Tuesday, November 22, 2016 2:14:54 PM
The company received a shareholder inquiry last year about the PFS primary endpoint clinical trial registry change. At the time the Company updated the data collection date to Sept of this year (plus a month of delay for new screening) which would mean Oct 2016. The Company is also on SEC record in August 2015 stating that over 300-patients are enrolled into the main trial arm. And so there is nothing they can do to slow down events. Over 300 patients were on protocol. If the reached the 248-patient events last month, then there would have been no good reason to push out the "primary completion end date". But hey, that's just me.
Northwest Bio - SEC statement on 10-8-15:
?
Shareholder inquiry: What is going on with the change in completion date of the Phase 3 trial on clinicaltrials.gov? Is there a new change or delay in the trial?
Company answer: No, there is no new change or delay in the Phase 3 trial. In all of our public presentations all year long, we have stated that we anticipated finishing the recruitment this fall, and reaching the primary endpoint around approximately the end of summer or September of next year. The clinicaltrials.gov profile was very out of date, and the change of date in that profile from September of this year to October of next year simply conforms the clinicaltrials.gov profile to the information we have provided publicly all year long, plus about a month of cushion to take account of the temporary hold on new screening for the trial as we announced in August.
We are also updating the profile to correct the number of patients. As stated in all of our presentations for over a year, the total enrollment will be 348. The clinicaltrials.gov profile was very out of date in listing 300. We will simply be conforming the number in the profile to the number we have long presented publicly.
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
Exxe Group Advances Platform Strategy and Share Structure Reduction Following Strategic Meetings • AXXA • Mar 11, 2026 1:03 PM
DRCR Pushes Forward With Implementation of 2026 Business Plan • DRCR • Mar 11, 2026 12:26 PM
Record Gold Prices Reshape Opportunities for Emerging Producers • LFLR • Mar 11, 2026 9:00 AM
C2 Blockchain Reports 803 Million DOG (Bitcoin) Holdings Following Strategic Accumulation of Bitcoin-Native Digital Assets • CBLO • Mar 10, 2026 8:00 AM
RENI Completes Due Diligence on Target Acquisition; Confirms Strong Asset Base and Operational Performance • RENI • Mar 5, 2026 10:15 AM
BlackStar Engages in Talks with U.S. Senate Banking Committee Team Covering the Digital Asset Market Clarity Act • BEGI • Mar 4, 2026 4:47 PM
