It was a different short thread and I can't remember how to find it.
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We are currently conducting the studies the FDA required for approval. When complete and approval is granted, recruitment will begin. Last I heard, will be next year.
Taymas, evidence suggests that just a fraction recover with the 6-6-6 program alone. One of the groups in the IIb trial will be 6-6-6 only.
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Originally posted by Jim View PostWe are currently conducting the studies the FDA required for approval. When complete and approval is granted, recruitment will begin. Last I heard, will be next year.
Taymas, evidence suggests that just a fraction recover with the 6-6-6 program alone. One of the groups in the IIb trial will be 6-6-6 only."Talk without the support of action means nothing..."
― DaShanne Stokes
***Unite(D) to Fight Paralyses***
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Hola Moe, nothing has been done in China because the govt put a freeze on trials while creating new policies. Last I heard, India will be starting first, prob this year. In the US, we are conducting the animal safety studies the FDA required for approval, will be done this year, then much to do before recruitment. Norway, still in the works. I believe more workshops are necessary, Wise has been too busy to get back there.
I know it is taking a long time, but I can't tell you how hard it is to make theses trials happen, money, and all the roadblocks happening in the background make it a huge challenge. Once the India and US trials launch, the foundation will be set and progress speed up.
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Originally posted by Lyerly View PostSo you need animal trials here, when you have information and data on humans in other countries. Sounds like some amazing collaboration and use of time and money.
IMO this is exactly what we need in the US to speed up the approval process at the FDA and help eliminate the redundancy of repeating studies that have already been done and proven overseas. It would greatly benefit us all.
These kind of policies need to be encouraged.
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Originally posted by tumbleweeds View PostThis post is about the FDA, I don't mean to inject politics into this thread, but since the FDA is a government agency I wanted to mention that Ted Cruz said if he were elected president (yes, I know it's a moot point now as the primaries are over, but he is still a Senator) that any therapy, medicine, procedure, or medical equipment that has been approved, and proven safe, in foreign countries but is not available in the USA, the FDA would be given 30 days to approve it or the issue/item would be put before congress for an up/down vote.
IMO this is exactly what we need in the US to speed up the approval process at the FDA and help eliminate the redundancy of repeating studies that have already been done and proven overseas. It would greatly benefit us all.
These kind of policies need to be encouraged.
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Originally posted by Lyerly View PostSo you need animal trials here, when you have information and data on humans in other countries. Sounds like some amazing collaboration and use of time and money.
For the record I have lower motor neuron damage so this treatment along with others isn't anything that will benefit me anytime soon. Just the more I learn about research the more confused and frustrated I become. While I think there are some people that really want to help us, I do see a huge lack of collaboration and possibly people wanting to make sure that it is their work and their work alone that did it. Probably has to do with competing for funding as well.
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Originally posted by Lyerly View PostYes, I should have made it more clear that this was not a jab at wise it was me not understanding and frustration with FDA requiring it. I assume to even get to Phase II in China, animal studies were already conducted. So why repeat? Was a any patients treated with only the 6/6/6 or did they all receive cells and lithium?
For the record I have lower motor neuron damage so this treatment along with others isn't anything that will benefit me anytime soon. Just the more I learn about research the more confused and frustrated I become. While I think there are some people that really want to help us, I do see a huge lack of collaboration and possibly people wanting to make sure that it is their work and their work alone that did it. Probably has to do with competing for funding as well.
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You pretty much hit the nail on the head. It frustrates the hell out of me as well, it honestly makes me livid sometimes. I am in the second year of getting my PhD, and we young students hear all the time about how it's important to publish in high impact journals, to present at conferences, to get awards, to get grants...I have not once heard about how it is important to do research that makes an impact towards an ultimate goal (like curing SCI). Scientists must compete for funding as part of their jobs, and often times competing for funding undermines the integrity of the scientific work itself.
In a lot of disease populations, SCI included, a lot of researchers look at SCI as an interesting scientific problem, and are not focused on an ultimate goal of making an impact in the lives of people with SCI. This is nothing I fault them for, there are a lot of factors that go into that mentality. But you are right, there is a big lack of collaboration - sometimes this is because of egos, sometimes it is because of a lack of resources, and sometimes there is a lack of understanding about what other scientists can contribute or are trying to accomplish.
IMO, the most important yet least frequent type of collaboration there is, is collaboration between researchers and people who actually have an SCI. More people with SCI need to understand the scientific process, and more researchers need to understand the needs of the SCI population if we want a cure to come faster.
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Originally posted by scimike View PostWhat studies have been done or illnesses been helped or cured and FDA is rejecting it? No general statements.
The Stimulette is a muscle stimulator for those who have lower motor neuron damage and can't use FES to combat muscle atrophy. Last I checked, the stimulette is not FDA approved, and cannot be prescribed by doctors in the USA.
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Originally posted by Lyerly View PostYes, I should have made it more clear that this was not a jab at wise it was me not understanding and frustration with FDA requiring it. I assume to even get to Phase II in China, animal studies were already conducted. So why repeat?
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Originally posted by tomsonite View Posthttp://www.anatomicalconcepts.com/stimulette-den2x/
The Stimulette is a muscle stimulator for those who have lower motor neuron damage and can't use FES to combat muscle atrophy. Last I checked, the stimulette is not FDA approved, and cannot be prescribed by doctors in the USA.
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Originally posted by tomsonite View Posthttp://www.anatomicalconcepts.com/stimulette-den2x/
The Stimulette is a muscle stimulator for those who have lower motor neuron damage and can't use FES to combat muscle atrophy. Last I checked, the stimulette is not FDA approved, and cannot be prescribed by doctors in the USA.
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