Replies to post #131890 on Biotech Values

[acgood]

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.

[DewDiligence]

Re: Addressable market for substitutable FoB’s

I do not agree with your implicit assumption in #msg-69361018 that the addressable market for substitutable FoB’s is merely what is left over after non-substitutable FoB’s are deducted from the total market for off-patent biologics. Rather, substitutable FoB’s also have an opportunity to claim a portion of the addressable market for non-substitutable FoB’s (which I estimated at 35-40% of the pie in #msg-69358423).

Proviso: To take advantage of the above, development programs for substitutable FoB have to be started early—i.e. they have to be well into the research phase even now.