This puretech file is old, isn´t it? Their initial plan for the last trial was to begin in 2016, but they are delayed and they haven´t started yet. They said in the webcast they will start within the next 12 months. So we will see a potential treatment at least one year later.
Update: Follica's Presentation At The 2017 Aad Meeting
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They could possibly use safety and efficacy data from Japan, or any country where certain protocols are adhered to, and submit to FDA, yes.
https://www.fda.gov/RegulatoryInformation/Guidances/ucm126426.htm
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thomps1523
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So that being said if sheisido were to get licensing ability from replicel to distribute in the US, they could hypothetically file a petition to the FDA to allow them to take advantage of the 21st century cures act, and have this available in America a few months after it is available in Japan?
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Btw
"The appropriate category of product (medical device, drug or biologic) is determined by the primary mode of action of the product. Follica’s lead product candidate operates primarily by its TCP device. Drugs already in receipt of FDA approval will be used in conjunction with Follica’s TCP device without change to their route of delivery or indication. Therefore, Follica’s lead product candidate is anticipated to be regulated as a medical device. Assuming a successful read-out of its next clinical study (i.e. after demonstrating that Follica’s lead product candidate can stimulate cosmetically significant hair growth through TCP and at-home application of an approved drug) Follica expects to seek regulatory approval in the US in late 2017."
It's very simple they go for 510K approval and the drug(s) used will be drug(s) that are already on the market.
Two very logical compounds are minoxidil and PGF2a (latanoprost) to me as both are off-patent and the strongest hair growth modulators.
I'm actually almost certain that it's minoxidil though since they mention there is no change of route of delivery or indication (FDA dodge obviously
).
That's not to say that they eventually might research novel compounds but as we know that will take many many years, because new drug applications will go need through the FDA loop and the painstaking costly long process.
@occulus
"The appropriate category of product (medical device, drug or biologic) is determined by the primary mode of action of the product. Follica’s lead product candidate operates primarily by its TCP device. Drugs already in receipt of FDA approval will be used in conjunction with Follica’s TCP device without change to their route of delivery or indication. Therefore, Follica’s lead product candidate is anticipated to be regulated as a medical device. Assuming a successful read-out of its next clinical study (i.e. after demonstrating that Follica’s lead product candidate can stimulate cosmetically significant hair growth through TCP and at-home application of an approved drug) Follica expects to seek regulatory approval in the US in late 2017."
It's very simple they go for 510K approval and the drug(s) used will be drug(s) that are already on the market.
Two very logical compounds are minoxidil and PGF2a (latanoprost) to me as both are off-patent and the strongest hair growth modulators.
I'm actually almost certain that it's minoxidil though since they mention there is no change of route of delivery or indication (FDA dodge obviously
).That's not to say that they eventually might research novel compounds but as we know that will take many many years, because new drug applications will go need through the FDA loop and the painstaking costly long process.
@occulus
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My god I really hope there is minoxidil in there compounds...Btw
"The appropriate category of product (medical device, drug or biologic) is determined by the primary mode of action of the product. Follica’s lead product candidate operates primarily by its TCP device. Drugs already in receipt of FDA approval will be used in conjunction with Follica’s TCP device without change to their route of delivery or indication. Therefore, Follica’s lead product candidate is anticipated to be regulated as a medical device. Assuming a successful read-out of its next clinical study (i.e. after demonstrating that Follica’s lead product candidate can stimulate cosmetically significant hair growth through TCP and at-home application of an approved drug) Follica expects to seek regulatory approval in the US in late 2017."
It's very simple they go for 510K approval and the drug(s) used will be drug(s) that are already on the market.
Two very logical compounds are minoxidil and PGF2a (latanoprost) to me as both are off-patent and the strongest hair growth modulators.
I'm actually almost certain that it's minoxidil though since they mention there is no change of route of delivery or indication (FDA dodge obviously
That's not to say that they eventually might research novel compounds but as we know that will take many many years, because new drug applications will go need through the FDA loop and the painstaking costly long process.
@occulus
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Correct yeah the trial was supposed to start in late 2016 but now it will start somewhere later in 2017. So add a year up to that story.
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This is the first time I have read this information actually. Through logical reasoning my prediction was minoxidil.
But knowing this information straight from them it's actually almost certain it's minoxidil.
I meant to say I hope there isn't minoxidil in there compounds lol that would be such a disappointmentThis is the first time I have read this information actually. Through logical reasoning my prediction was minoxidil.
But knowing this information straight from them it's actually almost certain it's minoxidil.
This is the first time I have read this information actually. Through logical reasoning my prediction was minoxidil.
But knowing this information straight from them it's actually almost certain it's minoxidil.
Why is that bad news? Obviously their treatment is better than just minoxidil alone or they wouldn't spend decades developing this lol
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Was thinking about this..
I'm fairly sure that Follica procedure will simply consist of a device that will disrupt the skin in a form of microneedling at an appropriate depth in office. Not dermabrasion.
Then you will get a fancy applicator at home where you can load their topical in that consists of minoxidil.
Everything makes sense now. You'll see.
R. Dhurat deserves all credit. Yeah he did show that minoxidil + microneedling is better than minoxidil alone.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746236/
Follica will be nothing more than this, just a bit fancier.
I'm fairly sure that Follica procedure will simply consist of a device that will disrupt the skin in a form of microneedling at an appropriate depth in office. Not dermabrasion.
Then you will get a fancy applicator at home where you can load their topical in that consists of minoxidil.
Everything makes sense now. You'll see.
R. Dhurat deserves all credit. Yeah he did show that minoxidil + microneedling is better than minoxidil alone.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746236/
Follica will be nothing more than this, just a bit fancier.
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yeah so how long till the f*****g thing comes man??????? 5 years?
I don't think minoxidil will be in the compound I really don't think so if I'm wrong that would suck. But they patented FGF-9 promotes hair neogenesis after woounding so im hoping its that and maybe Latanoprost
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FGF9 certainly not, zero chance. Latanoprost maybe, but unlikely to be honest (due to regulations). But yeah latanoprost is an option.
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No need to wait. You can already do it. Microneedling + minoxidil brah. Check R. Dhurat study.
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Brutal. Trust me. It's going to be exactly that. Use logical comprehension and you'll understand it. Especially after reading that particular document.
"There is also a clinical study conducted by a third party academic group which validates the approach that Follica plans on pursuing, which the Directors believe is covered by Follica’s intellectual property. The company is currently planning a fourth human study to begin in 2016."
Lol, follica even thinks that R. Dhurat study falls under their IP.
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i wish i possessed those abilities my balding friend
