Update: Follica's Presentation At The 2017 Aad Meeting

[Swoop]

:\ Sad, it's always delayed....we have to find ourselves what is the topical they use in order to do this follicle neogenesis

It's likely you'll find out the "topical" or "active ingredient" when their study is up.

 

[Swoop]

This last trial will take how much time?

Probably around a year. Closest release you are looking at now is 2019/2020. That is if everything goes smooth with the FDA and the data is actually favorable.

 

[br1]

But, they already got nice boxes and logos.

LMAO

 

[JuliAN90]

2019/2020 we can just get tsuji treatment and do not need follica anymore Really sad. Let´s just hope for Brotzu, really last hope until 2020. Replicel won´t be a solution for high norwoods.

 

[That Guy]

2019/2020 we can just get tsuji treatment and do not need follica anymore Really sad. Let´s just hope for Brotzu, really last hope until 2020. Replicel won´t be a solution for high norwoods.

If it comes out in 2020: it will only be in Japan, they said they aim to treat just 10,000 people globally and it will definitely cost a fortune.

Follica and conventional treatments will be relevant for a very long time. In fact, I'd wager that I'll be old by the time a NW7 will have easy access to and can afford a next-generation hair transplant.

 

[JuliAN90]

True, sure I am happy if they bring something to market and follica itself too for sure, because they could make more money as a single player on the market. But still, I was hoping for an earlier release.

But now what do we have?
it is really depressing waiting another 4-5 years for any treatment

I really hope fidia is just having stability problems .......

 

[hairblues]

True, sure I am happy if they bring something to market and follica itself too for sure, because they could make more money as a single player on the market. But still, I was hoping for an earlier release.

But now what do we have?
it is really depressing waiting another 4-5 years for any treatment

I really hope fidia is just having stability problems .......

I'm sorry but where are you getting possible release dates?

Has the company said this?

Or are people speculating?

 

[Swoop]

The average Phase III trial last 17 months, and Follica hasn't even started yet. There's no way they release in 2019.

It isn't going to be a phase 3 trial in the traditional sense like you think. They'll be aiming for 510K FDA approval. It's a medical device after all.

 

[CharAblaze]

It isn't going to be a phase 3 trial in the traditional sense like you think. They'll be aiming for 501K approval. It's a medical device after all.

But what about their compound?

 

[Swoop]

But what about their compound?

There isn't going to be any novel compound. It has to be a compound that is already approved on the market due to obvious reasons. Most likely one or more that are off-patent (could be a combination of compounds)

Not if there's a novel compound involved. Do you have a source for that?

Sure: http://puretechhealth.com/images/investors/Puretech_Pi_e-Prospectus_Final_T08_CNB-v2.pdf

"Thereafter, Follica plans to seek FDA 510(k) clearance using data from a pivotal clinical trial at multiple clinical sites within and potentially also outside the US. The pivotal trial for the in-office procedure is expected to be initiated during 2016 and would be expected to complete in 2017"

 

[thomps1523]

There isn't going to be any novel compound. It has to be a compound that is already approved on the market due to obvious reasons. Most likely one or more that are off-patent (could be a combination of compounds)



Sure: http://puretechhealth.com/images/investors/Puretech_Pi_e-Prospectus_Final_T08_CNB-v2.pdf

"Thereafter, Follica plans to seek FDA 510(k) clearance using data from a pivotal clinical trial at multiple clinical sites within and potentially also outside the US. The pivotal trial for the in-office procedure is expected to be initiated during 2016 and would be expected to complete in 2017"

If sheisido shows solid efficacy, why can't replicel utilize the 21st century cures act to release early in America? Have they done any phase trials in America, or have they only done them in BC?

 

[ForeverBald]

If it comes out in 2020: it will only be in Japan, they said they aim to treat just 10,000 people globally and it will definitely cost a fortune.

You mean 10,000 people per year?

 

[That Guy]

If sheisido shows solid efficacy, why can't replicel utilize the 21st century cures act to release early in America? Have they done any phase trials in America, or have they only done them in BC?

Shiseido will show solid efficacy because it's the same tech as RepliCel and RepliCel can't utilize the 21st Century cures act because RepliCel has the organizational skills and punctuality of a one-eyed man with cataracts charged with alphabetizing the Hogwarts' Library and who also has no fuckin' legs to get there anyway.

You mean 10,000 people per year?

That's what they said in the interview this site did with Organ Tech.

 

[Royaume]

@That Guy H2 means that Shiseido is going to release data the earliest in June 2018??

Some users said they expect data in the beginning 2018?

 

[thomps1523]

Shiseido will show solid efficacy because it's the same tech as RepliCel and RepliCel can't utilize the 21st Century cures act because RepliCel has the organizational skills and punctuality of a one-eyed man with cataracts charged with alphabetizing the Hogwarts' Library and who also has no fuckin' legs to get there anyway.



That's what they said in the interview this site did with Organ Tech.

Haha! Maybe I don't understand the FDA well enough, but even tho it's the same tech doesn't replicel have to do trials in the USA to get FDA clearance? So even tho efficacy works in Japan with sheisido, aren't they required to go through phase two in America as well before utilizing the 21st century cures act? Have they even done a single trial in the US, or has it only been in other countries so far?

 

[SamFT]

Shiseido will show solid efficacy because it's the same tech as RepliCel and RepliCel can't utilize the 21st Century cures act because RepliCel has the organizational skills and punctuality of a one-eyed man with cataracts charged with alphabetizing the Hogwarts' Library and who also has no fuckin' legs to get there anyway.



That's what they said in the interview this site did with Organ Tech.

So only 10000 people a year will get the treatment or only 10000 ever? Im so confused

 

[thomps1523]

So only 10000 people a year will get the treatment or only 10000 ever? Im so confused

They're projection is 10,000/year I assume till they can scale it better

 

[SamFT]

They're projection is 10,000/year I assume till they can scale it better

Ohh okay that sounds about right I was gonna be pissed if they only did 10000 ever lol but hey guys if u win the lotteey ill be glad to pay for all of your hair transplants with Tisujii

 

[SamFT]

There isn't going to be any novel compound. It has to be a compound that is already approved on the market due to obvious reasons. Most likely one or more that are off-patent (could be a combination of compounds)



Sure: http://puretechhealth.com/images/investors/Puretech_Pi_e-Prospectus_Final_T08_CNB-v2.pdf

"Thereafter, Follica plans to seek FDA 510(k) clearance using data from a pivotal clinical trial at multiple clinical sites within and potentially also outside the US. The pivotal trial for the in-office procedure is expected to be initiated during 2016 and would be expected to complete in 2017"

This information is making it so confusing so then are we expecting it to be completed or did they not even start? Lol

 

[SamFT]

Also did anyone read the Information in page 108 about follica!? "FGF-9 promotes hair follicle regeneration after wounding" So its pretty safe to say FGF-9 is one of the compounds??