Aderans

[Joker]

Whoah.

Bummer about that 2016/17 thing... but perhaps they'll offer it in another country first?

Still, whoah.

[hellouser]

Whoah.

Bummer about that 2016/17 thing... but perhaps they'll offer it in another country first?

Still, whoah.

I'm going to call the FDA and try and get some answers from them about this. I wouldnt take it all too seriously until theres some final concrete answers in regards to the 'commercial product' date.

In my eyes, if *three* clinical trials are done and all come back without any complications, I really don't understand why the FDA would require up to three MORE years (basically double, one year for each phase) of study? It doesn't make sense to me, I thought the whole point of the clinical trials was specifically FOR safety and all that, especially Phase I (Replicel stressed the safety requirement and results of phase I).

I'm really confused....

[Joker]

Never underestimate the corruption of American bureaucratic agencies.

Still, let's focus on the good news! Maybe the FDA will cut us baldies a break for once!

[krewel]

Whoah.

Bummer about that 2016/17 thing... but perhaps they'll offer it in another country first?

Still, whoah.

Very likely, yes. Aderans is a Japanese company. The FDA is not really relevant in Japan. Europe is possible too.


hellouser, thank you very much! Great news! ... You could upload that file to Zippyshare.

[hellouser]

Never underestimate the corruption of American bureaucratic agencies.

Still, let's focus on the good news! Maybe the FDA will cut us baldies a break for once!

Check this link:

http://www.fiercebiotech.com/topics/fda_approval_process.asp

Phase III

Phase III is a large-scale study of the effectiveness and side effects of the drug in a larger population, usually ranging from 1000-3000 patients. If the drug is submitted to the FDA for approval, the FDA will look at the Phase III data to determine if the drug is safe and effective. Aside from testing the drug’s viability, the company producing the drug also determines the logistics involved in creating a large supply of the treatment. Phase III of the FDA approval process takes about three years.

I think if anyone wants a faster approval, you guys, Americans... will need to do some heavy protesting. I've done it before in Canada, and if people come out in large enough numbers, you CAN get what you want and what you deserve. At that point, I can only count on PROACTIVE americans. Being in Canada for the past 22 years, ive realized that Canadians are the most passive individuals on the planet with zero backbone... protests here are a joke, I hope this isnt the case with you guys.

Bah....

Although, this does raise an interesting point.... can other nations give the go ahead for a commercial product going by american clinical trials alone?

[krewel]

Although, this does raise an interesting point.... can other nations give the go ahead for a commercial product going by american clinical trials alone?

Yes, they can. But in Europe it's probably even more difficult to release them that fast. It's different from country to country. For example in Germany, the foam version of Minoxidil got approved this month.

But in an Asian country like Japan, it's way easier to release treatments and they probably will release Ji-Gami there at first, since Aderans is a Japanese company.

[hellouser]

Yes, they can. But in Europe it's probably even more difficult to release them that fast. It's different from country to country. For example in Germany, the foam version of Minoxidil got approved this month.

But in an Asian country like Japan, it's way easier to release treatments and they probably will release Ji-Gami there at first, since Aderans is a Japanese company.

Thats germany alone though, some european countries have more lax laws on things like this. But thats just europe, if Japan is a candidate for a quick release of the product, you can be sure i'll have a booked flight... thank god i have friends there

[Alf]

But in an Asian country like Japan, it's way easier to release treatments and they probably will release Ji-Gami there at first, since Aderans is a Japanese company.

Are you sure it is easier in Japan?

[Alf]

The bad news is this, and I really hope that this isnt the case... After the clinical trials are up, the FDA requires 2-3 years of more results/testing before giving the go ahead and having a final product on store shelvesaderans gives us their update.

Fu*k, but if that is the case why wouldn't they show it in the 2010 presentation:

http://img545.imageshack.us/img545/4181/aderanstimeline.jpg

Not saying I don't believe the girl on the phone,I do, but how can they not include it in the presentation?

