Summary of the THLD presentation from June 7 (Jefferies Conference) - pretty interesting. The CEO seems extremely sharp and he reviewed the results from their full statistical analysis of the failed Phase 3 study. It turns out they would have met statistical significance in the trial if 2 of the 600+ patients that had originally been randomized into the drug group hadn't dropped out prior to treatment and then returned to the trial but then randomized into the placebo group instead. The trial was designed as 'intent to treat' so these 2 patients had to be considered dropouts, and this skewed the data just enough to barely miss statistical significance.
Several other oddities in the trial were 1) the unexpectedly long survival of patients in the control arm, and 2) the very high efficacy seen in the patients treated in Japan. It turns out that Orientals metabolize certain drugs differently than do Caucasians, and the Japanese patients showed very high levels of efficacy. He said that THLD is actively pursuing a partnership in Japan for the drug.
So that's one possibility that could explain the recent move in the stock, ie some progress on the Japanese partnership front.
With that type of info it would be difficult to prevent a fair number of people from realizing that something is up, and then the word leaks out to hedge funds and others, and the stock starts really moving. Just a guess though.
I was impressed with the CEO. I remember listening to their December conference call when the Phase 3 failed, but otherwise haven't followed the company. Their drug is a prodrug that is activated in the hypoxic conditions (low oxygen level) found in some type of tumors. Pretty interesting, and its clear the drug does have activity, and could potentially get approved in Asia.
