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SEC-Related Issues
If a publicly traded company is advised that it is legally required to disclose certain data or other information from a confidential AAIC abstract in advance of the AAIC news embargo to satisfy requirements of the U.S. Securities and Exchange Commission or a corresponding regulatory body in a country where the company’s stock is traded (collectively, “SEC”), that company must submit to AAIC, in advance of the SEC-required disclosure:
•Written notification of the time, manner and recipients of the company’s release; and
•A letter signed by the company’s legal counsel, advising that (a) public disclosure of the information is necessary for the company to comply with applicable securities laws, and (b) the information disclosed is the minimum necessary for such compliance.
If this is done, the abstract will not be automatically rejected or removed from AAIC on the basis of the SEC-required release of data or other information, though the situation is still subject to AAIC review. At a minimum, AAIC may in its discretion change the position of the abstract in AAIC, e.g., from oral presentation to the poster. The abstract will most likely be ineligible for the AAIC news program.
The company may issue a news release at the time of SEC-required disclosure. The AAIC abstract itself may not be released publicly by the company or lead author. Mention may be made that full details will be presented at AAIC. AAIC would prefer that the news release:
•Summarize study data cited in the abstract in a qualitative rather than quantitative manner.
•Avoid interpretations about the implications of the data for practice.
As an example, a statement that a study “met its primary endpoint of improving cognition” is qualitative, while “ADAS-Cog scores remained stable for 18 months in the treated group” would be considered quantitative. A quote such as “We are encouraged by these promising results” would not be viewed as interpretive, while a quote such as “These findings support [drug] as first-line therapy in mild to moderate Alzheimer’s” would be seen as an interpretation of the data.