[hellouser]

Fu*k, but if that is the case why wouldn't they show it in the 2010 presentation:

http://img545.imageshack.us/img545/4181/aderanstimeline.jpg

Not saying I don't believe the girl on the phone,I do, but how can they not include it in the presentation?

We'll soon find out. Regardless, balding americans need to make a stand....

I'm gonna call the FDA and see what they say. I guess for the time being we have to hope aderans gives us treatments in 2014... if not im gonna see if Gho is a viable option with a future treatment from aderans (or other).

[Alf]

We'll soon find out. Regardless, balding americans need to make a stand....

I'm gonna call the FDA and see what they say. I guess for the time being we have to hope aderans gives us treatments in 2014... if not im gonna see if Gho is a viable option with a future treatment from aderans (or other).

Would be strange if FDA said, **** safety this is a cure for baldness:-) Or that 1000 people outside FDA HQ could make a difference. Can't blame them, but as I said stange that Aderans didn't account for this in 2010.

And if Aderans is only injectioning my own hair cells, it seems completely safe.

[gmonasco]

The bad news is this, and I really hope that this isnt the case... After the clinical trials are up, the FDA requires 2-3 years of more results/testing before giving the go ahead and having a final product on store shelves.

I don't know of any additional testing requirements after the initial clinical trials have been completed and the New Drug Application has been submitted to the FDA. The FDA may sometimes specify phase IV trials as a condition of approval, but those trials take place after drugs have been approved for sale.

[hellouser]

Would be strange if FDA said, **** safety this is a cure for baldness:-) Or that 1000 people outside FDA HQ could make a difference. Can't blame them, but as I said stange that Aderans didn't account for this in 2010.

And if Aderans is only injectioning my own hair cells, it seems completely safe.

It pretty much is, its kind of like asking 'can I infect myself?' The obvious answer is no.

[hellouser]

I don't know of any additional testing requirements after the initial clinical trials have been completed and the New Drug Application has been submitted to the FDA. The FDA may sometimes specify phase IV trials as a condition of approval, but those trials take place after drugs have been approved for sale.

Maybe it depends on the type of drug/procedure in terms of years or any waiting time at all? Would it be fair to assume that there are different timelines for different applications especially with three phases of clinical trials?

[JJJJrS]

Christ, I just checked the call recording quality and it is absolute CRAP. I can barely hear the girl that was on the phone with me, the quality is so bad its pretty much inaudible. I should mention I was at a restaurant with a lot of ambient noise.... I'll make another call to another location from home where its quiet, I should get a better recording (I'm really pissed).

In short, YES, they are taking in participants for Phase III as their Phase II trials have ended. Each location is in different phases, but again according to the clinical trials page online, all of them are in AT LEAST in the end of phase II. She also mentioned that Phase III will probably take around a year so the 2014 projected date they set in 2010 seems legit.

The bad news is this, and I really hope that this isnt the case... After the clinical trials are up, the FDA requires 2-3 years of more results/testing before giving the go ahead and having a final product on store shelves. So 2016/17 at this point seems more likely the case, BUT that also means that the presentation given in 2010 is also wrong since it *clearly* showed a commercial product in early 2014, which means a product for the public.

The great news is this:
They are only injecting a few hundred cells and their results are great, she mentioned the patients are walking out with THICK terminal hair so their solution is working. Of course, this was only a few hundred injections which means we could expect more hair or better results with more injections. I asked about the temple areas and she couldnt give a response since they are only focusing on the crown area. I wonder though, if the hairline/temples would require additional information or longer wait periods for the FDA to give clearance on their procedure.

I can put up the recorded conversation if someone knows a site where I can upload and share a 15mb file, but its really moot as the quality is absolutely awful (you can hear me just fine, but not the woman on the other end is very faint). I'm really pissed because she had a lot of great answers for me and its a 10 minute conversation, plus she mentioned shes with the company for 5 years.

Regardless, we're going to have much better information by january when aderans gives us their update.

Thanks for taking the effort to call them. Too bad the recording didn't seem to work out but there's still plenty of interesting info in your post.