NorthWest Biotherapeutics Inc (NWBO): About Project Orbis: Recent numbers- MH...

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Re: biosectinvestor post# 423768

Saturday, 12/04/2021 6:37:06 AM

Saturday, December 04, 2021 6:37:06 AM

About Project Orbis:
Recent numbers- MHRA

11 Application Submissions
1 Regulatory Action

May 7, 2021
AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.
https://www.pharmatimes.com/news/az_tagrisso_first_to_win_mhra_approval_under_project_orbis_1369493

FDA Perspective

ASH Scientific Workshop on Streamlining Hematology Clinical Trials.
December 10, 2021
Angelo de Claro_FDA
Associate Director for Global Clinical Sciences
Oncology Center of Excellence (OCE)
Division Director for the Division of Haematologic Malignancies I
Center for Drug Evaluation and Research
U.S.Food and Drug Administration

Perspective_Scientific Workshop
Uploaded: Friday, November 26, 2021 at 2:35 PM EST
Min. 6:37
https://vimeo.com/650419152

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Recent NWBO News

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
Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/31/2025 09:23:24 PM

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