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Titan Pharmaceuticals: How Did It Get Here and Where Is It Going?
This morning, Titan Pharmaceuticals (Symbol:
) announced the receipt of a letter from the U.S. Food and Drug Administration (
), which provided comments on a revised Statistical Analysis Plan (
) for the confirmatory Phase III study of Probuphine for patients with opiod dependence. The release of this letter from the FDA sent the stock price plummeting to a low of $1.30 in the first ten minutes of trading on Friday before settling into a range of $1.50 to $1.60 as of 12:00 eastern time. Per the press release, Titan notes that all 20 locations have completed a data review, with the blinded double set ready to be analyzed.
With the release, speculation is a bound regarding what the plausible causes are for the revised SAP, which potentially can range amongst: missing data, fraud, control group and biomarker issues, statistical Type I and/or Type II errors, lapses within the double blind process.
At this point, it is too early to divulge into this speculation until Titan provides its shareholders with the characteristics of the revised SAP.
Jun 17, 2011. 11:53 AM
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