Monday, November 28, 2016 8:01:52 PM
Hypothetical example of a screening hold which would not be an untoward event:
Everyone is living longer.
Trial is substantially enrolled but because every one is living longer it looks like it will take much longer than expected for events to occur.
Hold on screening and enrollment because they do not want to further delay the trial and data coming out of the current patient population appears to be adequate for approval.
LOL.
In your example the hold would slow down the results, not speed them up.
Further, you are changing the trial based on known results. Which is a huge no-no.
And lastly, the FDA would not need to place a hold to do this. The sponsor could simply stop enrolling.
The FDA hold is a major problem, and everybody who is not smoking hopeium knows it.
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
ECGI Advances Mortgage Tokenization Pilot as Institutional Market Rails Continue to Develop • ECGI • Mar 17, 2026 8:30 AM
Record Gold Prices Reshape Economics of New Mine Development • SNWGF • Mar 16, 2026 10:46 AM
Cannabix Technologies Announces Commercial Launch of Marijuana Breath Test (MBT) • BLOZF • Mar 16, 2026 8:37 AM
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
