"On June 18, 2019, we met with representatives of the U.S. Food & Drug Administration ("FDA") for a Type C Guidance Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial. We discussed our clinical development efforts with the FDA and proposed safety and efficacy endpoints for our next clinical trial. In July 2019, the FDA provided its meeting minutes for this meeting that documented general agreement with the Company's proposed randomized clinical study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints and other key aspects of our clinical trial design including appropriate quality of life measures. On October 1, 2019, the Company submitted a Phase 2b/3 randomized, controlled clinical trial protocol to the FDA incorporating these suggestions. If this trial demonstrates significant improvement on various measures of patient health status, we believe it could potentially form the basis to submit a new drug application (NDA) for the eventual marketing of BIV201 in the US. While the FDA has not provided final guidance nor do we have certainty as to what that guidance would entail, our goal remains to commence the planned Phase 2b/3 trial in the next several months in a manner consistent with what was reviewed with the FDA. We may still need to address certain risks associated with yet to be validated quality of life measures."
"In September 2019, the Company manufactured the first batch of a novel patent-pending liquid formulation of terlipressin for use in the Phase 2b/3 trial subject to FDA clearance. This new product format is intended to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the powder version."
Recent BIVI News
- The Gross Law Firm Notifies Shareholders of BioVie Inc. (BIVI) of a Class Action Lawsuit and an Upcoming Deadline • PR Newswire (US) • 03/14/2024 09:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/11/2024 09:00:30 PM
- BioVie Inc. Class Action: The Gross Law Firm Reminds BioVie Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of March 19, 2024 - BIVI • PR Newswire (US) • 03/11/2024 09:45:00 AM
- Contact The Gross Law Firm by March 19, 2024 Deadline to Join Class Action Against BioVie Inc.(BIVI) • PR Newswire (US) • 03/07/2024 10:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 10:10:37 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 03/04/2024 10:28:48 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 03/04/2024 10:28:02 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 12:50:52 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 03/01/2024 10:27:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/01/2024 02:40:39 PM
- The Gross Law Firm Notifies BioVie Inc. Investors of a Class Action Lawsuit and Upcoming Deadline - BIVI • PR Newswire (US) • 02/26/2024 10:45:00 AM
- The Gross Law Firm Reminds BioVie Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of March 19, 2024 - BIVI • PR Newswire (US) • 02/09/2024 10:45:00 AM
- The Gross Law Firm Notifies Shareholders of BioVie Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of March 19, 2024 - (NASDAQ: BIVI) • PR Newswire (US) • 02/02/2024 10:45:00 AM
- The Gross Law Firm Notifies Shareholders of BioVie Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of March 19, 2024 - (NASDAQ: BIVI) • PR Newswire (US) • 01/26/2024 10:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 10:00:41 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/19/2024 10:15:31 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 10:00:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/13/2023 10:15:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/06/2023 09:16:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/06/2023 09:15:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/29/2023 01:20:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 09:30:46 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/08/2023 09:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/25/2023 05:04:10 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/29/2023 09:20:39 PM
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