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Re: iwfal post# 131890

Monday, 11/28/2011 8:48:05 AM

Monday, November 28, 2011 8:48:05 AM

Post# of 257295
iwfal or others - can you chime in or parse this statement from the CLSN press release this morning?

Celsion Announces Unanimous Recommendation by Independent Data Monitoring Committee to Continue and Complete Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer as Planned
Company May Conduct Additional Interim Efficacy Analyses Following Agreement With FDA Reconfirms 380 PFS Events Projected to Occur in Late 2012

http://www.marketwatch.com/story/celsion-announces-unanimous-recommendation-by-independent-data-monitoring-committee-to-continue-and-complete-phase-iii-heat-study-of-thermodoxr-in-primary-liver-cancer-as-planned-2011-11-28?reflink=MW_news_stmp

Celsion also announced today that the DMC, in its review, followed a statistical boundary determined by the Company using the Lan DeMets implementation of the O'Brien-Fleming spending function. This approach allows for the Company to conduct additional interim efficacy analyses prior to final data read-out at 380 PFS events with no increased risk of statistical penalty. The additional analyses may allow for earlier stopping of the study. Additionally, based on its internally modeled estimates of PFS events, Celsion reconfirmed that 380 PFS events are projected to occur in late 2012.


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