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interstate

01/29/12 11:47 AM

#39092 RE: rocky301 #39089

Rocky,

"Yes, we used the single-cell biopsy method (but we discarded the embryo afterwards). However, we have several hESC (human embryonic stem cell) lines where the embryos were not destroyed -- we plan to switch to those hESC lines in future (phase 3/4) clinical trials."



Is there any way the FDA will let them do this without restarting the whole trial. I thought they had to stick with MA09 though out the trials since all the animal studies and pre-clinical trials used MA09. There is no way the FDA will let them use the other lines without simlar test. IMO

Titan V

01/29/12 2:38 PM

#39102 RE: rocky301 #39089

Rocky, thanks for the clarification and also for the link.