Pharmaceutical filing citing a Journal of Allergy and Clinical Immunology paper — Optinose, 2018-06-21
OptinoseOptinoseUS OPTN
cited a paper published in the Journal of Allergy and Clinical Immunology as a basis for its claims in a regulatory filing submitted to the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the way it wrote the paper and the scope the paper actually showed in sequence. It noted where the stock price movement over the following month compared to past cases of the same type. This is a hindsight judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper like this in the press release
When a U.S. listed company has something to inform shareholders, it files a continuing report with the Securities and Exchange Commission, called 8-K. The item numbers in the document filed by Optinose on 2018-06-21 were 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Journal of Allergy and Clinical Immunology in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows:
References 1 - Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA, NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis , Journal of Allergy and Clinical Immunology (2018), doi:10.1016/j.jaci.2018.06.010. 2 - Palmer JN, Jacobsen KW, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA.
What the reader should first check is where the company placed the paper in the press release. Next, the reader should determine whether the paper supports the entire company claim or only a part of it. To answer the latter question, one must read the full paper. This article, which has only read the abstract, cannot provide an answer to that.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis and it was published in Journal of Allergy and Clinical Immunology on 2018-06-19. The authors are affiliated with University of Vermont · OptiNose (United States) · OptiNose (Norway). The summary at the beginning of the paper is called abstract. This article has only read up to this point. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract through numerical comparison, and thus it is of a different grade from a full-text reading and original judgment.
This study is a clinical trial targeting patients with chronic rhinosinusitis and nasal polyps. It evaluated the use of fluticasone via an inhalation delivery system in 323 patients over 24 weeks. The primary outcome measures, improvement in nasal congestion and nasal polyp scores, were both significantly improved in the experimental group. However, the study did not address long-term treatment effects or comparisons with other treatments.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves the gaps as they are. Readers should compare the two citations above to determine which sentence in the abstract corresponds to the citation provided by the company.
One month later, the stock price was within the middle half of the sample.
The remaining return, after subtracting the portion that moves with the overall market, is called excess return. The date is written as a trading day, counting only the days the stock market is open. In terms of a calendar, 20 trading days are approximately one month. The excess return for the day of the regulatory filing and the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | +11.4% | The extent of movement before the filing |
| On the day of the filing | −0.4% | On the filing day or the first trading day after |
| Accumulated over +1 to +5 trading days | +14.4% | One week |
| +1 to +20 trading days cumulative | −3.7% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed as a percentile. The one-month excess return of -3.7% in this case is within the bottom 58% of the 142 samples, placing it in the lower half.
| Sample scale (20 trading days) | Tenth from the bottom | Fourth from the bottom | median | top 25% | top 10% | This case |
|---|---|---|---|---|---|---|
| Excess return | −31.9% | −20.1% | −7.4% | +5.5% | +19.5% | −3.7% |
Half of the sample falls between the two central marks in the chart. One checks from the chart whether this case lies inside or outside. The sample collects cases where U.S. listed companies wrote papers in 8-K over the past ten years. The company itself is excluded from the sample. The numbers written here are past facts, not rules to apply to the next case.
After the regulatory filing, the company issued such documents
After the filing date, the company issued three 8-K filings, listed only by item numbers. In 8-K filings without titles, the item number indicates the type of content. One can determine whether it was an earnings announcement or a contract based on that number. What exactly occurred is read in the original text of each link.
- 2018-07-11 8-K Item 8.01 — Other Events
- 2018-08-14 8-K Items 2.02,8.01,9.01 — Earnings announcement · Other events · Financial Statements·Exhibits
- 2018-10-01 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
What this article does not answer
This article, which reads only the abstract, does not answer what the paper re-examined, how, or to what extent. How many times the paper cited by the company was cited afterward can be verified again through the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K again cites the same paper.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. It is categorized by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to observe the movement of the company alone by removing the portion where the market as a whole rises or falls.
- Trading day
- A date counting only the days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to approximately one calendar month.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom within it is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- An abstract is placed at the beginning of a paper. The author writes in a few sentences what was done, how it was done, and what results were obtained. Without reading the full text, one cannot know the details or limitations of the methods.