Cha Biotech Meeting July 11, 2011 I met with Dr. Kwang Yul Cha, President and Chairman of Cha Biotech on July , 2011 with his assistant Ms. Yuna Lee at Chaum Medical in Gangnam-gu South Korea. Here are the questions and answers for our interview.
1. Is CHA using Frozen Embryos given to it from ACTC for its clinical trials.
Yes
2. Have they been delivered yet?
Yes
3. When will the injections start?
In two weeks.
4. When will there be initial results? In 6 weeks if not sooner, we have to be very careful as the KFDA wants to proceed with Caution.
5. Why, does this have to do with the prior scandals dealing with the cloning results of Hwang Woo-suk. Yes, since these are the first results for Hesc everyone wants positive results and credible and honest trial documentation.
6. Are your safety and efficacy end points the same as ACTC? Yes
7. Is Cha waiting for KFDA approval or has it only been approved by the Bio Ethics Committee. Yes, at the same time.
8. Can Cha use the data from the US Trials to Help with trials in Korea? Yes, but the KFDA wants its own data.
9. Can Cha get compassionate use in Korea? Yes
10. If and when trial results are exceptional can Cha terminate and go to an open Phase III in Combination with Commercialization. We believe we will have positive results and hope that we can move quickly through Phase I/II to provide important information so KFDA will allow us to move ahead to Phase III.
11. How long will that take, can you give us a timeline? initial procedure will take 2 weeks to start injections. immunosuppresants are being administered now, the injections and initial results will be in about 6 weeks. After the 6 weeks we will have to reevaluate the stregnths and dosages to determine exactly what we are going to move ahead with. ie. larger amount of stem cells for the procedure per patient.
12. Will Cha apply for and NPP f0r Orphan Status and a compassionate use program. Yes, we are talking to the KFDA about the ORphan Drug Status and will give there opinion on it by next week.
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