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Re: nmbr1stckpckr post# 31444

Thursday, 04/28/2011 1:25:15 PM

Thursday, April 28, 2011 1:25:15 PM

Post# of 92948
nmbr1,


The NIH redefiniotion to allow our cell lines for FED funding is still in limbo. Just yesterday RABIN addressed the issue

Gary Rabin:
Well first of all right now our cell lines are not eligible for NIH funding, the definition of what would be an expectable cell line is still an open question in the US, and so obviously getting NIH funding would be helpful as we take the next set of therapies into the clinic, but we believe that the regulatory overhang of the embryonic stem cell companies has been eased a lot because of Geron success in getting their human trials to begin and ours to begin as well. It took Geron two-years to get through the agency to get approval to begin their human therapies, it took us one-year for our first but only 30 days for our second, so we think that the FDA is now coming to understand that if you have the proper assays, if you take the proper care that you are not going to inject undifferentiated embryonic stem cells or some short follower to that into a person's body we are focusing on developing therapies that can be used, that are safe from the perspective of teratomas and tumors and all those sorts of things that you might be worried about in undifferentiated cells, so we think the regulatory environment has got in a lot friendlier for us obviously the success of Geron safety trial and the success of our safety trial will raise the profile of this industry, it's an industry that for 10, 15-years there has been so much hope pinned on. In the United States there is this fellow Christopher Reeve who is superman and he had this spinal accident and ultimately died and it was around the time of his spinal accident that people became aware of the opportunities around stem cell science and now just this year 2011 we are actually going to see the reality of these things so it's very excited.
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