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Wednesday, October 26, 2022 6:29:31 AM
The time period a normal functioning biotech would, under the same circumstances, have already submitted a request for approval for DCVAXL has long come to pass.
Just a quick question: Have you ever held a small, pre-commercial biotech through the BLA regulatory process? Or ever held a micro-cap biotech after reporting a successful pivotal, P3 trial? If so, how long was it after the trial ended was the BLA submitted and the drug approved? Just curious if you have any personal experiences with other biotechs in the same boat as NW Bio and compare those time-lines to what has/is happening here.
Therefore one can conclude that NWBO management is deliberately not submitting a request for approval
Did NW Bio telegraph submittal of PIP application in the UK? No, they did not. But this was the first step in MAA approval and was required for commercialization. Management made this move back in Feb. 2022 but only PR'ed the actually approval of the PIP trial design and plan. This would suggest submission of a MAA in the UK will not be PR'ed, only the actually approval of the MAA.
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
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