Thursday, May 18, 2023 11:35:48 AM
My timelines after MAA Submission (give it 4 months / 120 Days at latest)
End of May - Approval in Sept 2023
End of June - Approval in Oct 2023
End of July - Approval in Nov 2023
End of Aug - Approval in Dec 2023
I cannot make judgement on the insanity of the SP until submission and approval in the UK, at that point I will re-access how the SP moves and see if along the way any partnerships talk heat up.
Plans for 2023 Per ASM
Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year. The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license,(completed) which is one of the pre-requisites for submission of an application for product approval. In parallel, the top priority and intensive focus will be continued preparation of an application package for product approval, as well as the supporting documentation. The Company already made substantial progress on the application package during 2022, and the Company plans to submit an application as soon as possible after the pre-requisites and preparations are completed.
During 2023, the Company anticipates that additional key areas of focus will include:
Continued preparations for scale-up capability, with further implementation of streamlining product “release” processes;
Expansion of the operation in Sawston following completion of the Phase 1B buildout;
Continued development of the Flaskworks system, including choice of the system version to take forward;
Commencing the pediatric clinical program required under the PIP;
As resources permit, pursuing clinical trials with combination treatment regimens.
Recent NWBO News
- Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher • AllPennyStocks.com • 06/17/2024 04:40:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 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) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
FEATURED North Bay Resources Acquires Mt. Vernon Gold Mine, Sierra County, California, with Assays up to 4.8 oz. Au per Ton • Jul 18, 2024 9:00 AM
VAYK Expects Revenue from First Airbnb Property Starting from August • VAYK • Jul 18, 2024 9:00 AM
Nightfood Holdings Signs Letter of Intent for All-Stock Acquisition of CarryOutSupplies.com • NGTF • Jul 17, 2024 1:00 PM
Kona Gold Beverages Reaches Out to Largest Debt Holder for Debt Purchase Negotiation • KGKG • Jul 17, 2024 9:00 AM
Avant Technologies Welcomes Back Former CEO with Eye Toward Future Growth and Expansion • AVAI • Jul 17, 2024 8:00 AM
HealthLynked Expands Telemedicine Nationwide • HLYK • Jul 17, 2024 8:00 AM