Biotech Values

[DewDiligence]

FDA says Genta's “…study results may be falsely positive”

[Could this be another biotech scam in which the company tells investors a story that’s the polar opposite of reality? The last paragraph of this newswire, which quotes the company itself, is not exactly reassuring.]

http://biz.yahoo.com/rc/040430/health_genta_2.html

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FDA staff questions Aventis, Genta cancer drug data

Friday April 30, 10:15 am ET

WASHINGTON, April 30 (Reuters) - Effectiveness claims for a Genta Inc. (NasdaqNM:GNTA - News) and Aventis SA (Paris:AVEP.PA - News) cancer drug are "questionable" because study results may be "falsely positive," U.S. Food and Drug Administration (News - Websites) staff said in a initial analysis released on Friday.

The companies are seeking approval for the drug, called Genasense, for treating advanced melanoma, a deadly type of skin cancer.

Shares of Genta, a small biotech company, plummeted as much as 30 percent on Nasdaq before recovering somewhat. The shares were down $3.63, or 25 percent, to $10.80 with 4.2 million shares exchanged in morning trading.
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The FDA analysis, which will be presented to an advisory panel on Monday, was posted on the agency's Web site at http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037B1_02_FDA-Genasense.pdf

"It is the company's policy not to comment on the contents of the briefing information prior to the advisory committee meeting," Genta said in a statement.
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