Pharmaceutical filing citing the Neurodegenerative Disease Management paper — Biovie, 2021-08-05
BiovieBiovieNASDAQ BIVI
Filings SEC · Quote Yahoo cited a paper published in Neurodegenerative Disease Management in its 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 manner in which it wrote the paper and the actual scope the paper demonstrated in sequence. It described 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 Biovie on 2021-08-05 was 7.01 Reg FD Public · 9.01 Financial Statements·Attached Documents. The company cited a paper published in Neurodegenerative Disease Management in the attached press release. If the sentence citing the paper is translated verbatim, it reads as follows.
The mechanistic basis for the study design was recently published in a peer-reviewed article in Neurodegenerative Disease Management ( https://doi.org/10.2217/nmt-2021-0022 ).
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 part of it. To answer the latter question, one must read the full paper. This article, which only read the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is up to this point.
The title of the paper is NM101 Phase III Study of NE3107 in Alzheimer’s Disease: rationale, Design and Therapeutic Modulation of Neuroinflammation and Insulin Resistance and it was published in Neurodegenerative Disease Management on 2021-07-12. The authors' affiliations are AbbVie (United States) · Worldwide Clinical Trials (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 a different grade from a full-text reading and original judgment.
This paper is not a report on results but an explanation of the design of a future phase 3 clinical trial. It introduces previous results showing that the oral drug NE3107 selectively blocks inflammatory signals based on the background that inflammation and insulin resistance are involved in neurodegeneration. The plan is to randomly divide 316 patients with mild to moderate Alzheimer's disease into halves and compare the drug and placebo for 30 weeks, using cognitive function and daily function as two primary indicators. Since this is a design paper, it is not possible to know whether the drug is effective from this article.
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 in the bottom quarter of the sample.
The return remaining after subtracting the portion that moves with the entire market is called excess return. The date is written as trading day, counting only the days when the stock market is open. In terms of a calendar, 20 trading days are about a month. The regulatory filing day in this case and the excess return for the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | −15.2% | The extent to which it had already moved before the filing |
| regulatory filing day | +2.8% | filing day or the first trading day thereafter |
| cumulative +1~+5 trading days | −43.9% | one week |
| cumulative +1~+20 trading days | −52.3% | 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 -52.3% in this case is in the bottom quarter, corresponding to the 2% 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 | −31.8% | −20.1% | −6.9% | +5.5% | +19.5% | −52.3% |
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 determined by the number. The details of what occurred are read in the original text via each link.
- 2021-08-11 8-K Items 1.01,7.01,8.01,9.01 — Material contract execution · Reg FD disclosure · Other events · Financial statements and exhibits
- 2021-10-14 8-K Item 5.07 — Results of shareholder meeting
- 2021-12-01 8-K Items 1.01,2.03,3.02,7.01,9.01 — Material contract execution · Debt issuance · Unregistered securities sale · Reg FD disclosure · Financial statements and exhibits
What this article does not answer
This article, which reads only abstracts, cannot answer what method the paper used to investigate what and up to what extent. How many times the paper cited by the company has been cited afterward can be verified again via the citation count on OpenAlexOpenAlex
Data source · Website. The next thing to look at is whether the company's next 8-K again cites the same paper.
Term Explanation
- 8-K
- A periodic report submitted to the Securities and Exchange Commission when a listed company in the United States has something to inform its shareholders. The type is indicated by item numbers such as performance, 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 where the market as a whole rises or falls.
- Trading day
- A date counted only on days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to about a 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 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 methods.