Tuesday, February 21, 2023 9:33:33 PM
sentiment_stocks,
The various points of reference based on circumstances do point to having both an MIA and MAA in process even if neither is fully complete based on them both being approvable. The other issue is that there could be side by side submissions being worked on with the artisan method and the Edens method. In this case an approved but not technically finalized or desired for end use process could be utilized to begin the MAA process based on an interim MIA approval with the potential switch to the other process based on qualifying it prior to an announcement of MAA approval. Convoluted? Maybe but seems doable and not too much unlike the FDA process. Would NWBO announce this? Probably not as they would want to announce MIA acceptance for Edens first if possible. The technicality comes with any bridge MIA under the artisan method needing to be approved first to get things rolling even if both MIA approvals for different methods and the MAA approval might be announced nearly simultaneously later.
I think biosectinvestor has a better handle on the realities and ILAP process but if what I mention is really possible then it might even be likely. Best wishes.
The various points of reference based on circumstances do point to having both an MIA and MAA in process even if neither is fully complete based on them both being approvable. The other issue is that there could be side by side submissions being worked on with the artisan method and the Edens method. In this case an approved but not technically finalized or desired for end use process could be utilized to begin the MAA process based on an interim MIA approval with the potential switch to the other process based on qualifying it prior to an announcement of MAA approval. Convoluted? Maybe but seems doable and not too much unlike the FDA process. Would NWBO announce this? Probably not as they would want to announce MIA acceptance for Edens first if possible. The technicality comes with any bridge MIA under the artisan method needing to be approved first to get things rolling even if both MIA approvals for different methods and the MAA approval might be announced nearly simultaneously later.
I think biosectinvestor has a better handle on the realities and ILAP process but if what I mention is really possible then it might even be likely. Best wishes.
Recent NWBO News
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:38:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- 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
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- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
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- 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
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- 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
