Replies to post #165059 on NorthWest Biotherapeutics Inc (NWBO)

[Rootjim]

Yes a publication cannot predict a FDA approval. Perhaps I should have clarified more what I was trying to say. I recently noticed another stock 8-K that their publication has been accepted to be published. I would think that NWBO would be able to 8-K shareholders that their manuscript has been accepted for publication. They could update the Journal name and publication date, when allowed to do so. IMO

[Virgilio]

that’s not what 8-K’s are supposed to be used to communicate

What should 8-k's communicate?

[anders2211]

You are very wrong.

1) The Supreme Court has held that the materiality element is satisfied
when there is "a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the 'total mix' of information made available."

=> a failed trial (proven by peer review is such).

2) In the context of pharmaceutical companies, where a drug or device company “has reached a conclusion that test results on a new product are negative, it may, as a practical matter, be difficult to provide any progress report on the product to the investment community that fails to include this ‘bad’ news without the report being arguably incomplete or misleading

3) Thus, an information-and especially such information in the context of a clinical trial-is material information related to the overall safety profile of the drug, as a whole.

(W.D. Va. Filed May 7, 2012) (requiring Abbott Labs to accept certain facts as true as part of a criminal misbranding plea deal, including failing to disclose material safety and efficacy limitations of Depakote learned through internal clinical studies, during product promotion to doctors).

4) The materiality of a
triggering event will be determined by the facts and circumstances
surrounding the event, including the size of the company, the nature of the business, or the customs of the industry; generally, however, SEC considers material “matters about which an average prudent investor ought to be reasonably informed.”66
In the pharmaceutical companies context, the
announcement of a positive business development, such as FDA approval of
a new drug, or of a negative business development, such as a recall of an existing product or the denial of FDA approval for a new drug, should be reported on a Form 8-K.67

=> if the peer view proves the trial failed that would be therefore material for reasons of safety and for financial reasons
source: https://files.arnoldporter.com/predictablemateriality.pdf