Celsion Corporation (CLSN)

[sdtrond]

There are only two looks - the interim and the final.
Keep in mind the DMB can stop the trial at any time for futility (but with all the safety reviews-to-date, this should NOT be an issue in HEAT).

The interim occurs after enrollment of 600 and 190 PFS events. Couple minor point to keep in mind - they can continue to enroll past 600 to make up registrational trials in Japan (currently at 18, need 60). I believe but do not know that other Asian countries could continue to enroll in like fashion.
Those two events should occur, per the company, within 2-3 weeks. The interim calculation includes collecting all data from all trial sites, verifying that data, and then unblinding the data so they can get statistical info across the arms. This whole process takes from 6-8 weeks. They have already guided for (and reiterated) results by the end of September, so about 9 weeks to go in total.

The DMC can either recommend stopping for futility, for filing for early approval, or a continue to the final look.
Futility should be an extraordinarilly low probability.
Early approval filing is also low. May be as high as 25% or so, but it's still a lottery ticket for now.
Rec to continue is the most likely prospect.

In that case, company guidance for the 380 (in the 12/1/10) CEO letter on the website) is "At the current enrollment, we are likely to see enough events (380) for study read out in the next 14-16 months." KEEP IN MIND that enrollment has lagged severely, so that 14-16 months will probably be extended. If it was 2/12 - 4/12 before, I'd not be surprised to see it be 7/12 to 11/12 before we get the 380.

We will get much greater clarity after the interim calc.