Public float: Unknown (no public float found in SEC filings).
The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
Program / event
Stated period and SEC wording
Disclosure in stated period
KETAFREE (preservative-free ketamine)Other
November 10, 2026
“The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.”
The stated period has not started yet, so there is nothing to compare.
KETAFREE (preservative-free ketamine)Other
summer 2026
“The KETAFREE™ ANDA was refiled in September 2025, and the Company received a letter in November 2025 with a notice that FDA had received the file and assigning a summer 2026 decision date under the Generic Drug User Fee Act (GDUFA).”
ORION has no confirmed start and end dates for this wording, so it is not compared with filings.
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Related companies
Grouped by stated month; each company’s exact timing wording stays on its own page.
Exact dates stated in SEC filings appear as single all-day entries with the company’s sentence as written and its SEC link. Periods and date bounds remain in the company records and are not added to calendars. An entry is updated when the company’s timing wording changes; if newer wording gives no exact date, the entry is removed.
Google Calendar: on a computer, open Google Calendar, then Settings, Add calendar, From URL. Paste the calendar address and choose Add calendar. The phone apps cannot add a calendar by address. Google refreshes subscribed calendars on its own schedule, which can take a day or more.
Apple Calendar on a Mac: choose File, then New Calendar Subscription, and paste the address. Set Location to iCloud to see it on iPhone, and pick an Auto-refresh interval. On iPhone or iPad with iOS 18 or later: Settings, Apps, Calendar, Calendar Accounts, Add Account, Other, Add Subscribed Calendar. On iOS 17 or earlier: Settings, Calendar, Accounts, Add Account, Other, Add Subscribed Calendar.
Outlook on the web or the new Outlook: choose Add calendar, then Subscribe from web, paste the address, name it and choose Import. Classic Outlook for Windows: Home, Add Calendar, From Internet, then paste the address.
Entries are single all-day items on exact dates the company named and are marked as free time. The download link saves a copy that does not update; use the address for a subscription.
No sign-up and no email address. Links back to ORION carry ?src=ics or ?src=rss and nothing else.
Request another SEC timing statement
Suggest an SEC timing statement to add for NRXP. You can include the original filing link in your note. The founder reads each request by hand.
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.