Monday, March 06, 2017 9:38:09 AM
OTCQB membership provides enhanced investor benefits including higher reporting standards, increased analyst coverage and access to news services, and more comprehensive compliance requirements. "We anticipate that trading on the OTCQB will raise BioVie visibility in the investment community and broaden our shareholder base," commented CEO Jonathan Adams. "It's an important step towards building BioVie into a larger company."
BioVie recently submitted a complete response to the U.S. Food and Drug Administration (FDA), addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by the Company in January. If notified by the FDA that clinical development of BIV201 may proceed, BioVie expects to commence a mid-stage (Phase 1b) clinical trial in US ascites patients in the next few months.
About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In late 2016, BioVie submitted an investigational new drug (IND) application to the FDA for BIV201 and is awaiting clearance to begin a clinical trial program. This new drug candidate could potentially enter a mid-stage (Phase 1b) US clinical trial in early 2017. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
DISCLAIMER: All I say is just IMHO and does not construe investment advice. My wife informs me frequently that I know nothing and I say you should trust no one on the internet.
Recent BIVI News
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 09/23/2024 08:13:11 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 09/17/2024 08:57:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/21/2024 01:31:07 AM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 08/06/2024 10:00:32 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 08:41:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:15:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 10:02:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 10:01:48 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/17/2024 09:05:11 PM
- Join BioVie’s Exclusive Live Investor Webinar and Q&A Session on June 26 • GlobeNewswire Inc. • 06/12/2024 12:24:05 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 06/07/2024 09:05:11 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 09:06:16 PM
- 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
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