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Post# of 252302
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Alias Born 10/18/2003

Re: nicksdad post# 46

Sunday, 10/19/2003 11:05:19 AM

Sunday, October 19, 2003 11:05:19 AM

Post# of 252302
nicksdad,

As I stated previously, and the p/r from ppl showed, the genaera results weren't powered to show a statistically significant" result, with only 55 patients enrolled and a 4 week dosing regimen.

The proof of concept trial showed that the people on the drug seemed to improve a tiny bit while the placebo group kept deteriorating. In CF that is a homerun.

Unfortunately for genr it was a single or double because it didn't knock anyone's socks off, and the stupid Dow Jones article said it failed to meet statistical significance even though it wasn't powered to. Day traders and morons that shouldn't be in the market saw the term and sold.

As I previously mentioned Genr and CF foundation will be going through the data looking for data on subsets. It could be that the drug worked better on milder cases for example. If that is the case the next trial may be in milder cases.

The one thing I am surprised about is that they should have kept people on the drug for at least 3 months in an open label setting to see if they kept making improvements the longer the drug was used. This could have helped when structuring the new trial.


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