Followers | 228 |
Posts | 14573 |
Boards Moderated | 1 |
Alias Born | 03/29/2014 |
Tuesday, June 11, 2019 11:45:14 AM
Good point Biosectinvestor… this was not a TRIAL HALT. It was actually a screening halt. No more patients could enter the screening process than those already in it.
Well not quite. The interim analysis intended for the summer of 2015 was to be an efficacy analysis.
The treatment for the placebo patients begins with standard of care, and the same is being given to the treatment patients. So it’s hard to argue, IMO, that the treatment BOTH the placebo AND TREATMENT patients were receiving was harmful. Probably most agree rad/chemo is rather harmful, but both sets of patients were receiving it. Additionally, some would argue that SOC actually has some benefit to at least the methylated patients. Yes, this is the short argument back to this claim, but it has a lot of merit, IMO. Just something to consider.
The regulatory agency would, IMO, have to tell the company why they are halting the screening process. They can’t just come along, halt a trial, destroy the company’s market cap and possibly ability to get the trial to completion, without telling them the reason why. So I disagree with you on that point. Additionally, the company seems to be fully aware there was an issue with psPD, and that began with Dr. B remarking in a live presentation that pseudo progression can wreak havoc on immunotherapy trials. The Journal of Translational Medicine article went further and stated that pseudo-progression is a “known confounding phenomenon, and that they intend to use the latest criteria FOR THIS TRIAL to determine that. And further, they all claim to be blinded, and so Avii et al can relax knowing that they will be allowed to change the progression criteria for that reason.
I suspect that instead, the hedge funds were in the know as to the problem because someone on the regulatory side leaked it to them. And has that worked out very well for them so far, although as NWBO management points out, they are still here, and this trial is moving towards data lock, finally.
I absolutely and completely agree with you on this point.
Well fortunately, in this trial, that has not been suggested. But it is occurring in other checkpoint inhibitor immunotherapy trials. I think you probably meant to write pseduoprugression.
Now wait a second... the earth isn’t flat?
:)
Recent NWBO News
- 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
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • BLO • Apr 25, 2024 8:52 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM