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Biotech / Medical : Biotech Valuation

CRSP 56.87

-2.3%

Dec 5 9:30 AM EST

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To: Ian@SI who wrote (9123)	9/15/2003 12:09:38 AM
From: BulbaMan	Read Replies (2) of 52153

>>>If the FDA entertains Genta's subgroup argument -- and the agency has rejected such special pleading with other firms' cancer studies -- Genta's post-study evidence would only impact the study's statistical significance. The one month difference wouldn't change.<<< The above claim in the Barron's piece makes no sense. If one assumes (as Genta/Aventis do) that the data for the 291 patients in the Genasense trial yet to reach the 12 month cut-off will be equivalent to the data for the 480 patients that have already reached the cut-off, then Genasense's median survival advantage for the 291 patients would be the same two months as for the 480 patients. So, the median survival advantage for all 771 patients would also be two months, not one month.

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