I agree with some of what you said there, but ive been doing a lot of reading about clinical trials recently to try and gain a better understanding of what they may need to do.
Its highly unlikely that they will be able to miss out phase I altogether, however it will be much faster as the data from the drugs previous aproval is taken into account, but not soley based on this.
While they have done the bulk of the pre clinical work with cotsarelis mouse studies, the current research study is described by Zohar as an investigator-sponsored trial, which is part of the IND process. Which would sudgest that they haven’t yet been designated IND status.
Which would leave them unable to test their drugs untill they do so, however no human data is needed for an IND, so they have already applied using pre-clinical data or are close.
I disagree with you when you say it will fall into a grey are because they are marketing a procedure and not drugs, I wont go into too much detail but a drug is a drug regardless of whether it is part of a procedure or not, they will also have to show the safety of the drugs in combination.
It is already pretty much comfirmed that they will need an NDA (Which is FDA approval).
What they haven’t told us is how long exactly they intend to spend on each phase.
Your right though, we need to stop speculating and wait for follica to tell us, as nobody can be certain untill then.
They seem pretty confident that they will have a viable product, and want to sell it to us asap.
Zohar says data from the current trial wont be in for at least a year, so I guess we will know more then.
Just for reference, here’s pretty much the only information we have regarding time lines;
http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
“Folica, which licensed the technology from the University of Pennsylvania school of medecine, will begin human trials this year. If the results are positive, the company could be positioned to file for an Investigational New Drug Application in two or three years, Zohar says”
“Right now their money is funding a small human study which Zohar describes as “more of an investigator-sponsored trial.” And the company has enough money to push the program through proof-of-concept toward an NDA - a path that’s likely to take an accelerated development path that compresses the usual early and mid-stage trials into a 24- to 36-month window. An approval could conceivably be won in four to five years.
“What’s nice about it,” she adds, “is that even though this is based on breakthrough science, we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people.”"
With the regulatory path relatively clear, Follica’s plan was to use its Series A money to quickly begin a small proof of concept study, involving 15 to 20 patients. Zohar yesterday confirmed that a pilot study is underway but wouldn’t confirm where or give any other details on its timing other than to tacitly stick to the timeline she laid out in January, when she said that final data from the study would not be available for at least a year. “Everything is progressing on track,” she now says. “We are moving as quickly as possible within the constraints of clinically driven medicine.”
“A proof of concept study involving 15 to 20 patients (Follica has no shortage of volunteers, as several hundred people sent in e-mails when word of Cotsarelis’s work reached the public) should begin in the next few months. The trial has several phases, however, and Zohar cautions that final data won’t be in for at least a year.”
“This financing will enable us to build out the company and move well down the path towards [regulatory] approval,” says Daphne Zohar, managing director of PureTech Ventures (and an Xconomist)."
Dr George Cotsarelis - MSNBC Video
“If everything goes perfectly, it’s possible that within a few years we’ll have something that is available as a new treatment.”
Nancy Snyderman - MSNBC Video
“We are going to have to see human trials which will be in the next year or 2. And I wouldn’t be surprised if this uh, didn’t turn out to be on the market in the next 3-4 years, maybe even sooner.”
