7th World Congress for Hair Research (2013)

[jman91]

unfortunately a lot of people on here, myself included, will have most likely progressed too much by the time this is available. Realistically, my hope is that a NW6 could use hist to thicken donor supply so they become a candidate for a ht (hopefully scar-less technology will also be available by then too)

[stayhopeful]

I am down to be a test subject in phase III!! But what about this guys: say that we get some hard irrefutable evidence that Histogen is coming to the market and is effective, AND getting a HT will not interfere... I will be WAY more inclined to Dr. Wesley dense pack my hairline for the interim 2-3 years Histogen is going to take to get to market, knowing that there will be backup on the way... what do you guys think about that strategy?

[rdawg]

say it goes to phase III in north america wouldn't they spread the tests all over country?(or countries if they count canada)

wouldn't mind applying for it.

[Henkeh91]

What do you guys think, does Histogen work on people at NW5-NW6? Not a total coverage of hair but atleast decent coverage.

[Thinning87]

Well we all knew it wasn't gonna be tomorrow guys... this is bittersweet, as 4 years will make a huge difference for me as I will be approaching 29 at that time (holy shit 30 years old is scary...).

Hopefully there is a chance the 48 timepoint yields much better rates of hair growth, not to mention product optimization in phase 2B.

And I have to say I still have some faith in ARI as they may have found a way to move forward finally.

I guess we'll find out in two weeks... goodnight folks...

[rdawg]

It's a huge buzzkill especially if we see this product work well.

Knowing that there's something out there but it's still 3-4 years away!!!

[john2399]

Talk bout being patient!!!! Phase 3 is so pointless. goddam.

[Desmond84]

pretty much

+ 10-12 months for FDA/TGA/EMEA/Japanese approval

[PatientlyWaiting]

Okay, I always see 2b/III mentioned together, I was under the impression that they are done together or something. So 2b will take 1 year, and 3 will take another year and a half?

[ANW]

yes the trials run for about a year, but time is lost in between to get approval to start and recruit and approval once complete.

I believe Dr Zierling and Replicel CEO Hall said in Asia phase 2b/3 can be combined or run back to back. Cant remember which one, we shall know soon.

[Desmond84]

Phase 3 may take anywhere between 6 months to 3 years depending on what condition is being treated!

Hairloss trials generally last 12 months + 6 months to allow for patient recruitment and data analysis.

[Thinning87]

that is a major buzzkill! singapore and Korea aren't exactly close you know haha, pretty rough to spend 2000 bucks to fly over and try this stuff.

but still, why does phase III take longer? isnt it 1 year each?

Oh whatever man if they had this tomorrow I'd spend 20 thousand to fly over to *****ing Korea

[rdawg]

Unfortunately not!

To file for Phase 3, you must complete your Phase 2b trials!

Realistically, for Histogen to become readily available in US/Europe/Japan/Australia, we have to wait till 2017!

There are talks that South Korea and Singapore allow you to combine the number of patients from Phase 2a and 2b trial and make that a Phase 3! This way we may have Histogen available in these 2 countries by late 2015

that is a major buzzkill! singapore and Korea aren't exactly close you know haha, pretty rough to spend 2000 bucks to fly over and try this stuff.

but still, why does phase III take longer? isnt it 1 year each?

[rdawg]

Okay, I see. I just searched what are each phases for and see you are right. It says Phase III takes 3 years, so by 2016 Histogen will be ready to use if gets FDA approved, or more like 2017?

I was under the assumption Phase III takes one year....

IIB starts by summer-fall ends by 2014 fall,phase III starts a few months after that so potentially end of 2015 or early 2016?

I mean if they have efficacy now, and simply plan to expand the injections I cant see them running into funding or product problems, so it should be a smooth trial if it really does work.

[Desmond84]

Unfortunately not!

To file for Phase 3, you must complete your Phase 2b trials!

Realistically, for Histogen to become readily available in US/Europe/Japan/Australia, we have to wait till 2017!

There are talks that South Korea and Singapore allow you to combine the number of patients from Phase 2a and 2b trial and make that a Phase 3! This way we may have Histogen available in these 2 countries by late 2015