Aderans

[Desmond84]

Wow, Boldy thx for all this great info! It's definitely good to see you share my opinions on DP!

I was starting to give up with ppl being so negative

I'm gonna be reading all these studies you linked today! We'll have a thorough discussion in the next few days

Welcome to BTT brother! We need ppl like you desperately

[Jasari]

If this ends up being the case there will still be hl forums and depressed guys everywhere because modern ht density still looks very bad. if all we are hoping is that histogen and the others do is halt your hair loss at say nw 4 so you feel safe to use all your donor on an ht you will still look very very thin.

I thought we were being told that histogen was regrowing quite a bit of hair not just halting progression. so we've given up on them being able to cause regrowth of 40 hairs/cm2 ?

IMo the only way these treatments really become game changers is for people to be able to have ht and then histogen injections and add 40plus hairs per cm/2 on top of ht density. just my opinion.

Virtually any norwood 4 or 5 would have a seemingly thick head of hair if they used their donor without having to worry about further loss.

[Boldy]

Where did you read that at? That would be amazing!!

Read this post. this information is from cotseralis study.
this posts contains also the full study for reference.

http://www.baldtruthtalk.com/showpost.php?p=99370&postcount=527

The future looks indeed very hopefull !

check also this topic:

http://www.hairlosshelp.com/forums/messageview.cfm?catid=7&threadid=103913&enterthread=y

[FearTheLoss]

I don't think propicia is needed with injected Dermal papillae cells, since these cells are not prone to DHT/ androgens.

I hope they speed up the trials !

Where did you read that at? That would be amazing!!

[Boldy]

Yeah but those results were at 12 and 24 weeks after one set of injections...then they did two sets and got better results..I'm guessing now in phase III they will do more and see where that goes..the vellius hairs will turn to terminal and with the addition of propecia one could hope for even much better results!

I don't think propicia is needed with injected Dermal papillae cells, since these cells are not prone to DHT/ androgens.

I hope they speed up the trials !

[FearTheLoss]

It is regrowing hair; vellius hair.

Yeah but those results were at 12 and 24 weeks after one set of injections...then they did two sets and got better results..I'm guessing now in phase III they will do more and see where that goes..the vellius hairs will turn to terminal and with the addition of propecia one could hope for even much better results!

[Thinning87]

Thinning just read it brother...

if its early stages I reckon just take 0.25mg of Finasteride ONCE A WEEK and see how you tolerate it. If you feel OK after 3 months then it's all good Keep taking it ONCE A WEEK until we get our hands on one of these cutting edge treatments.

Since its early days for you... taking it ONCE A WEEK will really slow things down for you

Hope that's helpful

Thanks for the advice Desmond, really appreciate different point of views.

I might even be willing to go with 1 Mg per week... I mean I was taking the Propecia on a daily basis before... I will be fine with one whole pill once a week. I'd be willing to even go up to 1 pill every other day, sides were not so bad.

Thanks again

[yeahyeahyeah]

If this ends up being the case there will still be hl forums and depressed guys everywhere because modern ht density still looks very bad. if all we are hoping is that histogen and the others do is halt your hair loss at say nw 4 so you feel safe to use all your donor on an ht you will still look very very thin.

I thought we were being told that histogen was regrowing quite a bit of hair not just halting progression. so we've given up on them being able to cause regrowth of 40 hairs/cm2 ?

IMo the only way these treatments really become game changers is for people to be able to have ht and then histogen injections and add 40plus hairs per cm/2 on top of ht density. just my opinion.

It is regrowing hair; vellius hair.

[CAlex]

Look the reality is if you're above NW3 Histogen alone will not bring back your juvenile hairline...

Neither Histogen, Aderans nor Replicel will be able to do that...

These treatments will simply save the hair you have and cause a bit of regrowth...if you want a juvenile hairline, you will end up combining these cutting edge treatments with a transplant depending on how far your hair loss has progressed.

If this ends up being the case there will still be hl forums and depressed guys everywhere because modern ht density still looks very bad. if all we are hoping is that histogen and the others do is halt your hair loss at say nw 4 so you feel safe to use all your donor on an ht you will still look very very thin.

I thought we were being told that histogen was regrowing quite a bit of hair not just halting progression. so we've given up on them being able to cause regrowth of 40 hairs/cm2 ?

IMo the only way these treatments really become game changers is for people to be able to have ht and then histogen injections and add 40plus hairs per cm/2 on top of ht density. just my opinion.

[Desmond84]

So, if I heard you right, the approval process is separate in each country, but a company may have conducted trials in such a way to apply for approval simultaneously at all of them?

Yep, pretty much

Desmond, I was thinking FDA likes to sit on the data about six months after completion, not 10 to 15, but that was just my second hand opinion. I know you've written some of this before, but what exactly is the cadence in your mind for the next 2 years besides the 12 month trial part?

