Feels like a pivotal quarter. Best scenario, Celsion wants a solid financial position to allow them to wait for data to mature and get better terms in a partnership.
Looking at the bar for approval based on Nexavar SHARP results.
The approval of sorafenib in 2007 for the treatment of HCC patients in both the United States and the European Union represents a true paradigm shift in the treatment of advanced HCC and is a clinically meaningful therapeutic advancement in this challenging malignancy. Interestingly, a subsequent prospective controlled trial of sorafenib in Asian patients with the same design and eligibility criteria as the SHARP trial showed an improvement in OS with a hazard ratio similar to that of the SHARP trial. However, the Asian study showed significantly lower absolute benefit (6.2 months median survival in the study arm v 10.7 months in SHARP) and possibly overall lower toler- ance of sorafenib.105 Understanding the reasons for such differential effects is essential to inform the design of future trials in HCC and underscores the importance of identifying stratification factors in future clinical trials, such as hepatic function, ethnicity, disease etiol- ogy, and tumor molecular profile.
http://files.shareholder.com/downloads/CLN/0x0x393141/dba27485-464e-4cec-a208-ca3f5d2f85de/JCO_2010_-_08-03-2010_ThermoDox_Chart_3.pdf
The second trial
226 Asian patients
median overall survival of 6.2 months for sorafenib and 4.1 months for placebo. There was also a significant 74% improvement in time to progression, with a median time to progression of 2.8 months for sorafenib and 1.4 months for placebo
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM