Changing gears: Do geographical differences matter when it comes to the validity of clinical trial data? For Medivation (MDVN) and its Alzheimer's drug Dimebon, a positive phase II study from Russia looks foolishly deceptive in the face of negative Dimebon results from a phase III study done in Europe and the U.S.
Eric B. writes, "I know that Targacept (TRGT) had a small number of U.S. patients for their Phase II depression study (single digit percentage). The vast majority were in India. Is India more reliable than Russia? Yes, but it sure would have been nice if Targacept had disclosed the results by geography. Targacept says that any such comparison wouldn't be statistically significant because of the small number of U.S. patients. Huh? It's not about statistical significance. It's about seeing if the U.S. results raise questions... Bottom line, Targacept's Phase II results are worth less than they would be if they were 100% from the U.S."
I'm a fan of Targacept and its depression drug TC-5214, but I'll concede Eric's point. The fact that the phase II study was conducted primarily in India probably is an overhang and may be one reason why the Targacept's stock price isn't higher. (The lack of near-term Targacept catalysts, including a long weight for phase III data, weighs on the stock, too.)
I ran Eric's comment by a hedge fund analyst source who focuses on neuro-psych drugs. He can't be quoted by name, but he's also a Targacept bull.
"I think India has more experience conducting clinical trials and is better equipped to handle the issues that eventually turned Dimebon into a false hope, but until we see corroboration of the data elsewhere (or a publication/presentation splitting geography), the question will be outstanding," he says.
Kevin C. emails, "Adam, I would like to get your opinion on Somaxon Pharmaceuticals (SOMX). They will receive an FDA decision by March 20th and the stock has been running the past month. What do you believe are the odds of approval this time, and what do you believe is the market potential of Silenor if approved?" Oops. I'm a tad late since the FDA approved Silenor as a new treatment for insomnia on Thursday. The positive news, helped along by a small float and few shares to short, sent Somaxon's stock price into orbit. At Thursday's close, Somaxon was up 133% to $9.21 a share on colossal volume of 47 million shares.
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