Does it take time to design/submit a phase 3 trial before you start?

Is it normal to spend time before getting approval on commercialization?

Thanks!

OK, so first thing that needs to happen is Phase 3 needs to end! Then it takes approx. 2 months to gather all data and analyse everything.

Next step is submitting a New Drug Application (NDA) to the FDA. This involves filling out a lot of submission forms followed by (literally) a truck load of data in sealed boxes.

Once you submit your NDA, the FDA on average takes around 10-15 months to process your application.

The 6 month thing that you mentioned is granted to life-saving medications only (i.e. cancer) through a Priority Approval System! Unfortunately Aderans wont qualify for that

FDA has actually published a graph of how long it took them to process application between 1988-2008. Check it out:

(Its the second graph on the page with the heading: Median Approval Times)

http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm209349.htm

So in short, from the time you complete your Phase 3, it will take another 12 months to get your product on the market!

[Desmond84]

What's your view on Dr Nigams clalims on HM?

I'll be honest with you BB, there's no way in hell I'd fly to India to undergo any operation!

He claims he has TWO things going:
1) Dr Gho's HST
2) Stem cell therapy

If I'm going to do get HST, I'd rather get it done in Amsterdam than Mumbai!

Regarding his Stem cell therapy, a lot of companies are/did conduct trials on it and failed to produce any hairs so I don't know how he does it! This is where the concept of published peer-reviewed journals comes from. Until he does that, no one should fly over there to get it done! Period.

You know, you hear time and time again how much the outcome of a hair transplant is dependent on the skills of the surgeon. So you should really be extremely cautious when it come to these clinics in third world countries!

[StinkySmurf]

So in short, just because you got your product approved by FDA doesn't mean you can role out your treatment in Europe, Japan or Australia.

So, if I heard you right, the approval process is separate in each country, but a company may have conducted trials in such a way to apply for approval simultaneously at all of them?

Desmond, I was thinking FDA likes to sit on the data about six months after completion, not 10 to 15, but that was just my second hand opinion. I know you've written some of this before, but what exactly is the cadence in your mind for the next 2 years besides the 12 month trial part?

Does it take time to design/submit a phase 3 trial before you start?

Is it normal to spend time before getting approval on commercialization?

Thanks!

[Breaking Bald]

Yeah dude if Lauster brings out Hair multiplication baldness is no longer a curse but a fashion statement LOL

But that's at least 7-8 years away (even longer to be honest)...

Lauster is where Aderans was back in 2002! So, in the mean time we really should root for these other treatments to save our hair at least for the next decade

What's your view on Dr Nigams clalims on HM?

[Desmond84]

not to change the subject of this thread..but what do you know about the hair multiplication? if that came out everything else would pretty much be useless right? that would be as good as a cure?

Yeah dude if Lauster brings out Hair multiplication baldness is no longer a curse but a fashion statement LOL

But that's at least 7-8 years away (even longer to be honest)...

Lauster is where Aderans was back in 2002! So, in the mean time we really should root for these other treatments to save our hair at least for the next decade

[Desmond84]

Hey Desmond,

Do you know what Aderans has going in Europe or say Australia?

Does FDA approval give you EU / UK / Australia / Japan approval or will Aderans be starting over with a multi year trials in EMEA?

Thanks!

Well I'm pretty sure they are planning on rolling out ji gami all over the world around the same time ie EU / UK / Japan / US / Australia.

I base this on the fact that they have been filing for patents in all these regions since 2002. Here's the link for their patent protection in Australia for example:

http://www.ipaustralia.com.au/applicant/aderans-research-institute-inc/patents/

With regards to the Approval process, every region has their own INDEPENDENT regulatory approval body and they're all pretty strict!

TGA (Australia)
EMEA (Europe)
PMDA (Japan)
FDA (Europe)

On average most of these organisations take 10-15 months to process an application once Phase 3 is completed!

Some regulatory bodies prefer specific types of trials,, e.g.
EMEA (Europe) prefers comparing new drug against the current gold standard (i.e. Propecia), whereas
FDA (US) prefers comparing new drug against placebo in Phase 3!

while others such as TGA tend to follow EMEA!

So what a lot of companies do is they have 3 treatment arms in their trials: one using placebo, one using Propecia and one using Ji gami for example. This will keep all regulatory bodies happy.

Some companies though opt out for FDA approval first (placebo-controlled) and hope for the best with other regulatory bodies!

So in short, just because you got your product approved by FDA doesn't mean you can role out your treatment in Europe, Japan or Australia.

South Korea, Singapore, Hong Kong and Taiwan are a different story though. Their regulatory bodies have just recently formed and they seem to be quite laxed regarding drug approvals!