Pharmaceutical filing citing Hernia paper — Heron Therapeutics, 2019-10-02
Heron TherapeuticsHeron TherapeuticsNASDAQ HRTX
Filings SEC · Quote Yahoo cited a paper published in Hernia 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 for one month after the filing was 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 was written in the press release as follows:
When a U.S. listed company has an event to inform shareholders, the form it files with the Securities and Exchange Commission is called 8-K. The item numbers of the document filed by Heron Therapeutics on 2019-10-02 were 7.01 Reg FD Public · 8.01 Other Events · 9.01 Financial Statements and Exhibits. The company cited a paper published in Hernia in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Assumes LOCF as publication does not describe any correction for opioid use Disclaimer This is a cross-study comparison of Study 306 to the PILLAR Study of Exparel plus bupivacaine; these comparisons are not based on head-to-head clinical studies.
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.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study and it was published in Hernia on 2019-08-19. The authors' affiliations are Thomas Jefferson University · CFD Research Corporation (United States) · Anaheim Clinical Trials · UC San Diego Health System. The summary at the beginning of the paper is called abstract. This article has only read up to this point. The paragraph was written by a person after filtering out a draft written by a machine by comparing numbers, so it is of a different grade than a full reading of the paper.
It is a phase 3 trial examining the long-acting local anesthetic HTX-011 in patients undergoing hernia surgery, assessing pain and opioid use for three days after surgery. Four hundred and eight patients were randomly assigned to three groups: HTX-011, the existing bupivacaine, and saline. Neither the patients nor the medical staff knew which group they were in. The primary outcome of pain intensity was significantly lower than the placebo, and all predefined key secondary outcomes also favored HTX-011. Since the result was obtained from one type of surgery, whether it applies to other surgeries is outside the scope of this paper.
What the abstract does not answer remains in the full paper and its appendices. This article, which has not gone beyond the abstract, leaves the blanks as they are. Readers should determine which sentence in the abstract corresponds to the cited excerpts from the company's statements 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 a trading day, counting only days when 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 | −7.5% | The extent of movement before the filing |
| On the day of the filing | +7.3% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +6.0% | One week |
| Cumulative +1~+20 trading days | +9.8% | 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 +9.8% in this case is within the top quarter, corresponding to the 82% 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% | +9.8% |
Half of the sample falls between the two marks in the middle of the table. One checks from the table whether this case is 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 happened is read in the original text of each link.
- 2019-10-08 8-K Item 1.01,9.01 — Material Contract Execution · Financial Statements and Exhibits
- 2019-10-22 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
- 2019-10-28 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 method the paper used, what it reviewed, and how far it went. How many times the paper cited by the company has been cited afterward can be verified again by 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 the stock market is open. Since weekends and holidays are excluded, 20 trading days are 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
- 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.