Phase 2 Testing Was Skipped Over - Phase 1 Only 24 Patients Sampled
Now that we are reaching the end, lets have an open discussion about where we are:
Phase 1 Testing Only Had A Total Of 24 Patients. It was skipped to phase 3 because the antibiotic that thermodox administrates, Doxorubicin, was already well known by FDA, and of course the importance of the results from the study (billion dollar market that can make a huge impact on humanity
You can read the Phase 1 study at the official company website in .pdf form.
With only one small trial to give credit, we are looking at either huge gains or a catasrophic loss.
I am also interested in this stock and why people are so bullish. I see insider buying at market prices and this is very bullish(their own money) - and probably last chance for them to buy before the 30 day moratorium kicks in. I have seen the animal studies also and that is encouraging. What else makes people think this is a slam dunk or a hit and miss?
1) the only variable that mattered in the Phase I was dose.2) Dox is used for many cancers WW .3) Celsion and Duke have shown that TDOX gets 7-10 times the Dox in the tumor and 20-25 times in the RNA/DNA of tumors. 4) Most think that the control arm should have an average PFS of 12-16 months but the Heat trial has an average overall PFS of 20-22 months. 5) The Heat trial has some of the worlds leaders in liver cancer as PI's and they have been very vocal about the value of TDOX. 6) The DMC has reviewed safety about every 100 patients and every time they have said continue the trial. 7) the insiders have not sold one share since 2005 and have been buying in the open market and on offerings.8)The management has basically put their jobs at risk by saying they will not raise capital until after data. 9)The FDA and EMA and China and Japan have all been very very helpful....SPA....Fast track....Orphan drug status. 10) with only 36 million outstanding and 50 million fully diluted the risk reward looks very very good. 11) The only part of the globe that has been sold is Japan so given strong data CLSN will be in the catbird seat as far as lic deals. I am getting tired of typing but you get the idea.
Well we know the already approved drug being used works on it's own as an historical fact. We also know the drugs presence is amplified in the tumors due to the new nano + heat delivery system. The belief is that a much higher concentration of medicine in the tumors will diametrically improve the drugs results creating a new paradigm of treatment for many types of cancer. This will create a few new millionaires if all goes as planned as we expect it to.