The So-Called Double "Blind" Phase III Trial

Management has been extremely optimistic and voicing it, using such phrases in their recent conference call as:

"(A) dru g that will extend life and perhaps provide a cure"
"No reason to believe that the HEAT study won't be successful"
"The evidence is clearly on our side"
"It's clear that the clinical evidence for a successful HEAT trial is on our side"
"We continue to work diligently to avoid any missteps and to ensure no surprises with the clinical data set"
"(T)he goal here, as I said over and over again, is no surprises."

So that's simply just "blind" optimism, right? Not so fast. While keeping in mind CLSN's goal of "no surprises" with a "blind" data set, think about what they're trying to tell you. CLSN is analyzing everything they can outside of the blinded part of the trial. Well, what could that be?

Easy. ThermoDox contains Doxorubicin. Most people lose their hair within two weeks of getting a dose of Doxorubicin. One would have to be literally blind not to notice who is getting Thermodox and who is getting a placebo in the trials. The CC stated, "Through our clinical quality dashboard we have tracked and evaluated timelessness...and certain trends in the data set which are routinely scoured by our data management team."

Over time during the trial if ThermoDox works, it would become blatantly obvious as the overall surviving patient population would have a continually growing larger percentage of patients without hair. If it didn't work, the ratio would stay roughly the same. For management to be so optimistic, I speculate they have seen or have reports of how many of the survivors have lost their hair and are still around and those numbers blow away the statistics for patients without ThermoDox. "No surprises" indeed. And management already knows the basic number one relevant conclusion: ThermoDox works miracles.