Electronic medical device regulatory filing citing Cephalalgia paper — Electrocore, 2019-09-25
ElectrocoreElectrocoreNASDAQ ECOR
Filings SEC · Quote Yahoo cited a paper published in Cephalalgia 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 manner in which it wrote the paper and the actual scope of the paper in sequence. It noted where the stock price movement over the following month compared to past cases of the same type. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper in the press release like this
When a U.S. listed company has something to inform shareholders, the form it files with the Securities and Exchange Commission is called 8-K. Electrocore filed this document on 2019-09-25, with item numbers 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Cephalalgia in the attached press release. Translating the sentence in the original document that cites the paper verbatim, it reads as follows.
The data submitted in the 510(k) include the results of the Premium 1 study, a randomized, double-blind, sham-controlled trial of gammaCore ™ recently published in the journal Cephalalgia ( https://journals.sagepub.com/doi/pdf/10.1177/0333102419876920 ).
What readers should look at first is where the company placed the paper in the press release. Next, they should determine whether the paper supports the company's entire claim or only part of it. To answer the latter question, one must read the full paper. This article, which only read the abstract, cannot provide an answer.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial and it was published in Cephalalgia on 2019-09-15. The authors' affiliations are University of Duisburg-Essen · King's College London · Wellcome Trust · University of Copenhagen. The summary at the beginning of the paper is called abstract. This article only read up to there. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract by numerical comparison, so it is a different grade from a full-text reading and original judgment.
It is a multi-center trial of a non-invasive vagus nerve stimulator applied to the neck, used three times a day in patients with episodic migraine. After a four-week observation period, participants were divided into real and sham stimulation groups for 12 weeks, followed by 24 weeks of real stimulation for all. 477 people were enrolled, and 332 were analyzed. The real group showed slightly greater reduction in monthly migraine days, but the difference was not statistically significant. The result of this paper is that the trial did not meet its primary endpoint.
The abstract does not answer; the details remain in the main text and the appendix. This article, which does not go there, leaves the blank as it is. Readers compare the two citations above to determine which sentence in the abstract corresponds to the excerpt cited by the company.
One month later, the stock price was within the middle half of the sample.
The return excluding the portion attributable to market-wide movements is called excess return. The dates are recorded as trading days, counting only the days the stock market is open. In terms of the calendar, 20 trading days are approximately one month. The excess return for the day of the regulatory filing and the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −11.5% | The extent to which the stock had already moved before the filing |
| regulatory filing day | −23.9% | filing day or the first trading day thereafter |
| +1~+5 trading day cumulative | −42.4% | one week |
| +1~+20 trading day cumulative | −11.8% | 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 -11.8% in this case is within the bottom 42% 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% | −6.9% | +5.5% | +19.5% | −11.8% |
Half of the sample falls between the two middle marks in the table. Check the table to see whether this case falls inside or outside of that range. The sample consists of cases where U.S. listed companies cited papers in 8-K filings over the past decade. The company itself is excluded from the sample. The numbers listed here are historical facts, not rules to apply to future cases.
After the filing, the company submitted these documents.
After the filing date, the company submitted three 8-K filings. Only the item numbers are listed here. In 8-K filings without titles, the item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be determined by the number. The specific event is read in the original text of each link.
- 2019-10-02 8-K Items 5.02,8.01,9.01 — Officer and Director Changes · Other Events · Financial Statements and Exhibits
- 2019-11-13 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
- 2019-11-20 8-K Item 7.01, 9.01 — Reg FD Disclosure · Financial Statements · Exhibits
What this article does not answer
This article, which only reads abstracts, cannot answer how the paper was conducted, what it reviewed, or how far it went. How many times the paper cited by the company was cited afterward can be rechecked through the citation count on OpenAlexOpenAlex
Data source · Website. The next thing to look at is whether the company's next 8-K filing again cites the same paper.
Term Explanation
- 8-K
- A periodic report submitted to the Securities and Exchange Commission when a listed company in the United States has something to inform its shareholders. The type is indicated by item numbers such as performance, contracts, and executive changes. All events in this article are derived from this document.
- Excess return
- The remainder obtained by subtracting the overall market return from the stock return. It is used to observe the movement of the company itself by removing the portion where the market as a whole rises or falls.
- Trading day
- A date counted only when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to about a month on the calendar.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary appearing 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 and limitations of the methods.