Pharmaceutical regulatory filing citing Advances in Therapy paper — Praxis Precision Medicines, 2022-11-28
Praxis Precision MedicinesPraxis Precision MedicinesNASDAQ PRAX
Filings SEC · Quote Yahoo cited a paper published in Advances in Therapy as the 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 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 report submitted to the Securities and Exchange Commission is called 8-K. The item numbers of the document submitted by Praxis Precision Medicines on 2022-11-28 were 7.01 Reg FD public · 8.01 other events · 9.01 financial statements · attached documents. The company cited a paper published in Advances in Therapy in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
The Hidden Burden of Disease and Treatment Experiences of Patients with Essential Tremor: A Retrospective Claims Data Analysis.
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 reads only the abstract, cannot answer that.
The scope of the paper mentioned in the abstract is up to here.
The title of the paper is The Hidden Burden of Disease and Treatment Experiences of Patients with Essential Tremor: A Retrospective Claims Data Analysis and it was published in Advances in Therapy on 2022-10-14. The authors' affiliations are Praxis (United States) · Precision for Medicine (United States) · University of Kansas Medical Center · Praxis. 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 of a different grade from a full-text reading and a verified reading.
This is an observational study based on insurance claims data to examine how many people in the United States have essential tremor and how they are treated. Patients identified through diagnostic codes numbered 1,300,000, but when extrapolated to the entire U.S. population based on prescriptions or repeated diagnoses, the number was approximately 200,000. Most confirmed patients had other conditions, and fewer than two out of three received medication. Since the data comes from claims, it is not possible to determine the accuracy of the diagnoses or whether the medications were actually taken.
What is not answered in the abstract remains in the full text and appendices. This article leaves gaps as they are. Readers are to determine which sentences in the abstract correspond to the excerpts cited by the company by comparing the two citations above.
One month later, the stock price was in 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 recorded in trading days, counting only the days the stock market is open. In calendar terms, 20 trading days is roughly 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 | −8.1% | The extent of movement before the filing |
| On the filing date | +2.8% | On the filing date or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +9.9% | One week |
| Accumulated over +1 to +20 trading days | +17.0% | 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 +17.0% in this case is within the top quarter, corresponding to the 87% 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% | +17.0% |
Half of the sample falls between the two central marks on the chart. One checks from the chart whether this case is inside or outside. 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 past 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.
| Filing date | Journal of the cited paper | Excess return over one month |
|---|---|---|
| 2022-11-09 | Advances in Therapy | −14.9% |
Documents issued by the company after the filing
Only item numbers are listed for the three 8-K filings issued by the company after the filing date. In 8-K filings without titles, item numbers indicate the type of content. Whether it was an earnings announcement or a contract can be identified by the item number. The specific event is read in the original text of each link.
- 2023-02-07 8-K Item 2.02,7.01,9.01 — Earnings announcement · Reg FD disclosure · Financial statements · Attached documents
- 2023-03-03 8-K Item 7.01, 8.01, 9.01 — Reg FD disclosure · Other events · Financial statements · Exhibits
- 2023-03-10 8-K Item 7.01 — Reg FD Disclosure
What this article does not answer
This article, which reads only abstracts, cannot answer how the paper re-examined what and showed up to where. How many times the paper cited by the company was cited afterward can be rechecked through OpenAlexOpenAlex
Data source · Website citation counts. 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 earnings, 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 company's unique movement after removing the portion attributable to the market's collective rise or fall.
- 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 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 method.