Thursday, August 08, 2024 10:06:19 AM
Investor082,
Optimizing an already acceptable GMP designed unit and getting multiples installed inspected and passed for equivalence isn’t going to take forever and use in trials can happen before full commercial validation.
A partner certainly could be announced at approval and it will likely be tied to Flaskworks development but may delay major funding until Flaskworks validation to incentivize final steps but also help prevent more rapid development of Direct. The slow down of Direct development as a strategy may have changed now for Merck and BMY since their new versions of checkpoint inhibitor administration come with an increased risk of death. This situation likely pushes them to want to develop Direct more quickly into an approved and commercially available product as their inhibitors may be left to face generic competition. The issue this creates is that they will be reduced more into the role of banker and book keepers rather than true development partner as Direct will be in a very advanced state of development by the time they come on board and all that is left is integration of supply chain, assuring manufacturing capacity and then distribution which Walgreens is already preparing for as the approval of L approaches.
Big pharmas are definitely going to be evaluating when they need to make their moves as marketing approval and Flaskworks validation approach for NWBO. There will not likely be as much time between these two events as many anticipate and any favorable decision for NWBO with the spoofing litigation raises awareness to a whole new level. If this comes near approval everyone will realize what this means for the perps and NWBO recognition as the true threat to big pharma that it is. Awareness about what Flaskworks means and Direct capturing the attention and imagination of the masses will create some fireworks that big pharmas will definitely want to be linked to by then or be left behind. Best wishes.
Optimizing an already acceptable GMP designed unit and getting multiples installed inspected and passed for equivalence isn’t going to take forever and use in trials can happen before full commercial validation.
A partner certainly could be announced at approval and it will likely be tied to Flaskworks development but may delay major funding until Flaskworks validation to incentivize final steps but also help prevent more rapid development of Direct. The slow down of Direct development as a strategy may have changed now for Merck and BMY since their new versions of checkpoint inhibitor administration come with an increased risk of death. This situation likely pushes them to want to develop Direct more quickly into an approved and commercially available product as their inhibitors may be left to face generic competition. The issue this creates is that they will be reduced more into the role of banker and book keepers rather than true development partner as Direct will be in a very advanced state of development by the time they come on board and all that is left is integration of supply chain, assuring manufacturing capacity and then distribution which Walgreens is already preparing for as the approval of L approaches.
Big pharmas are definitely going to be evaluating when they need to make their moves as marketing approval and Flaskworks validation approach for NWBO. There will not likely be as much time between these two events as many anticipate and any favorable decision for NWBO with the spoofing litigation raises awareness to a whole new level. If this comes near approval everyone will realize what this means for the perps and NWBO recognition as the true threat to big pharma that it is. Awareness about what Flaskworks means and Direct capturing the attention and imagination of the masses will create some fireworks that big pharmas will definitely want to be linked to by then or be left behind. Best wishes.
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
