Response to the Discussion of "The Effect on Financial Reporting Quality of an Exemption From the SEC Reporting Requirements for Foreign Private Issuers"

We appreciate the thorough discussion provided by Professor Yuan Ding. His comments raise legitimate issues. In this response, we offer clarifications and suggest avenues for future research. Our response follows the structure of the discussant’s paper and elaborates on each point separately.

The Effect on Financial Reporting Quality of an Exemption From the SEC Reporting Requirements for Foreign Private Issuers

We test for differences in financial reporting quality between companies that are required to file periodically with the SEC and those that are exempted from filing reports with the SEC under Rule 12g3-2(b). We examine three earnings quality measures: conservatism, abnormal accruals, and the predictability of earnings. Our results, for all three measures, show different financial reporting quality for companies that file with the SEC than for companies exempt from filing requirements. This paper provides empirical evidence of a link between filing with the SEC and financial reporting quality for foreign firms.

Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial

Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpatient based. We aimed to assess non-inferiority of outpatient care compared with inpatient care.

Off-label use of misoprostol for labor induction: a nation-wide survey in Switzerland

Off-label use of drugs is frequent in obstetrical practice. No data however are available about nation-wide off-label use in obstetrics regarding frequency and patient information. The objective of our study was to assess the clinical practice of off-label use of misoprostol for labor induction.

Current state of evidence on 'off-label' therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland--a consensus report

Systemic lupus erythematosus (SLE) can be a severe and potentially life-threatening disease that often represents a therapeutic challenge because of its heterogeneous organ manifestations. Only glucocorticoids, chloroquine and hydroxychloroquine, azathioprine, cyclophosphamide and very recently belimumab have been approved for SLE therapy in Germany, Austria and Switzerland. Dependence on glucocorticoids and resistance to the approved therapeutic agents, as well as substantial toxicity, are frequent. Therefore, treatment considerations will include 'off-label' use of medication approved for other indications. In this consensus approach, an effort has been undertaken to delineate the limits of the current evidence on therapeutic options for SLE organ disease, and to agree on common practice. This has been based on the best available evidence obtained by a rigorous literature review and the authors' own experience with available drugs derived under very similar health care conditions. Preparation of this consensus document included an initial meeting to agree upon the core agenda, a systematic literature review with subsequent formulation of a consensus and determination of the evidence level followed by collecting the level of agreement from the panel members. In addition to overarching principles, the panel have focused on the treatment of major SLE organ manifestations (lupus nephritis, arthritis, lung disease, neuropsychiatric and haematological manifestations, antiphospholipid syndrome and serositis). This consensus report is intended to support clinicians involved in the care of patients with difficult courses of SLE not responding to standard therapies by providing up-to-date information on the best available evidence.

Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial

Non-nephrotoxic immunosuppressive strategies that allow reduction of calcineurin-inhibitor exposure without compromising safety or efficacy remain a goal in kidney transplantation. Immunosuppression based on the mammalian-target-of-rapamycin inhibitor everolimus was assessed as a strategy for elimination of calcineurin-inhibitor exposure and optimisation of renal-graft function while maintaining efficacy.

A New Symbiosis: Municipalities, Private Contractors and Non-Governmental Organisations for the Provision of Local Public Services"

This project considered the second stage of transforming local administration and public service management to reflect democratic forms of government. In Hungary in the second half of the 1990s more and more public functions delegated to local governments have been handed over to the private or civil sectors. This has led to a relative decrease of municipal functions but not of local governments' responsibilities, requiring them to change their orientation and approach to their work so as to be effective in their new roles of managing these processes rather than traditional bureaucratic administration. Horvath analysed the Anglo-Saxon, French and German models of self-government, identifying the differing aspects emphasised in increasing the private sector's role in the provision of public services, and the influence that this process has on the system of public administration. He then highlighted linkages between actors and local governments in Hungary, concluding that the next necessary step is to develop institutional mechanisms, financial incentives and managerial practices to utilise the full potential of this process. Equally important is the need for conscious avoidance of restrictive barriers and unintended consequences, and for local governments to confront the social conflicts that have emerged in parallel with privatisation. A further aspect considered was a widening of the role of functional governance at local level in the field of human services. A number of different special purpose bodies have been set up in Hungary, but the results of their work are unclear and Horvath feels that this institutionalisation of symbiosis is not the right path in Hungary today. He believes that the change from local government to local governance will require the formulation of specific public policy, the relevance of which can be proven by processes supported with actions.

Private Publishing in Moscow and St. Petersburg: Historical Background, Present Situation and Trends"

This research was a complex study of the economic and socio-cultural aspects of the development of Russian private publishing in the second half of the19th and early 20th centuries, during the periods of 'war communism' and the New Economic Policy of 1917 to 1930, and during the reform of book publishing in 1986-1999. Conclusions about private book publishing in Moscow and St. Petersburg were extrapolated to Russia-wide problems of the development of this field. Svichenskaya sees her main achievement as having identified the economic and legal concepts behind the development of private book publishing over the period in question in the context of state and corporate regulation of publishing. Here the state was the main influence on its development and there was a paradox in the relations between the state authorities and private publishers, in that the latter constantly suffered from repression by the former but at the same time were dependent on state support. The research identified the administrative process of the liquidation of private publishing at the end of the 1920s and showed that its present flourishing is closely linked with the establishment of a preferential mode for the development of this sector. Private publishing now represents around 80% of domestic publishing, in terms both of the number of publishing houses and of the number of volumes published, and so plays the major role in satisfying the demand for books in Russia. Svichenskaya predicts that in the coming years private publishing will see a further concentration of growth and a tendency to monopolies and also the increasing specialisation of the publishing repertoire. She outlines a suggested concept of state management in publishing and ways to optimise this. In the transitional period of adaptation to the market regulation of publishing, these include a continuing degree of state protectionism, the creation of a favourable investment climate, privatisation of the printing companies with the aim of modernising these, and the development of coordinated corporate policies.

Public, Private and University Collaboration: Applying a Retrospective Study of the Central Massachusetts Bio-Medical Cluster, Cluster Project Summary for Mosakowski Institute

Three Clark faculty members are studying the development of the Worcester Biotechnology Cluster for any lessons it might hold for current efforts to catalyze the growth of a sustainable energy/green jobs cluster in Worcester or elsewhere. Mary Ellen Boyle (GSOM), Jennie Stephens (IDCE/ESP), and Jing Zhang (GSOM) have conducted extensive in-depth interviews and combed the literature of cluster development to produce several articles and working papers.