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Hmmm I'm like almost fairly certain the whole reason there was a hold up was because he changed the design and had to present this change to the fda.
I read the quote mate haha. I really don't want to scroll back through the pages to find it but I'm certain it's all been approved. It's not the same as drugs.
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He's already shown the fda that the technique works. The hope between all use is that you can do donor multiplying. But that doesn't need to be proved at all in terms of fda. The delay was a change in design to the tools used but now it's been cleared.
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Originally Posted by lacazette
But if it wasn't FDA approved, he couldn't clinicaly use it to test small sessions on some of his patients no?
He already done clinical trials with FDA conditions, and now it sounds more like a "real world" trial for me, without FDA supervision or whatever
these small sessions will most likely comprise part of the FDA clearance process. real world trials are part of that.
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Originally Posted by barfacan
2018.
could be.
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2018 for the begin of becoming the gold standard
but I really hope it will be sooner in Wesley clinic and in a few docs in the world
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Originally Posted by lacazette
2018 for the begin of becoming the gold standard
but I really hope it will be sooner in Wesley clinic and in a few docs in the world
2017 for that.
2018/2019 for gold standard assuming everything goes as planned.
stuff like this simply doesnt happen with a snap of the fingers.
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I think too it's going to be ~2018 for a good one, or even later. Good thing is there are many surgeons that know how to place the grafts now, so they only need to figure out how to extract.
One of these transplants together with replicel/shiseido would be great.
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Originally Posted by Trenblastoise
I think too it's going to be ~2018 for a good one, or even later. Good thing is there are many surgeons that know how to place the grafts now, so they only need to figure out how to extract.
One of these transplants together with replicel/shiseido would be great.
yeah those are some interesting points about graft placement already being in order. i agree. 2017-2018 is when we will really see the show with this (assuming it works as planned in the upcoming trials).
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If Pilofocus doesn't offer a greater amount of hair in the recipient area, this changes nothing.
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