Monday, April 05, 2021 11:46:51 AM
The FDA doesn't judge business models.
Outside of eye-of-newt to cure Covid, the FDA will review anything "reasonable" submitted to them.
The FDA also can not predict the plans of a biotech/Pharma. PMCB is not going to get a Phase 2b CT approved. However, maybe some year Kenny will start at Phase 1. And when that fails using PFS as an endpt, then Kenny might be able to switch to a trial for palliative treatment. Which is difficult to get marketing approval for in this instance. In any case the pre-clinical tests required for a Phase 1, or palliative treatment CT, would be the same as they are today. Or Kenny may have already decided he'll just PR pump for another 2 yrs, and then walk away. In all scenarios the FDA isn't in the business of predicting what future direction a company might take with its proposed treatment. Instead the FDA tells the company of any pre-clinical and/or protocol deficiencies in a submitted IND. There's nothing to "entertain".
The Jewel of the Mind is Colored with the Hue of what it Imagines
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
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