Replies to post #349296 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That is not a hard event... so it’s an attempt to save something that is not really relevant.

Upon their determination that they could not possibly even apply for approval, which is not the same as failure though their opinion could be wrong and there might be no chance of approval, they might be best served by not delaying their announcement. But I don’t see the difference there between marginal, failed or successful. When they are ultimately comfortable that they understand their data fully and have characterized it fully, in whatever way that might be, perhaps a scientific paper where critics get their data and review their conclusions, they might still be embargoed.

So they would be as transparent as possible and as complete in their analysis and explanation as possible. If it were a futility finding, early on, where they discontinued the trial, or they knew it failed at an early efficacy review, that’s an easier call.

In this instance the blinded data is so intriguing and there are sub-categories of patients discovered during the course of the trial, so I would expect that they’d want to fully understand the data and characterize it fully before they announced anything. It seems unlikely, given the blinded data that they would even mathematically would be able to fail across the board, particularly given the updated endpoints and SAP...

The 4 day rule in this complex a context with a category of data that is not listed under the mandatory disclosure list, is not the relevant issue. Fraud lawsuits due to misstatements, miscommunications or selective disclosure are the relevant issues. And other than selective disclosure (Reg FD), the other issues do not have a set timing other than the regular quarterly and annual reports, where they have to be careful not to miscommunicate. So the issue is trying to be as transparent and disclose meaningfully as soon as it is reasonably practicable give a broad range of discretion for them as managers and some potential cautionary areas with regard to any communications from the relevant regulators. They should avoid misleading, or leading investors in without disclosure, without a reasonable business judgment justification, like that they were reviewing data and key issues with subject matter experts.

[biosectinvestor]

At the point if that full analysis, think of them like material accounting / sales details that are not listed under the 8K (4 day rule instructions) explicitly. Let’s say their sales may be way down this quarter and they know quickly, revenues may be way down... and to investors that is “material”, but it waits until the next periodic quarterly or annual report, where it is required to be included as balance sheet detail... but no matter how “material” people might think that sales and accounting detail is, it’s not relevant to the 4 day rule unless it triggers one of the listed events, for instance a bankruptcy filing, or a material default on a loan. And then, the material event that triggered the 4 day notice was the event that triggered the 4 day rule disclosure, not the sales data, or the accounts detail. That may have been the ultimate cause of the event that triggered the 4 day disclosure rule, but receipt of the data itself was not the trigger. The trigger, in those cases was an irrevocable legal event... a bankruptcy or a default on a material contract.

Rejection of an application for approval or notice in some form from the FDA that a trial has no chance of approval, most likely an indication of rejection would trigger as a hard event. But, if it was just a decision that they don’t wan’t to bother anymore with this product as it is futile, then the longer they delay, the more likely they could be found to have perpetrated a fraud by hiding something. That’s not a 4 day rule issue, that is an issue if shareholders suing for fraud. It’s a different set of issues. Sooner disclosure mitigates such claims, and makes them more difficult to bring ir to claim large damages. But it’s not really a 4 day rule. They might disclose using the 8K form however. It would be a way for them to use the optional disclosure under that regulation. THIS is probably what makes non-lawyers think it’s under the 4 day rule... same form... just not die the same exact legal reason.

[Dan88]

utter nonsense.

First most investors don't think there is a tiny chance of trial failure in primary endpoint

Second if it were a failure measured by primary endpoint, the trial failed by its own definition according to its own SAP. It failed PERIOD

No excuse to withhold the data to the public because of further analyses, or confirmation analyses, or data mining to find other silver lining

Even afterwards the fate of the trial now deemed failure may reverse course (yes there is chance there), it doesn't change the trial failed initially according to its SAP

Thus the company must release the news to the general public even if ultimately the trial would be saved and regained chance of approval.

It's two different things. First you must disclose trial failed in terms of its primary endpoint not meeting predefined metric, and later you also must disclose the trial still has chance of showing both safety and efficacy derived not from its primary endpoint meeting its predefined goal, but from other supporting and persuasive data.

There will be no leeway; otherwise it will become the Old West.

Bottomline: this is a moot point, because the trial is highly likely to meet its primary endpoint in a statistically significant way, hereby the trial will be a success!