Replies to post #348616 on NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

No. The company is obligated to go public if its trial fails PERIOD.

For example, if the trial's primary endpoint is not met, there will be no doubt to anyone, FDA, or any average investor or to any person with common sense, that the trial fails. As a result the company must/should notify all shareholders in a news release.

Of course, failing in the primary endpoint doesn't mean there is no chance for the agent/treatment of the trial to be ultimately approved by FDA, and the trial may later actually be approved to be successful with persuasive results of efficacy and safety derived from its meeting some secondary endpoints and peripheral testing results such as immunodeficiency of patients, etc, after painstaking efforts and further more detailed analyses and regulatory negotiation, etc.

The above two doesn't contradict one another. Yes the company has the obligation to disclose if its trial fails in terms of the trial's primary endpoint (if that is not defined as failure, then no clearer definition of trial failure ever exists; don't tell me only if the trial fails in both its primary and secondary endpoints can it be defined as failure). And yes, the status of the trial can in the end reverse course and be defined as a success after painstaking efforts and persuasive data analysis support, which can only come in much later time.

Specifically in the case of nwbo, it is more than likely the trial has met its primary endpoint in a statistically significant way, thereby DI's comments to several callers that the company would have notified shareholders if the trial had failed. It in itself doesn't mean DI has been unblinded. However, if he has not, if the trial's primary endpoint is a miss, statisticians must notify the company!

Now, with what we have known (the blinded blended trial results and the subsequent data update) the trial will definitely meet its primary endpoint, not because the standard of the trial is lowered but the fact all other trials, including the FDA approved Novocure device has not yielded better results than DCVax-L trial in terms of safety and efficacy, if the unblinded data is at least as good as the blinded blended data we have known.

IMO from now on, nobody should talk about whether this trial is a failure or not, instead they should talk about how successful this trial will be! Let me repeat what I has said for a month or so:

A price below $2 is a steal!

[biosectinvestor]

Yes.

While the company’s ultimately is obligated to tell and delay creates potential problems that I am sure, from their statements, they’d definitely want to avoid, the obligation is about avoiding liability, not an immediate “regulatory reporting” requirement.

People confuse these things.

I think they would probably have revealed a failure because they have said so from the beginning. But I personally trust management in that point. As an attorney, I think Linda would prefer to avoid lawsuits even if she might have more time.

But that is different than a legal obligation to disclose in 4 days. Generally also, in their regular reporting, they have a duty to not deceive or commit fraud. Not exactly an affirmative duty, but I think they’d probably want to disclose if there were a failure before their 10K is due, which is their next relevant periodic report.

But you’ve described it correctly.

[anders2211]

If from the independent statistician's feedback NWBO management can determine that FDA approval for DCVAX-L for what it was intended for is highly unlikely then that is a material event that should be disclosed within 4 business days. Period.