Monday, January 08, 2018 8:57:55 PM
Additional Clinical Efficacy Analysis:
• Assessment of clinical meaningfulness (MCID) demonstrated clinically
important differences across all dosing cohorts
• Anchor based analysis results indicated that each of the 5 potential
anchors met the meaningful change threshold
Updated Safety:
• We believe safety deficiencies from CRL have been fully addressed
• Clinical safety profile from phase 3 studies has not changed with
greater than 1 million uses around the world
• The majority of AEs have been mild to moderate, local to the site of
administration, transient in nature with event durations of less than
two hours
Updated CMC/Module 3:
• All the CMC deficiencies from the CRL have been addressed
• Results from successful Human Factors Test were included in
resubmission
• Manufacturing process and manufacturing sites were updated in the
resubmission
Recent SEEL News
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 03/06/2024 10:32:04 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 09:50:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/01/2024 10:39:18 PM
- Form D - Notice of Exempt Offering of Securities • Edgar (US Regulatory) • 02/14/2024 09:50:49 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/06/2024 10:26:45 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 02/02/2024 11:04:12 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 09:01:23 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 01/30/2024 11:05:53 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 01:05:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 02:47:31 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 02:47:06 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/10/2024 09:16:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2024 02:46:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2024 02:45:51 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2024 02:45:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2024 02:45:13 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 01/02/2024 01:10:24 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/22/2023 09:01:19 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/22/2023 01:10:14 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/20/2023 09:59:16 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/20/2023 09:54:15 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 12/18/2023 09:54:05 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 12/15/2023 09:06:26 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 12/04/2023 09:05:27 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