ASCO-sponsored and Co-sponsored Meetings Guidance for SEC Exception to Data Confidentiality
A research study is not eligible for inclusion in an ASCO sponsored or co-sponsored meeting (“ASCO Meeting”) if the data has been released publicly in a manner that does not comply with ASCO’s confidentiality policy.1 Under this policy, data and other information in a research abstract is confidential from the time the abstract is submitted for the ASCO Meeting until its public release by ASCO in conjunction with the ASCO Meeting.2
Occasionally a publicly traded company is advised that it is legally required to disclose certain data or other information from a confidential abstract in advance of the public release date 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”). Generally this need arises when there is a substantial likelihood that the information would be considered by a reasonable investor in the company to have significantly altered the total mix of information made available to the investor.
In these cases, the abstract is still eligible for inclusion in the ASCO Meeting provided that the company submits to ASCO, in advance of the release:
1. Written notification of the time and manner of the company’s release, with a copy directed to the lead author of the abstract; and
2. 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.
This SEC Exception is self-executing and does not require preapproval from ASCO. To the extent that the SEC Exception applies, the abstract will not be rejected or removed from the ASCO Meeting on the basis of the release of data or other information. However, in the interest of effective peer-reviewed presentation of data at the Annual Meeting, ASCO retains the right in its discretion to change the position of the abstract in the ASCO Meeting, e.g., from oral presentation to poster.
Partners of the company may, jointly or separately, issue a press release with the same information. The abstract itself may not be released publicly by a company or lead author, as ASCO holds the copyright to the abstract.
If data or other information from the abstract is released publicly in a manner that does not qualify for the SEC Exception, ASCO, in its discretion, retains the right to reject or remove the abstract from the ASCO Meeting in accordance with the ASCO confidentiality policy described in the first paragraph of this Guidance.3
ASCO will not review or comment on press releases prepared under the SEC Exception. However, in the interest of effective peer-reviewed presentation of the data at the ASCO Meeting, ASCO would prefer that the company’s press release:
(a) summarize study data cited in the abstract in a qualitative fashion rather than providing specific quantitative information;
(b) avoid interpretations about the implications of the data for practice; and
(c) note that full data has been submitted to the ASCO Meeting.
For companies’ convenience, an example of a press release meeting these criteria is available below. A company’s press release may vary from the example depending on the circumstances.
Example Press Release
1For previously published or presented abstracts submitted to the Breast Cancer Symposium, Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, and Prostate Cancer Symposium, the confidentiality policy applies to new or updated data or information in the study.
2Most abstracts will be publicly available online at www.asco.org approximately two weeks before the Annual Meeting, with plenary, late-breaking, and clinical review abstracts becoming publicly available during the Annual Meeting outside of market hours. Abstracts in the Breast Cancer Symposium, Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, and Prostate Cancer Symposium will be publicly available online at www.asco.org on or just before the opening day of the symposium. Exact posting dates and times will vary from year to year. Press releases issued at or after ASCO’s public release do not violate ASCO policies.
3In rare circumstances, ASCO may grant an exception based on the requirements of another government agency or on public health grounds.