Originally posted by Jim
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Whats up Jim, can we even get an estimate of when the next phase will be published and available to read.... Early April... Late April... Early may... Late may"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!!!! "
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We have been waiting to hear news of a research study for my son. Every month, the answer is "in a month".
Bascially, what I'm saying is, there are no updates because there are no updates. They probably know as much as you do when stuff will get approved. Researchers are good at research...timelines on the other hand...not so much. Should hire some project managers to get this stuff going.
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Has the inclusion criteria for the phase 2b trial with cells for possible spinal cord regeneration been considered to be expanded, because if you get the green light to treat US citizens with C4 injuries... Im most likely there with bells on, that is what I have so anxiously been waiting for... And get this damn syrinx operated on
Whats the word about; when can "I" an American citizen, C456 with a Syrinx approx 14 years post, participate in a cell transplantation trial whether here in the US or abroad if necessary..."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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Hey luna,
We first need to repeat the trial to confirm the results. Safety is still an issue in my opinion. Chinese surgeons have been injecting cells into spinal cords for many years, has never been done in the US. No doubt, our surgeons in the US trial are top notch, but still inexperienced. I have seen the surgery on video, seems pretty easy, but there is always a risk. Personally, I would apply if I fit the inclusion criteria.
If the results are repeated from the HK/China trial, will go ahead with a phase III. At the same time, we can run trials for those with highter injuries, children, those above 65, and incompletes. For those with higher injuries, the surgeons need to decide on the protocol. Basically, where to inject (because of the phrenic nerve).
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Originally posted by Jim View PostHey luna,
We first need to repeat the trial to confirm the results. Safety is still an issue in my opinion. Chinese surgeons have been injecting cells into spinal cords for many years, has never been done in the US. No doubt, our surgeons in the US trial are top notch, but still inexperienced. I have seen the surgery on video, seems pretty easy, but there is always a risk. Personally, I would apply if I fit the inclusion criteria.
If the results are repeated from the HK/China trial, will go ahead with a phase III. At the same time, we can run trials for those with highter injuries, children, those above 65, and incompletes. For those with higher injuries, the surgeons need to decide on the protocol. Basically, where to inject (because of the phrenic nerve).
Is it even reasonable to ballpark a guesstimate on approx when... 3 mo, 6 mo, a year.... I know predicting timelines was known to kind of blow up in your face in the past but is it possibly different now"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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Originally posted by Jim View PostBro, ain't touching a timeline!
I will say, once we get this trial going, there won't be as many delays. The main obstacle going forward will be funding, but Wise has a solid plan.
Haha I understand that"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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For further reference....
Originally posted by Moe View PostTimelines and predictions keep getting postponed these past 3-4 years, feels like nothing new since then.
Originally posted by Moe View PostI notice this exact phrase has been said every beginning year for the past 4-5 years... sadly I'm getting the feeling that in another 5 years it will still be the same...
Originally posted by Moe View PostMy hopes in these trials are pretty much faded out by now. All predicted dates seem to never work out for years and the so-called 'significant recovery' in participant from passed phase II in China are not even followed-up with a reason that the participated live "too far" (within China btw) to collect data, but yet think to be able to manage further countries like US, India, Norway... Really I don't get it.
Now seems nothing predicted is not going to happen again this year except maybe in the US when the FDA application goes through which I can't understand again how can trail dates be predicted in the US if the application hasn't even been submitted yet.
Happy 7th anniversary ChinaSCINet Update thread.
I'm pretty much done here - Thanks for all the hard work and effort the same.
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