Friday, March 24, 2017 11:33:15 PM
Manufacturing
"We do not have the facilities or expertise to manufacture any of the clinical or commercial supplies of any of our products. To be successful, our products must be manufactured in commercial quantities in compliance with regulatory requirements and at an acceptable cost. To date, we have not commercialized any products, nor have we demonstrated that we can manufacture commercial quantities of our product candidates in accordance with regulatory requirements. If we cannot manufacture products in suitable quantities and in accordance with regulatory standards, either on our own or through contracts with third parties, it may delay clinical trials, regulatory approvals and marketing efforts for such products. Such delays could adversely affect our competitive position and our chances of achieving profitability. We cannot be sure that we can manufacture, either on our own or through contracts with third parties, such products at a cost or in quantities that are commercially viable".
"We currently rely and intend to continue to rely on third-party contract manufacturers to produce vaccines needed for research and clinical trials. We have arrangements with third party manufacturers for the supply of our DNA and MVA vaccines for use in our planned clinical trials. These suppliers operate under the FDA’s Good Manufacturing Practices and (in the case of European manufacturers) similar regulations of the European Medicines Agency. We anticipate that these suppliers will be able to provide sufficient vaccine supplies to complete our currently planned clinical trials. Various contractors are generally available in the United States and Europe for manufacture of vaccines for clinical trial evaluation, however, it may be difficult to replace existing contractors for certain manufacturing and testing activities and costs for contracted services may increase substantially if we switch to other contractors".
Recent GOVX News
- GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine • GlobeNewswire Inc. • 04/04/2024 04:30:00 PM
- GeoVax to Present Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine, at the World Vaccine Congress • GlobeNewswire Inc. • 03/28/2024 01:00:00 PM
- GeoVax to Present at the 36th Annual Roth Conference • GlobeNewswire Inc. • 03/12/2024 01:00:00 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 03/11/2024 08:13:14 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 03/11/2024 04:15:24 AM
- GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System • GlobeNewswire Inc. • 03/06/2024 02:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 03/01/2024 09:08:47 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 09:05:14 PM
- GeoVax Reports 2023 Year-End Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 09:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/22/2024 09:41:26 PM
- GeoVax to Report 2023 Financial Results and Provide Corporate Update on February 29, 2024 • GlobeNewswire Inc. • 02/22/2024 02:00:00 PM
- GeoVax to Present at the 2024 BIO CEO & Investor Conference • GlobeNewswire Inc. • 02/19/2024 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 09:01:35 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:25 PM
- GeoVax Announces Multiple Patent Issuances and Allowances • GlobeNewswire Inc. • 02/13/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:43:48 PM
- GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster • GlobeNewswire Inc. • 02/06/2024 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/31/2024 06:13:27 PM
- GeoVax Announces 1-for-15 Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Requirement • GlobeNewswire Inc. • 01/29/2024 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/16/2024 09:03:40 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/12/2024 09:00:38 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM