Specificity in the 2011 and 2012 validation studies were 91% and 90%, respectively.
I don't necessarily expect sensitivity rates in Deep-C -- which is a more stringent "real world" study -- to be as high as those seen in the validation studies but they should be close. Without a crystal-clear handle on investor expectations for Deep-C results, my best guess is that Wall Street will be happy with sensitivity rates of 90%-plus for cancer and mid-50% for pre-cancerous lesions. Specificity needs to be close to 90%.
Exact Sciences shares, which have advanced just 1.2% this year, have under-performed in 2013 relative to the rest of the healthcare sector. If Cologuard can meet the efficacy hurdles described above, the stock should rally.
I received two emails this week from Dietrich F., both within 24 hours of each other:Email No. 1: "Hey Adam, looks as though you were wrong about Galena Biopharma (GALE - Get Report). The stock has been trading strong and over $2 per share even through a financing round, looks as though the facts that NeuVax has behind it are stronger than your debunked conspiracy theories. When are you going to admit you were wrong?" Email No. 2: "Adam, Galena is about to break through some technical markers and moving in the right direction. How about a follow-up article admitting fault and that your analysis was incorrect on Neuvax's chances." Sorry Dieter, I'm not aware of any conspiracy theories surrounding Galena's breast cancer vaccine NeuVax. In phase II studies, treatment with NeuVax failed to demonstrate a benefit over control in breast cancer patients. Galena mined the negative phase II data to find subgroups of patients where the vaccine appears to work better but these signals are a mirage that will disappear when the ongoing phase III study is completed. Galena shares are up 30% since I wrote about the Galena bear thesis about one year ago. In that same time period, the biotech sector overall is also up 30%, so the appreciation in Galena's stock price is in line and unsurprising. High risk, small-cap biopharma stocks often run up on speculation and momentum. If the NeuVax bear thesis was truly debunked, you'd expect to see institutional investor ownership in Galena increase. That hasn't happened. Only 8% of Galena shares are owned by institutions -- a sign that Wall Street has little interest and no confidence in NeuVax. It's a bit early to invoke the Feuerstein-Ratain Rule on Galena but I expect the stock to fall victim eventually.
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