Thursday, June 08, 2023 8:42:40 PM
ATLnsider, basically yes, I would be pleasantly shocked to see that they are now applying for a tissue agnostic cancer therapy approval as opposed to setting the stage for it in short order.
While I think their safety profile will enable this in rapid fashion in the future, and their MOA theoretically demonstrates it may apply to all solid tumors, their body of data is insufficient to prove better than current SOC therapies across the board. While I do not think it is impossible I think it is a remote possibility due to the scarcity of data that I am aware of. I guarantee when Merck achieved their tissue agnostic approval the application was full of supportive studies, multiple confirmatory studies across multiple cancers and a plethora of publications supporting the theory of Keytruda's MOA. I don't think I am being negative, just realistic.
If NWBO achieves an MAA which includes FW to support GBM I will be elated because I think parlaying that into a platform for all solid tumors will be a direct and time efficient possibility for an experienced pharma partner to help them do. I will be fine to be pleasantly shocked if it occurs but I am planning on GBM with FW initially and a development platform to come for all solid tumors.
A while ago I spoke about data and development plans to determine length of investment hold post GBM approval. Now we are more enlightened about the GBM data, much of which can be utilized across solid cancers theoretically. This is the first real enlightenment of their development plans, which I think is a significant revelation.
If they can just attain MHRA approval for GBM with FW in the filing, and, get their finances on track, this will be an amazing story. As I have also stated I am hoping for a major BP partner in the near future to help them take this onward and upward, all just my opinions.
ATLnsider, your posts are wonderful, thx.
GLTA
While I think their safety profile will enable this in rapid fashion in the future, and their MOA theoretically demonstrates it may apply to all solid tumors, their body of data is insufficient to prove better than current SOC therapies across the board. While I do not think it is impossible I think it is a remote possibility due to the scarcity of data that I am aware of. I guarantee when Merck achieved their tissue agnostic approval the application was full of supportive studies, multiple confirmatory studies across multiple cancers and a plethora of publications supporting the theory of Keytruda's MOA. I don't think I am being negative, just realistic.
If NWBO achieves an MAA which includes FW to support GBM I will be elated because I think parlaying that into a platform for all solid tumors will be a direct and time efficient possibility for an experienced pharma partner to help them do. I will be fine to be pleasantly shocked if it occurs but I am planning on GBM with FW initially and a development platform to come for all solid tumors.
A while ago I spoke about data and development plans to determine length of investment hold post GBM approval. Now we are more enlightened about the GBM data, much of which can be utilized across solid cancers theoretically. This is the first real enlightenment of their development plans, which I think is a significant revelation.
If they can just attain MHRA approval for GBM with FW in the filing, and, get their finances on track, this will be an amazing story. As I have also stated I am hoping for a major BP partner in the near future to help them take this onward and upward, all just my opinions.
ATLnsider, your posts are wonderful, thx.
GLTA
Bullish
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
