Monday, January 02, 2017 11:04:45 AM
And the best news of all for investors heading into these exciting times is that PharmaCyte has been awarded the Orphan Drug designation by both the U.S. FDA and the European Medicines Agency (EMA). This designation means that the company's pancreatic cancer therapy will have complete protection and market exclusivity for years to come. After PharmaCyte's therapy is approved for marketing by these two regulatory agencies, they will enjoy 7 years of market exclusivity in the United States and 10 years of protection in the European Union.
PharmaCyte's CEO also recently stated that the company's pancreatic cancer therapy qualifies for 12 years of data exclusivity because it is considered a "biologic" as outlined by the Biologics Price Competition and Innovation Act (BPCIA).
So, as the company marches headlong into a Phase 2b clinical trial in the U.S. and Europe with a built in "hard stop" about half way through the trial to review the data, there is no better time than the present to get excited about this small biotechnology company and what could very well be a significant contribution to the treatment of pancreatic cancer.
Recent PMCB News
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/13/2024 08:37:40 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 07/29/2024 08:05:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:59:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:58:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:58:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:58:35 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/30/2024 08:05:04 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 05/30/2024 08:05:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 08:40:20 PM
- PharmaCyte Biotech Makes $7 Million Strategic Investment in MyMD, A Biopharmaceutical Company Focused on Inflammatory Disease • Business Wire • 05/21/2024 01:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:38 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 02:56:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 12/15/2023 10:25:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/24/2023 09:00:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:02:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:02:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:00:10 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 11/22/2023 09:00:15 PM
- PharmaCyte Biotech Acquires $5 Million Stake in Emerging Women’s Health Innovator Femasys, Inc. • Business Wire • 11/15/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 10:25:09 PM
- PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology • Business Wire • 10/31/2023 01:15:00 PM
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