premarket promotion"
- May’22 Iwasadiver, 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.

[antihama]

Yes, it's the biotech's job to shout from the highest rooftop (i.e. PR) that they've submitted a BLA. The FDA doesn't give a crap. The FDA would have 1 or 2 months to accept or reject the application for review; 2m is for normal review, 1m is for accelerated review (BTD, etc). Acceptance of BLA for review is another milestone which is PR'd and a bigger biggie (rejection of a BLA for review is a material event IMO) than submitting the BLA for review. Speaking of Breakthrough Therapy Designation, that is another milestone that is shouted from the highest rooftops which occurs not to long after TLD. Considering that NWBO has that data (the primary and first secondary endpoints) and much more that is needed to be submitted before we heard it at NYAS, we should get the BLA PR any day now or at least within the next month if nothing is amiss.