Followers | 55 |
Posts | 2608 |
Boards Moderated | 0 |
Alias Born | 02/04/2014 |
Wednesday, July 29, 2015 7:09:02 PM
We applied circa September 2014. The December 2014 meeting notes showed they had questions for some companies and then the January 2015 notes showed that 14 companies withdrew their application. There were no notes as to denials for pancreatic cancer so I did not see that as a real possibility. I would have liked a PR regarding the EMA ODD application status but once we received FDA ODD, it was not necessary and I saw it was possible that we just withdrew.
I personally think that once we got ODD from the FDA, we decided to focus on our studies with TD2. After all, those trials will be coming up first. Also, we were granted FDA ODD in December 2014.
Each link I provided below supports everything I mentioned above. It may look like I over did it on the links but I was just trying to show "good faith", mixer.
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2015/01/WC500180405.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/12/WC500179564.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2014/12/WC500179288.pdf
http://www.dddmag.com/news/2014/10/nuvilex-applies-orphan-drug-designation-pancreatic-cancer-treatment
http://www.marketwatch.com/story/nuvilex-submits-application-for-orphan-drug-designation-to-the-european-medicines-agency-for-its-cell-in-a-boxr-treatment-for-pancreatic-cancer-2014-09-02
http://globenewswire.com/news-release/2014/12/22/693421/10113176/en/FDA-Grants-Orphan-Drug-Designation-to-Nuvilex-for-Pancreatic-Cancer-Treatment.html
Recent PMCB News
- 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
- PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology • Business Wire • 10/31/2023 01:15:00 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/21/2023 09:04:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 09/18/2023 10:04:06 AM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 09/15/2023 09:00:03 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/12/2023 01:56:25 AM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM