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« Biotech/Pharma Docket | Main | Conference & CLE Calendar »

March 24, 2011

Comments

All this discussion on statistical significance and scientific evidence rather misses the point, which is whether the information would be material to an INVESTOR.

As a scientist, I might conclude that the evidence is statistically insignificant, but on that same evidence I'd still sell my shares, because the information is highly relevant to their market value.

Dear James:

Which is what the court held. And I don't disagree with the outcome here, just the dismissal of statistical significance as being a reasonable basis for Matrixx to think they didn't need to make the disclosure.

For example, what it the initial 10 people were the only 10 people in the world who had this side effect? Horrible for them (if it was permanent; the case doesn't say it was), but sufficient for the drug to be pulled from the market? After all, even with the "warning" the FDA required in 2009, what does the consumer do? Use the drug until he loses the sense of smell a little?

I don't think the court was wrong in this case. But if you read some of the other commentary out there, the take-home for many is that statistical significance is irrelevant. Which goes to far in the other direction.

Thanks for the comment.

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