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Replies to #46 on Biotech Values
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DewDiligence

10/19/03 3:32 AM

#47 RE: nicksdad #46

Frank: the Lomucin results were not bad. But there was insufficient evidence to say that they were good.

To use a courtroom analogy: if you were on the jury you would certainly not vote to convict. However, you were not fully convinced that the defendant was innocent. What you really wanted to do was vote “not proven” (which I have heard is a juror’s prerogative at criminal trials in Scotland).

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I think Lomucin is on temporary hold until GENR’s money situation becomes clarified. When we get a partnership for Squalamine, the up-front cash may be sufficient to restart the Lomucin program, with or without continued funding from the CF Foundation. JMHO. Dew

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drbio45

10/19/03 11:05 AM

#50 RE: nicksdad #46

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.