Thursday, September 01, 2022 7:53:55 PM
abew, IIRC my understanding is if the trial was a failure that would be an adverse material event and they would have to report it.
"Form 8-K filing deadline for most items to four business days after the occurrence of an event triggering the disclosure requirements of the form."
https://www.sec.gov/rules/final/33-8400.htm
If the trial was not negative, I think the SEC does not have a reporting time limit. IIRC This has been discussed here before, anyone correct me if I'm wrong.
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The following discussion is intended to help guide companies in making clinical trial-related disclosures. Some key takeaways:
Clinical trial data should be disclosed accurately with concise statements.
Companies should plan out disclosures and plan for worst case scenarios well in advance of receipt of clinical trial data.
All disclosures should be reviewed with legal counsel (both SEC and FDA counsel) and all interested internal teams.
Disclosure should not front run the FDA and should not try to manipulate discussions with the FDA to put things in a better light.
Statements should include proper qualifications so investors can make their own informed investment decision about the significance (or lack thereof) of the applicable data.
Disclosures relating to interim results require heightened scrutiny and planning to ensure later disclosures do not contradict prior disclosures or otherwise require a “mea culpa”.
https://www.jdsupra.com/legalnews/managing-and-maintaining-clinical-trial-20887/
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