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    It's all gone rather quiet re the China trial. I just hope it's the calm before the storm. I can't wait to see the official results of this trial.

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      Calm before the storm is a pretty much right on.

      Can't wait until published and the mountain of data is available to everyone.

      Comment


        Originally posted by Jim View Post
        Calm before the storm is a pretty much right on.

        Can't wait until published and the mountain of data is available to everyone.
        Do you know when that will be ?Jim
        "That's not smog! It's SMUG!! " - randy marsh, southpark

        "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


        2010 SCINet Clinical Trial Support Squad Member
        Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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          I don't know how much time it takes to publish a paper once submitted.

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            so the paper has already been submitted ?Waiting for publication?Or no?
            "That's not smog! It's SMUG!! " - randy marsh, southpark

            "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


            2010 SCINet Clinical Trial Support Squad Member
            Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

            Comment


              Don't think submitted yet.

              Comment


                Originally posted by Jim View Post
                I don't know how much time it takes to publish a paper once submitted.
                6 month is not uncommon. there is time for peer review and the author's response to peer comments. journals typically show three dates - submitted, accepted, and published. The Harkema paper with the excellent estim results was submitted September 2013 and just published in April 2014.
                T5/6, ASIA A, injured 30 Nov 08
                Future SCI Alumnus.
                I don't want to dance in the rain, I want to soar above the storm.

                Comment


                  All I know is that the FDA must respond in a set amount of time. I can't remember offhand, but if you follow any of the spinal cord injury therapeutic biotech companies – they announce when they are submitting and when they receive information… Everything is available on their website to keep investors and consumers aware.

                  I think it is easy to keep track of news and progress when a company is public. I imagine a foundation could manage their pr in the same capacity.

                  Comment


                    Jim, check http://www.accessdata.fda.gov/script...21:5.0.1.1.3.3

                    It probably is different for a specialized drug, biomaterial or medical device. But there's tons of information here maybe you could find your answer

                    Comment


                      Thanks Chaz!

                      Comment


                        6 more months HAHAHAHAHAHAHAHAHAHAHAH been hearing the same Fu****** thing since I first heard of it in 2011 when I was first hurt & met Dr.wise in person in Detroit, mi .

                        Comment


                          To the moderators: Please move my posts # 1881 & 1888 to a new thread: 'Unanswered and/or Ignored questions' to ChinaSCINet Update'

                          I don't see no point in having an open update tread since questions are ignored, nothing new has been posted for several months and everything’s so quiet...
                          Last edited by Moe; 15 Apr 2014, 4:28 PM.
                          "Talk without the support of action means nothing..."
                          ― DaShanne Stokes

                          ***Unite(D) to Fight Paralyses***

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                            Wise's answer to you dated 3/18/14- http:///forum/showthread.php?229975-...=1#post1725376

                            Originally posted by Wise Young View Post
                            The US FDA as well as the EMA (European Medicine Agency) both require that two phase III trials show similar positive effects before they will approve treatments. So, two phase III trials as essential for approval in at least the U.S. and Europe. If we are able to get two phase III trials going in these countries, this means that we can get virtually global approval of the therapy in one year. We want to do both trials in parallel. Doing the trials sequentially may take twice or three times as long.

                            Regarding the time required for entry and analysis of the data and the writing of the papers, these are very complicated studies and involve hundreds of thousands of data points concerning the therapies, HLA-typing, viability, patient data, outcome data, adverse events, medication, etc. Most of the past fall was spent verifying the data and making sure that that database is working. The main outcomes database was not closed until this January. We are working on this as hard as we can.

                            In addition, we are working very hard preparing the applications (IND) for the trials, finding the funds for the trials, and setting up for the upcoming trials. A lot of the work is aimed at collecting the documents required for IND applications, regarding cell preparation and validation, safety, and procedurs. IND applications are typically thousands of pages in length. We are transferring technology so that the cells can be prepared in China.

                            Finally, the fundraising has not been trivial. We are patching together funds from many sources. All of this is going on at the same time.

                            Wise.

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                              台灣 病人 如何 在註冊 臨床試驗 呢?

                              Comment


                                Originally posted by gn00553853 View Post
                                台灣 病人 如何 在註冊 臨床試驗 呢?
                                你 看过 这 个 网 址 吗?
                                http://www.chinascinet.org/index.php...d=129&lang=cht
                                Debating on CareCure is like participating in the special-olympics. You may win, but you're still disabled.

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