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Originally Posted by DepressedByHairLoss
From what I understood, 2015 is when this will be released in the U.S., but elsewhere it will probably be released sooner. They don't need to jump through these idiotic and unfounded regulatory FDA hurdles overseas so this product will be released much sooner outside North America. Hell, that's why they're doing overseas trials in the first place. BTW, that 20% Propecia figure is total B.S. I've been on Propecia for a while now and I haven't achieved anything close to 20% regrowth, more like 0% regrowth and just slowing down my hair loss. What's good about Replicel is that they're actually trying to regrow a full head of hair through their technology, so their method isn't limited in any way.
hopefully you are right, but he didn't really say that.
he said they will go through all the necessary protocols to show this is a legitimate tx or something of that effect.
was it mentioned in any previous interviews/articles that they would be seeking approval outside of north america?
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Amen to that Tracy. 2015 is way too far away, that's why I'm hopeful that outside North America they won't have to screw around with the FDA and will therefore offer this therapy a helluva lot sooner. I too will be on a plane to anywhere when Replicel's therapy becomes available, nor will I wait for any B.S. FDA approval (which really means nothing to me).
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Originally Posted by dkayla77
was it mentioned in any previous interviews/articles that they would be seeking approval outside of north america?
Yes it was. I don't remember which article or news clip I read or heard it. It was mentioned that the treatment would likely be available outside the U.S. at least 18 months before it will be available in the U.S..
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Originally Posted by Tracy C
Yes it was. I don't remember which article or news clip I read or heard it. It was mentioned that the treatment would likely be available outside the U.S. at least 18 months before it will be available in the U.S..
ok that is hopeful news then....thanks!
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I'm pretty sure Replicels solution will be available outside of the US if they finish Phase II. I know he didn't mention it on TV, but why should he. You know organisations like the FDA, they kind of dont like to get provoked and underestimated. You have to consider his position, someone like Mr.Hall really has to be careful with his statements. He can't claim something withouth being sure about it.
But I am pretty sure it would be a very big relief for everyone of us if their concept is proven.
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So if all goes well and their concept is proven to work, and if they release it earlier outside of the U.S., would that also include Canada? I'm not aware if Health Canada (Canada's medical regulatory body) has the same hang ups with autologous treatments as the FDA does.
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Where would be a good bet for getting this done post phase 2? Somewhere in Eastern Europe? Do Bulgaria and Hungary have to go through the FDA or an equivalent?
Surely Replicel will have the paperwork done and have actually started phase 3 before they go ahead and release it elsewhere. I'm a little bit skeptical of them releasing it before phase 3 is finished. I don't mean to rain on the parade here but I'm thinking mid 2016 seems more reasonable. I know it's the old 5 years away thing but it seems more feasible to me.
They're presentation showed up Aderans a bit since it seems like the DSC cell route is a much better bet than the dermal papillae route.
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