Saturday, June 28, 2025 7:59:35 PM
The problem here is that you often refer to reasonable, facts-supported projections as pumping. For example, concluding that NHS/MHRA's
1. Decentralized POC manufacturing framework that seems tailor-made for NWBO’s DCVax-L as there’s currently no other therapy in the UK pipeline even remotely aligned with it as is DCVax-L.
2. Evolving regulatory framework has effectively shifted toward the very trial design pioneered by NWBO in its DCVax-L Phase III study.
3. High-Cost Drugs list with IFR access of DCVax-L for GBM and potentially other cancers is rare and would not be granted if a rejection were imminent or already issued.
4. Lack of back-log now processing 100% of national license applications within statutory timelines. A rejection would have been communicated by now by MHRA and/or NWBO. MHRA's full attention is now on NWBO.
5. Approved DCVax-L GMP and HTA MFG licensing.
all equate to imminent approval. No guarantee here but, given the above (and there's a lot more supporting facts to add), DCVax-L's imminent approval is a legitimate conclusion to draw. The conclusion that DCVax-L's MAA has been rejected, based on current facts from the MHRA, is completely bogus!
1. Decentralized POC manufacturing framework that seems tailor-made for NWBO’s DCVax-L as there’s currently no other therapy in the UK pipeline even remotely aligned with it as is DCVax-L.
2. Evolving regulatory framework has effectively shifted toward the very trial design pioneered by NWBO in its DCVax-L Phase III study.
3. High-Cost Drugs list with IFR access of DCVax-L for GBM and potentially other cancers is rare and would not be granted if a rejection were imminent or already issued.
4. Lack of back-log now processing 100% of national license applications within statutory timelines. A rejection would have been communicated by now by MHRA and/or NWBO. MHRA's full attention is now on NWBO.
5. Approved DCVax-L GMP and HTA MFG licensing.
all equate to imminent approval. No guarantee here but, given the above (and there's a lot more supporting facts to add), DCVax-L's imminent approval is a legitimate conclusion to draw. The conclusion that DCVax-L's MAA has been rejected, based on current facts from the MHRA, is completely bogus!
"Against stupidity, we are defenseless"-- Dietrich Bonhoeffer, an anti-Nazi German Theologian, executed in the final days of the Nazi regime.
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
