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.
RepliCel - Tobin Smith of Fox News and NBT Equities Interviews CEO David Hall
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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.Leave a comment:
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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.Leave a comment:
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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..Leave a comment:
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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).Leave a comment:
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hopefully you are right, but he didn't really say that.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.
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?Leave a comment:
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Excited is not the word I would use to describe how I feel about it. But I sure am hopeful. As I have said many times before. I am happy with what the current available treatments and my doctor's excellent restoration work have been able to do for me - but I would really love more density.
2015 seems to be a best case scenario - and too far away. However, I am already budgeting money to sock away for a trip to wherever this will be available. I do not plan to wait for FDA approval. I have spent too many nights crying myself to sleep over my hair loss. Wherever I need to go to get it as soon as it is available, that is where I will go.Leave a comment:
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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.Leave a comment:
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If this is in fact the holy grail, let's just hope that their business model isn't to licence it to "big bio" or "big pharma" who will no doubt rape us in the wallet. I would much rather see them extend it to qualified surgeons, and control the pricing.Leave a comment:
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It´s true just stupid to be negative! But it´s hard to bee positive when it comes to hairless treatments.Leave a comment:
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Umm, maybe I mis-heard the interview or maybe I can't add up but I make it more like just over 3 years. We're nearly in 2012 and he said earliest 2015 not 2017. I know there's no promise that it will be 2015 but that is what he said. My whole point is why be negative and add years on for the sake of it.Sounds good! But itīs still very hard to know that a solution is at least 5 years away!
Still i canīt stop hooping that i still have some hair left when the "saving" is here!
What a awesome feeling it must be to wake up and knowing that iīm going to keep my hair for a longtime!!Leave a comment:
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Sounds good! But itīs still very hard to know that a solution is at least 5 years away!
Still i canīt stop hooping that i still have some hair left when the "saving" is here!
What a awesome feeling it must be to wake up and knowing that iīm going to keep my hair for a longtime!!Leave a comment:
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RepliCel is moving in and moving FAST! Hopefully this exceeds expectations.Leave a comment:
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I hadn't seen the mouse ear photos before, that's pretty impressive, even more so than Histogen. I realize it's still a mouse but it still looks good.Leave a comment:
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