Saturday, November 29, 2025 9:51:56 AM
DD, I wasn't trying to take sides. Took no exception to what you had said in prior posts. My position was that adding Flaskworks to the MA in midstream adding six months to possibly a year or longer to the MA process was significant enough to require notifying shareholders of the change. I take exception. significant enough to meet the requirement. Your own statements from your last posts confirm that the addition of Flaskworks will likely add up to a year to the process. You can quote CMC requirements, but NWBO is still a US company subject to SEC regulations and the right thing to do was notify shareholders of the change. I was only offering my opinion that notification should have been done.
"If manual Grade B were the intended commercial process, MHRA could have approved months ago.
Manual is already fully licensed, inspected, validated, and used for Specials. There is nothing left to review."
"The process is completed once the Grade C suite is finished and validated, which is expected by mid next year if you actually read NWBO's last PR"
"The Typical timeline would be 6 months extra counted after the regular 210 clock on days have passed (depending on the readiness of the facility (Grade C suite and the MHRA inspections of Flaskworks). My best estimate: end Q1 2026, assuming the validation of the first Grade C suite completes early next year."
"If manual Grade B were the intended commercial process, MHRA could have approved months ago.
Manual is already fully licensed, inspected, validated, and used for Specials. There is nothing left to review."
"The process is completed once the Grade C suite is finished and validated, which is expected by mid next year if you actually read NWBO's last PR"
"The Typical timeline would be 6 months extra counted after the regular 210 clock on days have passed (depending on the readiness of the facility (Grade C suite and the MHRA inspections of Flaskworks). My best estimate: end Q1 2026, assuming the validation of the first Grade C suite completes early next year."
Recent NWBO News
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- 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 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
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- 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
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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
