Pharmaceutical filing citing a New England Journal of Medicine paper — Phasebio Pharmaceuticals, 2019-04-10
Phasebio PharmaceuticalsPhasebio PharmaceuticalsUS PHASQ
cited a paper published in the New England Journal of Medicine 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 the paper demonstrated, in sequence. The stock price movement over one month following the filing was compared to past cases of the same type, and the result was written as a hindsight judgment after knowing the outcome. The paper was read only up to the abstract.
The disclosure was written in the press release as follows:
When a U.S. listed company has something to inform its shareholders, the form it files with the Securities and Exchange Commission is called 8-K. The item numbers of the document filed by Phasebio Pharmaceuticals on 2019-04-10 were 7.01 Reg FD disclosure · 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in New England Journal of Medicine in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Antibody-based ticagrelor reversal agent in healthy volunteers. N.
What readers should first check 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 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.
The scope of the paper discussed in the abstract is limited to this.
The paper's title is Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers and it was published in New England Journal of Medicine on 2019-03-17. The authors are affiliated with Brigham and Women's Hospital · Harvard University · Thrombosis and Atherosclerosis Research Institute · Thomas Jefferson University. The summary at the beginning of the paper is called abstract. What this article has read is only up to this point. This paragraph was written by a person after filtering a draft written by a machine reading the abstract by numerical comparison, and thus it is of a different grade from a full-text reading and original judgment.
This is a clinical trial of a healthy volunteer testing an antibody that rapidly restores the effects of ticagrelor, a drug that prevents blood clotting. The background is that the drug's effects cannot be reversed by blood transfusion, so an antidote is needed for emergency surgery or bleeding. Sixty-four volunteers were divided into real drug and placebo groups, and after taking ticagrelor for two days, their platelet function recovery was measured through various tests. The effect returned within five minutes of injection and was maintained for over twenty hours. Since it was tested on healthy individuals, the effectiveness in actual bleeding patients is outside the scope of this paper.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves the blanks as they are. Readers should determine themselves which sentence in the abstract corresponds to the cited section cited by the company, by comparing the two citations above.
One month later, the stock price was within the upper quartile 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 trading day, counting only the days the stock market is open. In calendar terms, 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 | +22.3% | The extent of movement before the filing |
| On the day of the filing | −12.6% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | −1.4% | One week |
| Cumulative +1~+20 trading days | +6.4% | 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 +6.4% in this case is within the top quarter, corresponding to the 76% position from the bottom among 142 samples.
| 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% | +6.4% |
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 applicable to the next case.
There is one additional case where the same company wrote a paper in 8-K, so it is placed together in the table below.
| Disclosure date | the journal of the paper | excess return of one month |
|---|---|---|
| 2019-05-09 | New England Journal of Medicine | −14.4% |
after the filing, the company issued such documents
after the filing date, the company issued 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 identified by the number. The details of what occurred are read in the original text of each link.
- 2019-05-09 8-K Items 2.02, 7.01, 9.01 — Earnings announcement · Reg FD disclosure · Financial statements · Attached documents
- 2019-05-13 8-K Item 5.07 — Results of the Shareholders' Meeting
- 2019-06-17 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
What this article does not answer
This article, which reads only abstracts, cannot answer what the paper reviewed, how it was done, or how far it went. How many times the paper cited by the company was cited afterward can be checked again through the citation count on OpenAlexOpenAlex
Data source · Website. What will be seen next is whether the company's next 8-K 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 earnings, contracts, and executive changes. All the 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 alone after removing the portion where the market as a whole rises or falls.
- Trading day
- A date counted only on 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 is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary 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 and limitations of the methods.