Genta, Inc (fka GNTAQ)

[The Holder]

It is important to realize...

...that the FDA asked for a confirmatory phase III study for the approval of Genasense in CLL. They did not get one.

The FDA and the EMEA asked for an additional clinical study in order to confirm efficacy and safety of a prior phase III study in the treatment of melanoma. The are getting one.

The Agenda Trial is a confirmatory study of a specific subset in a prior phase III study. This confirmatory study looks at individuals in the prior phase III study with low to normal LDH levels, who showed MAXIMUM BENEFIT and supported the approval of Genasense + chemotherapy in the treatment of melanoma, world-wide. They are confirming using this subset ONLY. They only need to reproduce the results of the prior phase III study in this group. That's what they're trying to accomplish. They're nearly fully enrolled (if not completely enrolled already).