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Wednesday, October 16, 2019 3:34:42 PM
1) Completion of the second run
2)Release testing
A few other key events will play themselves out in the weeks to come—all leading to the submission of the IND. The first of which has already begun. PharmaCyte stated this week that the second of two staggered and back-to-back manufacturing runs is already underway, and that the cells from the company’s Master Cell Bank (MCB) are growing well in this second run and will be encapsulated within the next week or two.
The most important event left to complete outside of the final manufacturing run is “release testing” of the clinical trial product. PharmaCyte said that a representative sample of frozen syringes from the first successful manufacturing run, which are filled with 300 Cell-in-a-Box® capsules each, are in the process of being shipped to external testing labs for the release testing that is required by the FDA
The data that those tests will produce are all that remains for the company to complete the IND and then submit it to the FDA.
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
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- 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
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:45 PM
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- 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
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- 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
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