New Puretech Website Layout (pivotal Trial First Half Of 2018)

[Xaser94]

http://puretechhealth.com/index.php?option=com_quix&view=page&id=17&Itemid=158

 

[H]

"~3-4× of currently available drug therapies" while its not game changer not going to fill in bald areas temples vertex and such by any means for slightly diffused this could get them right back to almost full density good stuff.

 

[Xaser94]

"~3-4× of currently available drug therapies" while its not game changer not going to fill in bald areas temples vertex and such by any means for slightly diffused this could get them right back to almost full density good stuff.

Unless results are compoundable, and you can keep going back. Dont know if thats how it would work, but it is possible.

 

[Dantes']

Huh so it appears it still states they are going to start during 1st half 2018 for the pivotal trial. Under milestones however it seems that the pilot optimization study will start in early 2018 with the actual pivotal trial starting 2nd half of 2018. Not cool haha.

 

[Rolandconil]

will be released in 2020
15 f*****g years

 

[Dantes']

I know it's just possibly only a 6 month delay from the last delay but this is getting annoying lol.

 

[MomoGee]

will be released in 2020
15 f*****g years

The classic case of being 5 years away every year.

 

[dermrafok]

DR. KEN WASHENIK. Can we trust in him? And in Follica?

 

[mdmnota]

Hahahahaha, bring that guy back in the light of recent news

 

[H]

Unless results are compoundable, and you can keep going back. Dont know if thats how it would work, but it is possible.

That would be awesome if it did but in my opinion this is based on dermarolling + minoxidil and people have been doing multiple wounding sessions with no significant compounding effects even the dhurat study had multiple wounding sessions. I personally believe it will have results similar to a lesser quality small hair transplant but I'd love to be wrong.

 

[Breyfogle]

Hmmm. I typically only understand clinical pipelines in terms of Phase I, II, and III. Safety, efficacy and whatever.
What are "pivotal" and "optimization" trial and how long do they usually last?

 

[br1]

A pivotal is a Phase III. So after that they can go to Market.

How long does it usually takes???

 

[hellouser]

will be released in 2020
15 f*****g years

View attachment 64104

Psychotic regulations really need to stop. You don't come to the conclusion a treatment/drug is unsafe without testing on humans. FDA badly needs a reform, it's absolutely disgusting seeing the wait times for medical advancement.

 

[hellouser]

"~3-4× of currently available drug therapies" while its not game changer not going to fill in bald areas temples vertex and such by any means for slightly diffused this could get them right back to almost full density good stuff.

Thing is, why are they using the term 'neogenesis' when it implies NEW follicle creation? If that's the case, it shouldn't matter if it's vertex, crown, temples, diffuse, etc.

 

[Dantes']

Thing is, why are they using the term 'neogenesis' when it implies NEW follicle creation? If that's the case, it shouldn't matter if it's vertex, crown, temples, diffuse, etc.

Yeah that is the one thing I never got if it is neogenesis wouldn't they be able to create essentially as many follicles as they want, or am I missing something.

 

[Ikkaku]

I'll be Bald lmao

 

[dermrafok]

A pivotal is a Phase III. So after that they can go to Market.

How long does it usually takes???

https://en.wikipedia.org/wiki/Pivotal_trial Yes Pivotal trial is a "Phase III".

 

[Dantes']

A pivotal is a Phase III. So after that they can go to Market.

How long does it usually takes???

Well I remember from one of noisettes posts that had a chart for puretechs pipeline that when they had originally anticipated starting follicas trials in Q1 2017 they listed possibly regulatory clearance for Q4 2017. If that holds true now then basically within a year.

 

[malnuhair]

This could be a stupid question but I know literally nothing about the clinical trial process. I know Follica is out of Boston, does that mean the trial will take place in the Boston area? I live 5 miles outside the city and would love to try and get in on this.

Also, the whole "neogenesis" thing is what has me pretty excited for this tech. If we take them at their word, then it seems like a technology that could potentially get much better. In my most optimistic coping feelings I would like to believe this is why it has taken Follica so long, they want to release the absolute best product they can.

 

[br1]

https://en.wikipedia.org/wiki/Pivotal_trial Yes Pivotal trial is a "Phase III".

I know that. What I wrote was an affirmation.

How long, though, was the question.