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    http://www.youtube.com/watch?v=Snk3W...eature=mh_lolz

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      Many arms waving, legs twitching, grimacing and phrase-mongering. As usual and nothing about research.

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        Originally posted by kivi66 View Post
        Many arms waving, legs twitching, grimacing and phrase-mongering. As usual and nothing about research.
        You expect him to give a scientific break down to what looks like non-scientist?

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          Originally posted by Lyerly View Post
          You expect him to give a scientific break down to what looks like non-scientist?
          I think Kivi and many are looking for results. It's good that the trial is growing and becoming multi-country and multi-continent but everyone wants positive results and they want them now.

          I think published positive results will open the floodgates of funding. Published negative or lack of any positive results will cause the opposite.

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            Originally posted by kivi66 View Post
            Many arms waving, legs twitching, grimacing and phrase-mongering. As usual and nothing about research.
            I think Wise has said many times:
            1. He does not know the results until the data is collected and analyzed from the Phase 3 clinical trials.
            2. If he did know something, it would be unethical to devulge it.


            Frankly, if the trial turned out not to be successful in curing paralysis, he has still accomplished a lot in organizing a network of SCI clinical trial centers. Besides, the funding of most of this work is coming from China, so why are some people acting like they've been cheated out of their life savings? If you want to be cheated, go to one of the stem cell centers in Latin America.

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              And remember, this is a Phase II Safety Study. It is a huge deal that the surgery and injection of cells into the spinal cord is safe. This in itself is a major step forward. Anything else is icing on the cake.

              All of the funding for ChinaSCINet Trials has come from China/Hong Kong.

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                Originally posted by Jim View Post
                And remember, this is a Phase II Safety Study. It is a huge deal that the surgery and injection of cells into the spinal cord is safe. This in itself is a major step forward.
                Such a great point. Never even thought about that.

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                  wise young phase 3 clinical trials in China will be held in the new hospital of doctor hui zhu to kunming

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                    Originally posted by fti View Post
                    wise young phase 3 clinical trials in China will be held in the new hospital of doctor hui zhu to kunming
                    We have not yet made that determination. In order to be eligible to be center for our trials, the hospital must be GCP (Good Clinical Practice) qualified by the sFDA (the Chinese state Food and Drug Administration. The requirements are quite onerous and the sFDA takes a long time to give GCP certification. So, we are not sure whether they will be qualified by next year. Wise.

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                      yet he was qualified for the phases 2 ?

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                        fti,

                        The Phase I & II ChinaSCINet trials were done at the Kunming Army General Hospital under the leadership of Dr. Hui Zhi. She recently had to retire from the Army because of her age and has moved to, I believe, a brand new private hospital to continue the trials there. Because it is a new facility, they have not yet been granted GCP status. Hopefully it will happen soon.

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                          Originally posted by Wise Young View Post
                          We have not yet made that determination. In order to be eligible to be center for our trials, the hospital must be GCP (Good Clinical Practice) qualified by the sFDA (the Chinese state Food and Drug Administration. The requirements are quite onerous and the sFDA takes a long time to give GCP certification. So, we are not sure whether they will be qualified by next year. Wise.
                          So does this mean that phase III trials in china are at a standstill for now?
                          T6 complete since 3/21/2012

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                            Does the delay in China impact the timing of US ones? Is there any idea of when they will start or a timeline or a goal? Specifically the one at Kessler?

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                              There is no delay in the China trials, please don't make assumption because of what others post.

                              The data from the Phase II ChinaSCINet will be available in November. This data will be used to apply to the U.S. FDA for approval. Projected start date is mid 2013, assuming the all the funds are raised. We have a lot of work to do.

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                                Jim, you are like an island of stability in a stormy ocean, good job. And it is interesting, what kind of signal will give your beacon in November.

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