Pharmaceutical regulatory filing citing a New England Journal of Medicine paper — Phasebio Pharmaceuticals, 2019-05-09
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 way it wrote the paper and the actual scope the paper demonstrated, in order. 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 wrote the paper in the press release like this
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 2019-05-09 were 2.02 Earnings Release · 7.01 Reg FD Disclosure · 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 look at first is where the company placed the paper in the press release. Next, they 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 reads only the abstract, cannot answer that.
The scope of the paper discussed in the abstract is limited to this extent.
The paper 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' affiliations are Brigham and Women's Hospital · Harvard University · Thrombosis and Atherosclerosis Research Institute · Thomas Jefferson University. The summary published at the beginning of the paper is called Abstract. What this article has read is only up to there. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract through numerical comparison, so it is a different grade from a full-text reading and a definitive judgment.
This clinical trial in healthy volunteers tested the antibody PB2452 to rapidly reverse the effects of ticagrelor, a drug that prevents blood clotting. The rationale is that ticagrelor's effects cannot be reversed by blood transfusion, making an antidote necessary for emergency surgery or bleeding. Sixty-four volunteers were divided into real drug and placebo groups, given ticagrelor for two days, and then tested for how much platelet function returned through various tests. The effect returned within five minutes of infusion and remained for over twenty hours. Since this was in healthy individuals, the effectiveness in actual bleeding patients is outside the scope of this paper.
Unanswered questions remain in the full text and appendices. This article leaves gaps as gaps. Readers must compare the two citations above to determine which sentence in the abstract the company's citation corresponds to.
One month later, the stock price was within the middle half of the sample.
The portion of returns not explained by market movement is called excess return. Dates are counted as trading days, counting only days when the stock market is open. In calendar terms, twenty trading days is roughly one month. The excess return for the day of the regulatory filing and the following month are shown in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | +0.4% | The extent of movement before the filing |
| On the filing date | +0.0% | On the filing date or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | −18.0% | One week |
| Cumulative over +1 to +20 trading days | −14.4% | 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 -14.4% in this case is within the bottom 37% 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% | −14.4% |
Half of the sample falls between the two central marks on the chart. One checks the chart to see whether this case lies within or outside the range. The sample collects cases where U.S. listed companies cited papers in 8-K filings over the past ten years. The company itself is excluded from the sample. The numbers listed here are historical facts, not rules applicable to future cases.
There is one additional case where the same company cited a paper in an 8-K, and it is included in the table below.
| Disclosure date | Journal of the cited paper | Excess return over one month |
|---|---|---|
| 2019-04-10 | New England Journal of Medicine | +6.4% |
Documents issued by the company after the disclosure
After the disclosure date, the company issued three 8-K filings. Only the item numbers are listed. In 8-K filings without titles, the item number indicates the type of content. Whether it was an earnings announcement or a contract can be identified by the number. The specific event is read in the original text of each link.
- 2019-05-13 8-K Item 5.07 — Results of Shareholder Meeting
- 2019-06-17 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
- 2019-07-01 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 how the paper reviewed what methods, what it re-examined, and how far it showed. How many times the paper cited by the company was cited afterward can be rechecked 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.
Explanation of terms
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. The type is indicated by item numbers such as performance, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder obtained by subtracting the market's overall return from the stock's return. It is used to observe the movement unique to the company by removing the portion attributable to the market's collective rise or fall.
- Trading day
- A count of days when the stock market is open. Weekends and holidays are excluded, so 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
- 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, the details and limitations of the method cannot be known.