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GNTA.OB > SEC Filings for GNTA.OB > Form 8-K on 19-May-2009All Recent SEC Filings

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Form 8-K for GENTA INC DE/

19-May-2009

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

On May 19, 2009, Genta Incorporated, (the Company), announced that the independent Data Monitoring Board (DMB) for AGENDA, a randomized Phase 3 trial of Genasense® in patients with advanced melanoma, has informed the Company that the study has passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion.

Coincident with this recommendation, Genta has submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), along with a request for assignment of rapporteurs. Such notice is required prior to submission of a Marketing Authorization Application (MAA).



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits. 

Exhibit
Number    Description
 99.1     Press Release of the Company dated May 19, 2009

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