I suggest that you look at the company's presentation from the World Conference on Interventional Oncology. There's a link to it on the Company's investor relations site. The data is not statistically significant - p-values for the "markedly better" subgroups were only 0.22 and 0.12. To be significant a p-value must be less than 0.05. This drug will never get approved.
Those P values will drop dramaticaly if the trial is slightly altered. They are taking a sub group of the 700 hundred patients, that is why there is a high p value. The trial's STRUCTURE was flawed, not the drug. If they are allowed to submit to FDA based on the 300 patients ALONE then the p value drops below 0.05. If not thwey redo a trial QUICKLY, this time knowing that 45 minutes or more of RFA is needed in combo with Thermodox and they will also get the P value below 0.05. THEN the results WILL be statistically significant.
Hisun Pharmaceuticals of China already knows this, and is talking to their SFDA to allow the drug to approved RIGHT NOW in China based on this knowledge. More will become apparent at the WCIO on Jun 19-22 as Celsion makes their 2 presentations there. They are attending to EXPLAIN what I just told you.
China is not beholden to our FDA, which errs on the side of great caution.
I believe China will allow appeoval NOW. Hisun is partly government owned, and they are into Celsion for 5 million dollars already and have an exclusive manufacturing and distribution agreement which is still in force. THEY want to get their money back and start the profits rolling in. With 50% of HCC in the world occurring in China, and NO standard of care in China, they don't have time to wait. We already know that Thermodox has NO SIDE EFFECTS and is 100% SAFE from the phase 3 trials.
Therefore, CHINA will APPROVE NOW, in my humble opinion, followed by FDA later after new trial is done. Thermodox in China alone is already a billion dollar market. The FDA later is just icing on the cake.