Monday, October 31, 2022 3:23:07 PM
Legend431, I do not compare NWBio to other biotech companies. I do not compare the DCVax vaccine platform to other new drugs or biologics. The DCVax vaccine platform will be a foundational / core part of the new standard of care (SOC) to treat ndGBM and rGBM patients worldwide. It is my hope, that the DCVax vaccine platform will become a breakthrough new treatment tool to treat all of most solid tumor cancers worldwide.
NWBio has been working closely with, and communicating and coordinating with regulatory authorities in the US, Canada, UK, Germany and the rest of the EU, with the primary view and goal of getting DCVax-L commercially approved to treat both ndGBM and rGBM patients.
NWBio developed a plan, after data-lock, that included a "Quiet Period" for the regulatory processes to play out, and their plans also included having the DCVax-L Phase III results published in a top tier peer-reviewed medical journal about the same time as the official top line data (TLD) results are officially PRed and released directly by NWBio. The selected journal publication also has an embargo policy, and NWBio is making sure that the Quiet Period also keeps them in compliance with these embargo policies.
I have confidence in NWBio's leadership and its senior management team, I don't feel a need to second guess them, or question their timing. I understand that they have been directly communicating with the regulators, and they have access to a lot more first-hand information than anyone on this board.
I have taken full advantage of the Quiet Period, by buying and accumulating more NWBO shares since data-lock (October 2020), and even more so since May 10, 2022, after it was disclosed that the DCVax-L Phase III trial was a success, and it met both its Primary and Secondary Endpoints with statistical significance.
NWBio has been working closely with, and communicating and coordinating with regulatory authorities in the US, Canada, UK, Germany and the rest of the EU, with the primary view and goal of getting DCVax-L commercially approved to treat both ndGBM and rGBM patients.
NWBio developed a plan, after data-lock, that included a "Quiet Period" for the regulatory processes to play out, and their plans also included having the DCVax-L Phase III results published in a top tier peer-reviewed medical journal about the same time as the official top line data (TLD) results are officially PRed and released directly by NWBio. The selected journal publication also has an embargo policy, and NWBio is making sure that the Quiet Period also keeps them in compliance with these embargo policies.
I have confidence in NWBio's leadership and its senior management team, I don't feel a need to second guess them, or question their timing. I understand that they have been directly communicating with the regulators, and they have access to a lot more first-hand information than anyone on this board.
I have taken full advantage of the Quiet Period, by buying and accumulating more NWBO shares since data-lock (October 2020), and even more so since May 10, 2022, after it was disclosed that the DCVax-L Phase III trial was a success, and it met both its Primary and Secondary Endpoints with statistical significance.
Recent NWBO News
- 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 EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/26/2025 05:15:34 AM
- 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
