Columbia Laboratories, Inc. (CBRX)

[keekee]

Just reread the text of the AD-OP on FDA website and you will be grabbing this with three hands. The issue being addressed by WPI is not whether "Progestrone Gel" is statistically signifant versus placebo. No, the beef was only in the method used by CBRX in analyzing the results. WHile CBRX "pooled" the results, FDA analyst reviewed the results by region. In non US regions - Prochieve was statistically significant. In fact, In South Africa and Belarus, not s single preterm was recorded in women using progestrone gel while preterm birth levels on subjects on placebo was disturbing. Here's an exerpt "South Africa (with 11 placebo subjects and 10 progesterone gel subjects) and Belarus (with six placebo subjects and five progesterone gel subjects) had very high rates of preterm birth in the placebo subjects, and no preterm births at = 32 6/7 weeks among progesterone gel-treated subjects. This resulted in a large treatment effect favoring progesterone gel in these countries."

Even results from India and Ukraine supports statistical significance "In contrast, preterm delivery rates among placebo subjects in India and Ukraine are very low, but still 4-8% higher than those among progesterone gel-treated subjects."

Also, by race, Prochieve was statistically significant "Overall, there was minimal efficacy in Asian subjects, possibly because the background rate of prematurity was quite low.
Efficacy in Caucasians and Blacks favored progesterone gel. In Caucasians, the treatment benefit was greatest in the earlier gestational ages, while in Blacks, efficacy increased as gestational age advanced."

The US result is not reliable because there was heavy non-compliance. Of course, US preterm background was also a noted variable. And when you consider that incidences of preterm would be diminished in the US because of superior medical systems vs the five other countries in the trial, you'd be loading up as I have on the stock. The FDA reviewer needed additional data since, according to him, the USresult of the "single" study did not make the overal result to be of "highly persuasive significance." Hence additional data is needed.

And, as I have always stated, the stock is already dirty cheap on its own. When you add the Perceived Future Value of Prochieve being approved, you see a multi-badger! Don't forget the short numbers. I am sure most of you are in already. Goodluck and Happy President's Day!