Monday, August 1, 2011

Awaiting HEAT enrollment and 190 PFS Events

I expect very shortly (this week at latest)Celsion will issue a press release reporting completion of enrollment in their Phase 3 HEAT study. Investors should carefully read the PR for clues or direct guidance as to whether or not 190 PFS events, half of the total 380 necessary for topline readout, has occurred yet. To reiterate, BOTH enrollment completion AND realization of 190 events are required for the upcoming interim analysis, with results due by end of September. There has been a lot of discussion amongst shareholders regarding the timing of the 190 events and the median expected PFS of the control arm. Assuming 12 months for the control arm, one could argue that the fact that 190 has not been achieved yet (assuming that is indeed true), bodes very well for the Thermodox arm in the HEAT study. We will just have to wait and see. I personally think 190 has not happened yet, but I also think the control arm might be doing better than than the 12 months management is forecasting.

We will just have to wait and see, but keep your eyes peeled for that PR regarding enrollment.


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