We don’t want the FDA eliminated. :no:
Improved? Yeah. But not eliminated.
[quote][postedby]Originally Posted by Lucky[/postedby]
Assuming they have the funding they need, are we talking about 3 years, 5 or 10 ? Is it worth waiting for or should I get a hair transplant first? Nothing would make me happier than to be able to get off the meds.
[postedby]Originally Posted by Mr. Z[/postedby]
We can’t make that assumption “they have the funding they need”. Because they don’t. They said in the article they’re looking for partners.
Also, they’ve only demonstrated hair growth in immunodeficient mice. If you recall, Replicel managed the same thing. So, even though it looks promising, it’s not a solution that’s guaranteed.
Lastly, there is still much work to be done from a basic research perspective. Will it work in the tortured environment that is the male balding scalp? Hair cycling and control of growth direction etc… not to mention safety issues, will all need to be worked out. This will take time. Then you can tack on the obligatory 5-10 years for clinical trials. Though, I’ve never seen a trials completed in 5 years.
As you can see with Replicel’s current upcoming trial, due to the nature of hair growth/cycling, it takes a long time to see final results. They need to demonstrate, not only that they can grow hair, but that the hairs stay put and don’t degrade, that they’ll grow as a normal hair does.
Unfortunately, that takes a long time. So phase II alone will take a few years to conduct.
Couple more years for basic research + partnering/funding time + time for organizing clinical trial and recruiting trialists + 5-10 years of trials (5 if asia route estimate) = long time
In other words, this is not coming to a theater near you anytime soon. If they conduct this in Asia, then it may be a bit quicker. But, it will still take a long time.[/quote]
In just one week, we go from really excited and optimistic to it’s not coming anytime soon.
Studies prove the FDA kills more people than they save. I had a client who had cystic fibrous. Before he died, a very promising drug was in stage 2 clinical trials but he could not get access to the drug. Researchers had already determined the safety of the drug. That drug is available now 6 years after his death! Life changing for those who are taking the medicine. He should of been given an option to take a chance on living. If we must have the FDA, their only responsibility and concern should be safety. Concerning this latest discovery, several companies have advanced to stage 3 clinical trials with similar studies so why should this procedure be required to start at stage 1?
[quote][postedby]Originally Posted by Lucky[/postedby]
In just one week, we go from really excited and optimistic to it’s not coming anytime soon.[/quote]
Not sure who “we” are - but, anyone who’s at all familiar with what it takes to
bring a new treatment to commercial fruition would know that something in the basic
research stage is a very long way off. Easily 10+ years. If you’re young i.e. under 20, then you may
reap the benefits of these findings some day, when and if they come to market. For those
of us who’ve been around here longer - this is not likely to be available in timeframe
that is commensurate with our needs.
It pretty much comes down to Replicel and Histogen as the only treatments on the Horizon for the next 5-10
years or so. We may see something like CB make it, but, we already know the effectiveness of the DHT
approach; which is to say minimal at best. So cross your fingers and hope that Replicel knocks their
phase II study out of the park. We should have results from that 206-2017 timeframe.
Anyone know what the hell Histogen is up to? I’ve seen molasses move faster in subzero temps.
Who is CB?
intercytex tried doing it and gave up, aderans tried it and also bought the assets of intercytex and failed. This new research group is looking for partners… i wonder if aderans would reach out to them because unlike replicel or histogen, the dermal papillia was their route in search of a solution.
In three years time we should have two options from replicel and histogen, even when it’s released in Asia first.
We can be thankful that rep and his are taking advantage of japans new laws for regenerative medicine.
Come on companies get your phase 2 and 3 trials rolling!
I thought of that too, Macgyver. Aderans/Bosley/Hair Club would sort of be a natural partner in a number of ways, if they could structure an agreement where everyone gets paid. Aderans could provide their experience, international contacts and the Hair Club network a source of prospective patients, and Bosley as a potential base from which to offer the procedure, employing their doctors, of course. (Remember Aderans owns both Bosley Medical and Hair Club now).
On the other hand, the perception might be that Aderans’ failure was so huge, that they botched things up somehow and they would offer nothing but a grindingly slow approach to clinical trials and bad luck.
[quote]
[postedby]Originally Posted by Mr. Z[/postedby]
It pretty much comes down to Replicel and Histogen as the only treatments on the Horizon for the next 5-10 years or so. We may see something like CB make it, but, we already know the effectiveness of the DHT approach; which is to say minimal at best. So cross your fingers and hope that Replicel knocks their
phase II study out of the park. We should have results from that 206-2017 timeframe.
[postedby]Originally Posted by chris[/postedby]
Who is CB?[/quote]
http://www.cosmopharmaceuticals.com/activities/pipeline/cb.aspx