What is "Proof of concept"?

[TravisB]

Can someone explain me in simple words?

Because I see at Cosmo Pipeline here - http://www.cosmopharmaceuticals.com/...line-04-13.pdf that they plan to finish Phase II proof of concept CB-03-01 study for alopecia by first half of 2015.

What does it mean? Is it legit Phase II trial? Will they be able to go to phase III afterwards and then release it to the market?

EDIT:

Ah, I found that it basically means Phase I/IIa. But what about Phase IIb? Will they still finish it by H1 2015?

[KO1]

"We will show you it works on humans and not mice"

[TravisB]

Actually they did proof of concept study in humans in 2010 (so it was phase I or something??) on group of 40 men and it worked very well - http://www.cosmopharmaceuticals.com/...010-10-06.aspx , they applied it using something called "iontophoresis" which is drug administration using electricity. I wonderif they will find the right vehicle to put it on market shelves some day?

What I mean is if we can understand this proof of concept trial as official FDA trial process?

[Thinning87]

I think they are based in Milan (right outside Milan, in fact less than 2 KM from where I grew up if I remember correctly from their slides) and if that is true they would most likely seek regulatory approval in the EU I would imagine.

[yan]

Actually they did proof of concept study in humans in 2010 (so it was phase I or something??) on group of 40 men and it worked very well - http://www.cosmopharmaceuticals.com/...010-10-06.aspx , they applied it using something called "iontophoresis" which is drug administration using electricity. I wonderif they will find the right vehicle to put it on market shelves some day?

What I mean is if we can understand this proof of concept trial as official FDA trial process?

Its for sure an official FDA trial process. If they want to adjust something (dosage etc.) or improve phase 2a results, they might start a phase 2b or skip it and jump straight to phase 3. Thats how I understand it...