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Replies to post #337446 on NorthWest Biotherapeutics Inc (NWBO)
anders2211
12/09/20 4:30 AM
#337450 RE: biosectinvestor #337446
The rule is a regulation. The SEC enforces its own regulations.
Statements made by life sciences companies are closely scrutinized by the Securities and Exchange Commission (“SEC”) and Department of Justice (“DOJ”).
Pharmaceutical companies and medical device companies frequently must determine what (if anything) to communicate to investors about key developments in clinical trials or the Food and Drug Administration’s (“FDA’s”) regulatory review process. This decision is often complicated because a disclosure may be required even in instances where a company has incomplete information. A life sciences company may, for example, be uncertain about the status of the FDA’s regulatory review, have partial results from a pivotal clinical trial, or have reports of serious adverse events in the absence of confirmatory evidence. In these situations, a company may conclude it has to say something to investors. Determining what to say, however, requires great nuance to ensure that meaningful information is relayed while clearly describing the limits of the company’s knowledge.