Genta, Inc (fka GNTAQ)

[The Holder]

Chances looking good...


Genta Incorporated (Nasdaq: GNTA) announced that the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has decided that available data are not adequate to support approval of Genasense® (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In a decision issued in response to an appeal filed by Genta in October 2007, CDER acknowledged that complete response, which was the primary endpoint in the pivotal trial, was an appropriate endpoint for assessing efficacy. FDA also agreed that this endpoint was achieved, and that those results supported the efficacy of the drug. However, CDER concluded that at present there was insufficient "confirmatory evidence" in the New Drug Application (NDA) to approve the drug.

CDER recommended two alternatives for exploring the efficacy of Genasense that could provide such confirmatory evidence. One option is to conduct an additional clinical trial. The other option is to collect additional information regarding the clinical course and progression of disease in patients from the previous pivotal trial in order to ascertain whether those data contain sufficient confirmatory evidence. The Company currently plans to pursue both of these options.
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Alright, didn't we just hear in the investors conference that they obtained new data on the progression of disease in patients from the previous clinical trial? I certainly think we did and it was very eye opening. It was very significant.

So it acheived it's primary endpoint AND has new data on the progression of disease in patients from the previous trial that were undeniable. This is EXACTLY what the FDA asked for, was it not? You can read just as well as I can. Now this from Genta's site:

Phase 3/Chronic Lymphocytic Leukemia (CLL)/NDA Status: Genta has appealed a prior “non-approvable” decision on the Genasense® New Drug Application (NDA) for patients with relapsed/refractory CLL. The appeal is now pending a decision by FDA’s Center for Drug Evaluation and Research (CDER). The pivotal randomized trial achieved its primary endpoint, which was to significantly increase the proportion of patients who achieved complete remission by adding Genasense® to standard chemotherapy compared with patients treated with chemotherapy alone. With 5-years of followup, all patients who achieved a major response (either complete or partial remission) on the Genasense® treatment arm achieved superior survival compared with responders treated with chemotherapy alone. A decision from CDER is expected in the current quarter.

http://www.genta.com/index.php?optio...23&SHID=&COID=

What was the real reason for non-approval on December 3, 2008? Genta clearly met both requests from the FDA. I think the wording from the FDA is important here. "Not approvable in its current form" very well could be as simple as a clerical error that was addressed by Genta and FDA leadership prior to the appeal being submitted.

Genasense in CLL may stand a better chance for approval this time around than I previously thought.