Embecta Corp
For the period ended Mar 31, 2024. Filed May 9, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 9, 2024
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2023-12-31; filed 2024-02-09.
0001872789-24-000006
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001872789-24-000019
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 3 previous paragraphs and 2 current paragraphs.
1 unchanged; 1 reworded; 0 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Removed paragraphs (1)
Previous report
In the first quarter of Embecta’s fiscal year 2024, Embecta submitted its first 510(k) premarket filing to the FDA for its proprietary disposable insulin delivery system. We cannot predict when, if ever, such submission will be cleared by the FDA, as the FDA can refuse to grant a 510(k) clearance for many reasons, including the system may not be deemed by the FDA to be substantially equivalent to appropriate predicate devices under the 510(k) pathway, the system may not satisfy the FDA’s safety or effectiveness requirements, or changes in FDA clearance policies or adoption of new regulations may require additional data. Even if cleared by the FDA or foreign regulatory agencies, future generations of our systems, expanded indications for use of future systems, our software platforms or any other system under development, may not be cleared for the indications that are necessary or desirable for successful commercialization.
Reworded paragraphs (1)
Previous wording
There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2023 Form 10-K, except for the addition of the following risk factor:
Current wording
There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2023 Form 10-K and Embecta’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2023 filed with the Securities and Exchange Commission on February 9, 2024.