Thursday, July 13, 2023 8:42:35 AM
You're reading it casually too. The sentence only states an intention to submit protocol this week. It doesn't say when the meeting is scheduled or anticipated. Moreover, we've been through this 4X before with RDGL. Meetings follow submissions by several weeks becuase FDA reviewers need time to review the submission beforehand.
This is how a technical writer/reader reads the sentence:
"Next week we will submit the protocol to FDA" OK, writer states an intention or forecast to submit the protocol next week (now this week).
"for review at a Pre-Sub meeting as they recommended." OK, writer states the purpose of the planned submission and that the planned submission is in compliance with an FDA recommendation. Writer is in no way is stating that this meeting has been already scheduled or when it is anticipated.
This is how a technical writer/reader reads the sentence:
"Next week we will submit the protocol to FDA" OK, writer states an intention or forecast to submit the protocol next week (now this week).
"for review at a Pre-Sub meeting as they recommended." OK, writer states the purpose of the planned submission and that the planned submission is in compliance with an FDA recommendation. Writer is in no way is stating that this meeting has been already scheduled or when it is anticipated.
Recent RDGL News
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 03/06/2026 05:15:04 AM
- Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 03/04/2026 04:48:52 PM
- Vivos Inc. Diversifies Manufacturing Base with Planned U.S. and International Production Sites • GlobeNewswire Inc. • 02/17/2026 01:30:00 PM
- Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption (IDE) Submission for RadioGel® Precision Radionuclide Therapy™ • GlobeNewswire Inc. • 02/10/2026 01:30:00 PM
- Vivos Inc Updates Human Therapy Progress in India • GlobeNewswire Inc. • 02/03/2026 01:30:00 PM
- Vivos Inc. Strengthens Patent Protection with New U.S. Patent Issuance and PRECISIONGEL™ Trademark Approvals • GlobeNewswire Inc. • 01/28/2026 01:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2026 04:06:21 PM
- Vivos Inc Summarizes Progress in its Animal Therapy Division • GlobeNewswire Inc. • 12/22/2025 05:56:08 PM
- Vivos Inc Summarzes Preogress in its Animal Therapy Division • GlobeNewswire Inc. • 12/22/2025 01:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/09/2025 09:00:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/21/2025 12:34:42 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/12/2025 11:08:03 AM
- Vivos Inc. Issues Shareholder Update Letter • GlobeNewswire Inc. • 11/06/2025 01:30:00 PM
- Vivos Inc. Strengthens Strategic Collaboration with Exubrion Therapeutics • GlobeNewswire Inc. • 10/29/2025 12:30:00 PM
- Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D., J.D., to Support IDE Submission for RadioGel® • GlobeNewswire Inc. • 10/27/2025 12:30:00 PM
- Vivos Inc Board Authorizes Vivos Inc to Establish a Corporate Entity in India • GlobeNewswire Inc. • 09/29/2025 05:46:00 PM
- Vivos Inc Board Authorizes Vivios Inc to Establish a Corporate Entity in India • GlobeNewswire Inc. • 09/29/2025 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2025 08:01:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2025 07:32:46 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2025 09:14:29 PM
