Amarin Corp Plc (AMRN)

[sts66]

Don't know how you found that, but I agree it's shocking that the companies weren't sued or investigated by the SEC for not releasing what's clearly material info - it doesn't get more material than a CRL! Actually, maybe some were - you'd have to find the 18% who didn't PR the CRL and google them for lawsuits - the paper doesn't give names, and the paper only looked at the time period from 2009-2013, would be tough to find such old news.

Found this article - FDA can't release contents of CRLs, only companies can, and the authors of your BMJ study worked for the FDA so they had access to them - they also say CRLs are material info and SEC requires PR for them:

https://www.agencyiq.com/the-fdas-complete-response-letter-secrecy-could-be-on-a-crash-course-with-covid/

Under current practice, the recipient of a CRL may share the existence of that letter, or even make it public. However, the FDA is not itself permitted to make it publicly available (or at least not without significant redactions).

Public companies must share the existence—but not the content—of CRL letters with shareholders, since the severity of the citation can significantly influence the trajectory of an investment in research, development, testing and manufacturing in the billions. CRLs are a decisional marker and constitute “agency action,” which can affect investor confidence.

The result of this secrecy is that most CRLs are never revealed to the public in any meaningful way. The majority of CRLs remain veiled, depriving the public of potentially useful information.

While certain filings with the SEC are required by law in order to prevent securities fraud, companies maintain the ability to control the public narrative about what the FDA discloses in a CRL. This can often result in a portrayal that is more commercially favorable than it is accurate.

A study of CRLs published in the British Medical Journal compared the full CRLs with press releases by the companies to which the CRLs were issued (the authors, who were FDA staffers, had access to both).