Replies to post #55521 on Genta, Inc (fka GNTAQ)

[BANKERB]

Before it can be approved-

1. Got to finish the PII trial. (+/- 1 yr)

2. Evaluate the data (3-6 months)

3. Design PIII trial (6-12 months)

4. Conduct PIII Trial (2-4 years)

5. Evaluate the data (3-6 months)

6. Submit the data to the FDA for approval (NDA)

7. FDA has 6-12 months to respond.

I do agree with you that the process is lengthy however I disagree with you on the time frame. From the conference I just listened to Ray said FDA approval(s)within 3 years and projected launch of Tesetaxel in 2015. Ray also mentioned that they have completed the end of phase II meeting with the FDA so Phase III should be coming soon. In fact in one of the countries they have already started accruing patients for phase III. As far as the trial design for phase III goes Ray said that after much regulatory discussion they have agreed upon the final trial design so you can remove #3 from your list since it is complete. As far as points 6 & 7 go GENTA has already applied for FDA Special Protocol Assessment. If that is granted then that will cut FDA response time in half.

Banker