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Biotech / Medical : Zonagen (zona) - good buy?
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To: Dauntless who wrote (1494)1/5/1998 10:00:00 PM
From: Dauntless  Read Replies (2) of 7041
 
What's a "P VALUE"

P value is a statistical term that is almost always seen in a company's description of the results of their clinical trials. Here is a simple, yet perfectly clear definition of the term:

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The probability of obtaining a given outcome due to chance alone. For example, a study result with a significance level of p<0.05 implies that 5 times out of 100 the result could have occurred by chance.

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From the Zonagen web site (& various press releases) -

Zonagen recently completed two U.S. Phase III clinical trials with Vasomax. The first of these was a double-blinded placebo-controlled study involving 435 men at 20 centers. Vasomax yielded a statistically significant (p<0.001) improvement over placebo, with 40% of the men responding to the 40 mg dose as compared to 17% responding to placebo. The second trial involved 293 men at 14 centers and also resulted in a statistically significant improvement over placebo. As in all previous studies, there were no significant adverse events at the 40 mg dose.

I believe this implies that this result could have happened by chance in less than 1 out of 1,000 studies. And this in trials that were designed with guidance from the FDA regarding endpoints, etc. These are excellent p-values and clearly indicate that the drug was effective.

No ranting or raving here - just FDA approved scientific studies that yielded statistically significant results.
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