Biological product regulatory filing citing a Journal of the American Academy of Dermatology paper — Fresh Tracks Therapeutics, 2020-03-18
Fresh Tracks TherapeuticsFresh Tracks TherapeuticsUS FRTX
cited a paper published in the Journal of the American Academy of Dermatology 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 scope the paper actually demonstrated in sequence. The stock price movement for one month after the filing was compared to past cases of the same type to determine its position. 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 unscheduled report submitted to the Securities and Exchange Commission is called 8-K. The item number of the document submitted by Fresh Tracks Therapeutics on 2020-03-18 was 2.02 Earnings announcement · 9.01 Financial statements · Attached documents. The company cited a paper published in Journal of the American Academy of Dermatology in the attached press release. Translating the sentence citing the paper verbatim from the original text, it reads as follows.
Additionally, on January 10, 2020, Brickell announced that Kaken submitted a new drug application for approval in Japan of manufacturing and marketing for sofpironium bromide gel for primary axillary hyperhidrosis based on the positive results from this study. • On February 20, 2020, Brickell announced that positive results from its Phase 2b study with sofpironium bromide in patients with primary axillary hyperhidrosis were published in the peer-reviewed Journal of the American Academy of Dermatology (JAAD).
What readers should look at first is where the company placed the paper in the press release. Next, it is necessary to determine whether the paper supports the entire company's claim or only a part of it. To answer the latter question, one must read the full paper. This article, which only read the abstract, cannot answer that.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial and it was published in Journal of the American Academy of Dermatology on 2020-02-14. The authors' affiliations are Clinical Research Institute · University of California, Irvine · Sensory Processing Disorder Foundation · DermResearch (United States). The summary published at the beginning of the paper is called abstract. What this article read was 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 of a different grade from a full-text reading and a verified judgment.
The abstract of this paper is not publicly available, so it was not summarized. What can be known from the title is that it is a clinical trial examining the efficacy and safety of topical chlorhexidine gluconate gel for axillary hyperhidrosis. The number of participants and the duration of the study are in the main text.
The abstract does not answer; it remains in the main text and the appendix. This text, 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.
A month later, the stock price was within the middle half of the sample.
The return excluding the portion attributable to movement with the overall market is called excess return. The date is recorded in 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 on the day of the regulatory filing and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −14.1% | The extent to which it had already moved before the filing |
| regulatory filing day | −1.0% | filing day or first trading day thereafter |
| +1~+5 trading day cumulative | −2.1% | one week |
| +1~+20 trading day cumulative | −19.6% | 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 -19.6% in this case is within the bottom 27% 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% | −19.6% |
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, this 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 identified by the number. The details of what happened are read in the original text through each link.
- 2020-04-03 8-K Item 8.01 — Other Events
- 2020-04-14 8-K Item 1.01,9.01 — Material contract execution · financial statements·attached documents
- 2020-04-20 8-K Item 5.07 — Results of the Shareholders' Meeting
What this article does not answer
This article, which only reads abstracts, cannot answer how the paper reviewed what method, what it re-evaluated, and up to what extent. How many times the paper cited by the company has been cited afterward can be re-verified through the citation count on OpenAlexOpenAlex
Data source · Website. The next thing to look at is whether the company's next 8-K filing cites the same paper again.
Term Explanation
- 8-K
- A periodic report submitted to the U.S. Securities and Exchange Commission when a listed company has something to inform its shareholders. The type is indicated by item numbers such as earnings, 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 attributable to the entire market rising or falling together.
- 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 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.