Announcement

Collapse
No announcement yet.

Seems like nothings happening....

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    #91
    Originally posted by Jim View Post
    Tumbleweeds, the FDA IND process is very straightforward. Wise & team met with them for a Pre-IND meeting in Jan of '16. They told us what they wanted, followed by a negotiation, and an agreement. We then submitted a protocol for the safety studies agreed to. It was several months before they got back to us with the ok to start the study. I believe we started in July. These are long term studies which are nearly complete. We will soon submit the results and wait to hear back from the FDA. It is my understanding that we can not do anything to plan for the trial, until it is approved by the FDA.

    India and Taiwan are both ahead of us, should start in a few months. All the results combined, if positive, will make a strong case to go ahead with a phase III.
    Thanks Jim. So when we start is entirely in the hands of the FDA. Ugh. I try to be optimistic, but that's not very confidence inspiring.

    Comment


      #92
      just shank my Spinal cord with some already! Hah
      "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


        #93
        It's always politics that affect us ... and here we are again a decade after Dubya with Trump cutting the NIH. This is why I insist we separate ourselves from the word, "disabled," as it denotes permanency.

        We must become known as 'treatable.' It's the only way to get over being the small crowd that no one cares about.
        Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

        T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

        Comment


          #94
          With the robust increases to the NIH Obama made and the Can Do attitude of Trudeau you would have thought that all medical problems would be cured by now!

          Comment


            #95
            let's not steer this conversation into the little political shitshow, that already has a forum...in other news, does anyone have any idea on where invivo Therapeutics is with their project for chronics. I mean I got their newsletter today and it seems like things are moving along smoothly with their INSPIRE trial for acutes but when do we get positive news concerning chronics and invivo ?
            "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


              #96
              Originally posted by lynnifer View Post
              It's always politics that affect us ... and here we are again a decade after Dubya with Trump cutting the NIH. This is why I insist we separate ourselves from the word, "disabled," as it denotes permanency.

              We must become known as 'treatable.' It's the only way to get over being the small crowd that no one cares about.
              At this point the decision and delay is at the FDA, not the funding of the NIH. I see info on what Taiwan, Norway, India and China are doing to help us. Maybe I've missed it, but where's Canada's contribution in these trials?

              Comment


                #97
                The research that I would like an update on is Jerry Silver and his lab. Were they able to start the large animal study? Things of that nature.

                My biggest problem with a lot of the research going on is they are terrible about keeping people involved about their process/progress. Monthly press releases on social media wouldn't be hard to do. They don't need to give results if that's not allowed, but an update that says "this is what we did this month, and this is what we will be focusing on in the near future..." would go a long ways in getting people to be more involved and increase funding.

                Comment


                  #98
                  Originally posted by nphuskers View Post
                  The research that I would like an update on is Jerry Silver and his lab. Were they able to start the large animal study? Things of that nature.

                  My biggest problem with a lot of the research going on is they are terrible about keeping people involved about their process/progress. Monthly press releases on social media wouldn't be hard to do. They don't need to give results if that's not allowed, but an update that says "this is what we did this month, and this is what we will be focusing on in the near future..." would go a long ways in getting people to be more involved and increase funding.

                  What irks me is that this or slight variations of this have been said many times to not much avail, most just gave up asking like "it will come when it comes"
                  "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


                    #99
                    Originally posted by nphuskers View Post
                    The research that I would like an update on is Jerry Silver and his lab. Were they able to start the large animal study? Things of that nature.

                    My biggest problem with a lot of the research going on is they are terrible about keeping people involved about their process/progress. Monthly press releases on social media wouldn't be hard to do. They don't need to give results if that's not allowed, but an update that says "this is what we did this month, and this is what we will be focusing on in the near future..." would go a long ways in getting people to be more involved and increase funding.
                    If you mean dogs by large animals, that has already been done and I think published but I am not sure. What I remember is very little improvement but this was a safety study so it was definitely safe. They have plans for different kind of trials but the rest I don't know.

                    Comment


                      Originally posted by scimike View Post
                      If you mean dogs by large animals, that has already been done and I think published but I am not sure. What I remember is very little improvement but this was a safety study so it was definitely safe. They have plans for different kind of trials but the rest I don't know.

                      That was the Iowa State trial with Dr. Jeffery. They used a different form of Chondroitinase (or delivery method). Here is what Silver wrote in a different thread

                      "There are substantial differences in what we are attempting to do. The Iowa state strategy involves a heat stable chondroitinase whose residence time within the cord is perhaps a few weeks. Once the enzyme looses activity the scar and net proteoglycans return. Using the viral delivery strategy, the enzyme spreads over much further distances and is stable for as long as is required (a year or more if needed) and can then be turned off. In addition, the peptide overcomes proteoglycan mediated inhibition far beyond that which the enzyme eliminates. Again, the peptide can be delivered for as long as is needed. The "double whammy" maximally overcomes the inhibition brought about by proteoglycans throughout the spinal cord."

                      Comment


                        I had no idea about these differences. Thanks for the info nphuskers.

                        Comment

                        Working...
                        X