Tuesday, August 22, 2023 1:51:22 PM
I’ve been thinking a lot about the 700,000 extra pages our application for approval now has in it. It’s not so hard to imagine that the company went 100,000 pages or 200,000 pages over, but 700,000 is, well, a lot.
More recently I’ve been thinking about the sudden delay in submitting the applications to RAs. Both Thermo, who seems very close to management, and NICE, appeared surprised by the 3 month delay since Thermo sang April Showers bring May flowers.
Looking at the two together I’ve come to believe that the NWBO team had a pre-application meeting with MHRA and got a nod to apply for more than just nGBM and rGBM. What could take up 500,000 to 700,000 additional pages?
I also looked over Oncovir’s website and found no evidence that they have anything that’s passed any RA approval. But they do show a phase III trial under the category of vaccine. So I’m wondering if MHRA indicated to NWBO that they would entertain an application that included a third approval of DCVax + Oncovir’s Hiltonol??
What I think will happen is we see additional approvals:
1. nGBM
2. rGBM
3. nGBM with Hiltonol
4. rGBM with Hiltonol
Other possibilities??
1. Other gliomas
2. Ovarian cancer, which we completed a Ph 1 trial for years ago
3. Approval of DCVax as a tumor agnostic drug
4. Approval of DCVax-Direct as “the same” as DCVax-L
Those last 4 possibilities may include Ph 4 confirmation trials with Hiltonol.
I also believe that our first partnership/contract will be with Oncovir, Inc. We need a confirmed contract with them if we’ve going to move forward as a treatment with a 50% (cure?) rate in GBM. Oncovir signed a contract with a company seeking a Covid treatment in 2021, which makes me believe we need one too.
I would not be surprised to see us merge with Oncovir and form a new company that would allow us to uplist suddenly, forcing shorts to cover quickly. It appears Oncovir needs us at least as much, if not more, than we need them, so perhaps we might see a buy-out of Oncovir, Inc, using some C-shares and a seat or two on the board. Ever way, it would behoove use to become a new company and uplist
I strongly believe that we need to solidify our relationship with Oncovir, Inc., before we can move forward. I suspect they will be the first of the “active discussions” with entities that will be disclosed soon!
More recently I’ve been thinking about the sudden delay in submitting the applications to RAs. Both Thermo, who seems very close to management, and NICE, appeared surprised by the 3 month delay since Thermo sang April Showers bring May flowers.
Looking at the two together I’ve come to believe that the NWBO team had a pre-application meeting with MHRA and got a nod to apply for more than just nGBM and rGBM. What could take up 500,000 to 700,000 additional pages?
I also looked over Oncovir’s website and found no evidence that they have anything that’s passed any RA approval. But they do show a phase III trial under the category of vaccine. So I’m wondering if MHRA indicated to NWBO that they would entertain an application that included a third approval of DCVax + Oncovir’s Hiltonol??
What I think will happen is we see additional approvals:
1. nGBM
2. rGBM
3. nGBM with Hiltonol
4. rGBM with Hiltonol
Other possibilities??
1. Other gliomas
2. Ovarian cancer, which we completed a Ph 1 trial for years ago
3. Approval of DCVax as a tumor agnostic drug
4. Approval of DCVax-Direct as “the same” as DCVax-L
Those last 4 possibilities may include Ph 4 confirmation trials with Hiltonol.
I also believe that our first partnership/contract will be with Oncovir, Inc. We need a confirmed contract with them if we’ve going to move forward as a treatment with a 50% (cure?) rate in GBM. Oncovir signed a contract with a company seeking a Covid treatment in 2021, which makes me believe we need one too.
I would not be surprised to see us merge with Oncovir and form a new company that would allow us to uplist suddenly, forcing shorts to cover quickly. It appears Oncovir needs us at least as much, if not more, than we need them, so perhaps we might see a buy-out of Oncovir, Inc, using some C-shares and a seat or two on the board. Ever way, it would behoove use to become a new company and uplist
I strongly believe that we need to solidify our relationship with Oncovir, Inc., before we can move forward. I suspect they will be the first of the “active discussions” with entities that will be disclosed soon!
Recent NWBO News
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/21/2026 04:15:08 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 04:30:50 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/31/2026 09:04:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
