NorthWest Biotherapeutics Inc (NWBO): Addressed in my reply already. FDA do...

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NorthWest Biotherapeutics Inc (NWBO)

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Re: vator post# 439341

Friday, 01/28/2022 8:24:17 AM

Friday, January 28, 2022 8:24:17 AM

Addressed in my reply already.

FDA does not swing from the hip. Add patients to your study or change primary endpoint or both.

Decide an ECA is an acceptable, approvable design when a validated database does not exist…implausible.

Change your only pivotal trial design voluntarily for your lead asset with no existing product portfolio, please explain how this is not material? How about after data lock?

Sorry, bonkers

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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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