Electronic medical device filing citing PLoS ONE paper — Soleno Therapeutics, 2019-11-13
Soleno TherapeuticsSoleno TherapeuticsUS SLNO
cited a paper published in PLoS ONE in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website as a basis for its claims. The company read the way it wrote the paper and the actual scope of the paper in order. 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 report submitted to the Securities and Exchange Commission is called 8-K. The item number of the document submitted by Soleno Therapeutics on 2019-11-13 was 2.02 Earnings announcement · 9.01 Financial statements · Attached documents. The company cited a paper published in PLoS ONE in the attached press release. If the sentence citing the paper is copied verbatim, it reads as follows.
The sentence citing the paper in the press release could not be automatically found. Check the original link. Do not replace it with another paragraph.
What readers see first is where the company placed the paper in the press release. Next is determining whether the paper supports the entire company 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 answer that.
The scope of the paper mentioned in the abstract is limited to this extent.
The paper title is A randomized pilot efficacy and safety trial of diazoxide choline controlled-release in patients with Prader-Willi syndrome and it was published in PLoS ONE on 2019-09-23. The authors' affiliations are University of California, Irvine · Loma Linda University · Soleno Therapeutics (United States). The summary published 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 through numerical comparison, so it is of a different grade from a full-text reading and original judgment.
A phase 2 trial at one hospital administered extended-release diazoxide choline capsules to 13 patients with Prader-Willi syndrome, a genetic disorder characterized by constant feelings of hunger. For 10 weeks, all patients received the drug with increasing doses, followed by a four-week placebo-controlled, double-blind comparison. At the end of the open period, the overeating score significantly decreased, with a greater reduction observed in patients with initially severe symptoms and those receiving higher doses. With only 13 patients and a four-week blinded comparison, this trial does not confirm the drug's efficacy.
The parts not answered are left in the specialty and appendix. This article leaves gaps as gaps. Readers are to determine which sentence in the abstract corresponds to the company's cited excerpt by comparing the two citations above.
One month later, the stock price was within the top quarter of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. Dates are counted 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 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 |
|---|---|---|
| Five trading days before the filing | −6.2% | The extent of movement before the filing |
| On the filing date | +10.5% | On the filing date or the first trading day afterward |
| Cumulative over +1 to +5 trading days | +10.9% | One week |
| Cumulative over +1 to +20 trading days | +19.5% | 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 +19.5% in this case is within the top quarter, corresponding to the 90% 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% | +18.7% | +19.5% |
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 decade. The company itself is excluded from the sample. The numbers listed here are historical facts, not rules applicable to future cases.
After the filing, the company issued such documents.
Three 8-K filings issued by the company after the filing date are listed with only item numbers. In 8-K filings without titles, item numbers indicate the type of content. One can determine whether it was an earnings announcement or a contract based on the number. The specific event is read in the original text via each link.
- 2019-11-15 8-K Item 5.02,9.01 — Officer and director changes · Financial statements and exhibits
- 2020-01-06 8-K Item 8.01, 9.01 — Other Events · Financial Statements · Exhibits
- 2020-01-10 8-K Item 7.01, 9.01 — Reg FD Disclosure · Financial Statements · Exhibits
What this article does not answer
This article, based only on abstracts, cannot answer what method the paper used, what it reviewed, or how far it demonstrated. How many times the cited paper was subsequently referenced can be verified again using the citation count from OpenAlexOpenAlex
Data source · Website. What will be examined next is whether the company's next 8-K filing cites the same paper again.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. Types are indicated 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 see the movement of the company alone by removing the part 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 about a month in 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 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 method.