The bashing continues on the Seeking Alpha comments section from the lastest article. Here's what one basher says:
and here's my response.
Remember Mark Twain's famous line? "There are 3 kinds of lies: lies, damn lies, and statistics." The FDA approval rate for a drug that is safe and effective approaches 100%. You're basing your statistical claims on a false premise. It doesn't matter how many drugs fail when they aren't safe and effective -- what matters is the likelihood that the drug in question will be approved. For example, if less than 1% of college football players end up with a professional football career, does that mean that NO ONE succeeds in becoming a professional player? No, it does not. The statistical incidence of failure does not affect the success of the best players.
All drugs in clinical trials and all clinical trial designs are not equal. By understanding the science and the progress of the clinical trials an astute observer can determine much more logical estimates of the chance of success. So far all of CTIX's clinical trials have been successful. There have been no serious side effects, and there are signs of efficacy. If you investigated the scientific progress so far, the mechanism of action of the drugs, the pre-clinical animal studies, and the clinical trial design for these specific investigational drugs, you might also see why so many astute investors are excited by these drugs.
You also quote a statistic from 2008. Perhaps you are unaware that in the past 8 years, the FDA has made some significant changes in the way they review drugs, and researchers have become more sophisticated in trial design and selection of which drugs to send through the approval process. Your statistic about trial success or failure in 2008 has very little to do with the chance of success for CTIX's pipeline in 2016 -- especially given that several of the drugs CTIX is studying are first-in-class. For instance, currently there is NO FDA-approved drug for oral mucositis. The chance of approval is very, very high for a drug that offers relief for some patients who suffer from this condition. Likewise, the chance of approval for CTIX's one-dose antibiotic from an entirely new class of antibiotics (at a time when there are grave concerns about antibiotic resistance world-wide) is much higher than the chance of approval for, say, a new cholesterol drug or other less urgent need.
If it were possible to separate out the approval rate for drugs that have received QIDP status or orphan drug status from the FDA (as some of CTIX's drugs have), and to see a statistic about approval rates for these sub-categories of drugs from the past couple of years, I'd pay some attention to such a statistic. But in this case, your statistic is definitely in Mark Twain's Category 3.
Astute investors will not be scared by bogus statistics.
Quote:The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.
and here's my response.
Remember Mark Twain's famous line? "There are 3 kinds of lies: lies, damn lies, and statistics." The FDA approval rate for a drug that is safe and effective approaches 100%. You're basing your statistical claims on a false premise. It doesn't matter how many drugs fail when they aren't safe and effective -- what matters is the likelihood that the drug in question will be approved. For example, if less than 1% of college football players end up with a professional football career, does that mean that NO ONE succeeds in becoming a professional player? No, it does not. The statistical incidence of failure does not affect the success of the best players.
All drugs in clinical trials and all clinical trial designs are not equal. By understanding the science and the progress of the clinical trials an astute observer can determine much more logical estimates of the chance of success. So far all of CTIX's clinical trials have been successful. There have been no serious side effects, and there are signs of efficacy. If you investigated the scientific progress so far, the mechanism of action of the drugs, the pre-clinical animal studies, and the clinical trial design for these specific investigational drugs, you might also see why so many astute investors are excited by these drugs.
You also quote a statistic from 2008. Perhaps you are unaware that in the past 8 years, the FDA has made some significant changes in the way they review drugs, and researchers have become more sophisticated in trial design and selection of which drugs to send through the approval process. Your statistic about trial success or failure in 2008 has very little to do with the chance of success for CTIX's pipeline in 2016 -- especially given that several of the drugs CTIX is studying are first-in-class. For instance, currently there is NO FDA-approved drug for oral mucositis. The chance of approval is very, very high for a drug that offers relief for some patients who suffer from this condition. Likewise, the chance of approval for CTIX's one-dose antibiotic from an entirely new class of antibiotics (at a time when there are grave concerns about antibiotic resistance world-wide) is much higher than the chance of approval for, say, a new cholesterol drug or other less urgent need.
If it were possible to separate out the approval rate for drugs that have received QIDP status or orphan drug status from the FDA (as some of CTIX's drugs have), and to see a statistic about approval rates for these sub-categories of drugs from the past couple of years, I'd pay some attention to such a statistic. But in this case, your statistic is definitely in Mark Twain's Category 3.
Astute investors will not be scared by bogus statistics.
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