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    #16
    Originally posted by DA View Post
    i was thinking if what they were seeing in china wasn't good results, then why do it here.
    Why assume that the Chinese trials didn't yield good results?

    Wise seemed satisfied with the data. They've only done safety stuff so far. The efficacy phase has not even begun.

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      #17
      If the efficacy phase hasn't been done yet, isn't that phase I in "clinical trial" language? I was assuming that the trials were yielding good results to start a phase III trial here. Isn't there four phases to go through before possible FDA approval? I just want to make sure I have the order right, etc. Is there going to be anyone posting about this event? Thanks for all the info.

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        #18
        Originally posted by momo3 View Post
        If the efficacy phase hasn't been done yet, isn't that phase I in "clinical trial" language? I was assuming that the trials were yielding good results to start a phase III trial here. Isn't there four phases to go through before possible FDA approval? I just want to make sure I have the order right, etc. Is there going to be anyone posting about this event? Thanks for all the info.
        There's usually three phases, but sometimes four are needed.

        Thankfully, there are sometimes Phase I/IIa trials like what Geron is doing, which focuses on a combination of safety and efficacy. If all goes well, only one additional trial will be required for FDA approval.

        If all goes extremely well, the FDA can approve the treatment on a compassionate-use basis while the second (and possibly third) trial is ongoing.
        ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

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          #19
          This is great news... and a long time coming.
          Let's speed it up.
          What do you need Dr. Young? Lots of coffee? Let's hook it up. I'll ship you Tim Hortons! It's coffee on crack!

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            #20
            Okay, now I finally understand. Here is hoping for trials that go extremely well.

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              #21
              Originally posted by DA View Post
              i was thinking if what they were seeing in china wasn't good results, then why do it here.
              Poke, poke. It's phase 3 here in the U.S. It will go at about the same time as the phase 3 will be done in China. The US FDA requires two phase 3 trials before they will approve a therapy.

              Wise.

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                #22
                Originally posted by jhope View Post
                I couldn't imagine what it would be like to spend my life trying to help debilitated people. To spend years, long hours of the day well into the night, and traveling to the far reaches of the earth meeting with other scientists, reading their data. Then return to those people and bring hope, answering all of their questions good and idiotic with kindness and understanding. Only to have a few of those people spit in my face with doubt, mistrust, negativity and spite. Tell us what that's like Dr. Young.
                Wow, I was thinking the same thing.
                get busy living or get busy dying

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                  #23
                  Originally posted by Wise Young View Post
                  Poke, poke. It's phase 3 here in the U.S. It will go at about the same time as the phase 3 will be done in China. The US FDA requires two phase 3 trials before they will approve a therapy.

                  Wise.
                  DA stuck his foot in his mouth this time.....lmao

                  Art
                  Art

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