Thursday, May 28, 2015 10:47:39 AM
FDA Advanced Approval in 6 weeks, After 24 Week Global Tests Start (30 sites, Imetelstat)
"Patient benefits are typically apparent by the third dosage (six weeks after first treatment). Patients showing complete remission have shown reversal of fibrosis and even complete molecular response an astounding feat for a drug with patients who had been faced with near term death after other treatment failures."
JNJ/Janssen will be transparent about the progress of the new global, international trials. The FDA, while still one of the most important approval agencies, there are similar agencies in most countries. The FDA may not be the first to grant advanced IMET approval for the treatment of a basket of blood cancers (MF, MDS, AML).
"evil flourishes when good people fail to act"
Recent GERN News
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 06/20/2024 08:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/12/2024 08:05:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/12/2024 08:05:04 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/10/2024 09:53:19 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/10/2024 04:30:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:03:44 PM
- Geron Announces FDA Approval of RYTELO™ (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia • Business Wire • 06/07/2024 01:58:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/05/2024 08:05:20 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/04/2024 09:02:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 08:05:30 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 05/16/2024 08:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/15/2024 08:07:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:05:15 PM
- Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights • Business Wire • 05/02/2024 11:00:00 AM
- Geron to Announce First Quarter 2024 Financial Results on May 2, 2024 • Business Wire • 04/25/2024 08:30:00 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 04/18/2024 08:30:00 PM
- Geron to Participate at Upcoming Investor Conferences in April • Business Wire • 04/03/2024 08:30:00 PM
- Geron Corporation Announces Pricing of $150 Million Underwritten Offering of Common Stock and Pre-Funded Warrants • Business Wire • 03/19/2024 01:07:00 PM
- Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS • Business Wire • 03/14/2024 07:54:00 PM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM
North Bay Resources Announces Successful Flotation Cell Test at Bishop Gold Mill, Inyo County, California • NBRI • Jun 27, 2024 9:00 AM
Branded Legacy, Inc. and Hemp Emu Announce Strategic Partnership to Enhance CBD Product Manufacturing • BLEG • Jun 27, 2024 8:30 AM
POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • POET • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM