Depressing.It may very well work. I sure hope it does, but we're years away from seeing this come to market. A new study is starting at the end of the year.
Press Release: Follica Announces Progression To Pivotal Study Following Positive Interim Data In Ma
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MrJolly16
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It may very well work. I sure hope it does, but we're years away from seeing this come to market. A new study is starting at the end of the year.
I highly doubt that, given that they're using FDA-approved chemicals in the first run of the treatment.
Well, if the study doesn't begin until Q4'19, one can assume that - under the best of circumstances - it ends in Q4'20, followed by another 6-12 months of data analysis, followed by submission to FDA for approval. Assuming all goes well, I can't see it commercially available - i.e., you can walk into a derm's office and get the therapy - until second half of '22 at the earliest. If there are bumps along the way, sometime in 2024. And I'm not a Follica cynic - I am certain their protocol works, that it grows a lot of hair, and that it will be available, I just think that, if we're still in the trial phase, it's going to be several years before you can actually get your hands on it, even if they only initially launch with minoxidil.
Sure, but given that the optimization study took like 6 months, I doubt that the pivotal will take much longer. This isn't rocket science, they go over your head with it, you follow the protocol, results start at 3 months. I'd imagine they'll be following up with people from the optimization as well. Yeah, true they have to submit stuff and wait, manufacture, etc. but the only thing they're seeking approval on is the device.
If they get approval, and have enough supplies to ship, I don't see why they couldn't begin treating people even just from their own clinic right after they get approved.
Also to add on top of that. There are exceptions for each trial. Considering they are using already approved drugs in the phase 3 trial and the device’s background has a lot of information about wounding I don’t see how they would need even 6 months to see the benefits. Data analysis will also not take long if the trial is small and the trial is shorter.
I hope you're right, I just don't see how a company could go from commencement of trial to commercialization (as in, you can walk into the office and get it done) in under two years. I mean, they still have to ramp up production, which is not something they would do until they are absolutely certain it is approved (unlike other aspects of it that they could pursue while the FDA does its final review - marketing, identifying and selling to suitable derm practices, etc.). My best guess is somewhere between two and three years from the beginning of the pivotal study, and certainly less than four. But as I've said before, this IS coming to market, and it DOES work; for us lower NWs (<NW3), it's a game-changer, and once they clear their novel molecules and add them to the protocol, it might be full heads for everyone. I've been following Follica for a decade, and it's finally coming true.
I'll note that Puretech has enhanced their equity stake in Follica, and now controls 70%+ of the company - that right there says more about this protocol's efficacy than any study we've seen so far. And then there are all the other things in the pipeline - if there's ever been a good time for the bad fortune of losing your hair, it's now. Young readers, get on finasteride, minoxidil, and ketoconazole now - your dick isn't going to fall off, and it's going to significantly slow your loss until these new regiments become available. I started losing my hair 20 years ago, and I still have what looks like a full head of hair (albeit only with short hair styles) because of the Big Three, and Follica is going to let me regrow a nice percentage of what I've lost.
MrJolly16
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Take a look at the fourth or fifth photo... https://www.instagram.com/stories/drbhanusali/
As long as it's something that can regrow most of the hairline without a phony look, that's all I really need and it sounds like this should be able to do that so...yeah.
and yes, all the n00bz need finasteride; the fear-mongering is hilarious. Not to say side effects aren't real, but the bullshit on these forums is off the charts.
And there are many on here that would gladly participate in their trial and who are qualifying candidates.
Is this a joke? There are 3 photos.
Follica’s board really needs to get the ball rolling better and approve and publicly release either some photographic results of their trials or release more information on their device, press release isn’t really cutting it these days, they don’t exude “excitement”, people will loose interest and move on to other feasible alternatives (hair transplants now that they can be had much more affordably everyone and their brother is considering or getting one, Big 3, Microneedling, Breezula, realistic hair pieces, shave head and move on).
You don’t build excitement with years of silence then just offer up a press release about more trials to gain perspective customers. I would love nothing more than to see their method producing good to great results but share visuals, throw us some meat before interest fizzles off, follica folks!
You don’t build excitement with years of silence then just offer up a press release about more trials to gain perspective customers. I would love nothing more than to see their method producing good to great results but share visuals, throw us some meat before interest fizzles off, follica folks!
Cots has always been guilty of this. He wants to stay on the radar but that's it. He gets paid big money to keep researching. He wont put a thing out until he feels it will be a game changer. When that happens????
Sounds like it, but at some point his investment funds will dry up and investors will cut their losses and go elsewhere if they’re not getting a return on their investment, 20-years of R&D is more like 100-years in today’s rapid-tech-paced climate, and with no publicly released photographic results to show in a decade just seems like foot dragging.
What’s the point in having an “exclusive” patented agreement/device/growth compound if guys just move on to FUE hair transplants or microneedling or Breezula(when released). Loss of momentum is the enemy of business success.
And yet PureTech has INCREASED their equity in Follica this year. Weird thing to do for a failed product, huh Professor MBA?
It seems like you are not very litterate, where in my comment did I ever suggest they had a “failed product”?
Increased investment does not equate to product success or great results, there may be other reasons like running out of funds to continue their trials or more product development , my point is for them to release something visually showing some results as more and more people are loosing interest and going the cheap Hair transplant in Turkey or Dermarolling route with good results and not wanting to wait years if the company is so secretive with their trial results on an already public method.
thomps1523
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I think he’ll find it much more difficult to cultivate respect when he’s making comments like that... What exactly have we heard from tsuji in the last two years? This is how development of treatments works unfortunately.
I do find it ironic how much we esteem a position, and essentially assume they must understand all aspects of what another doctor does relative to his field... Your dermatologist likely doesn’t work with patenting, NDA’s within a company, etc. I have a son with hemophilia that almost bled to death on a hospital bed, because the doctor assumed it would stop, and forgot to check in. Some doctors need to stay in their lane unfortunately, but sometimes they can’t help but take advantage of the excess clout we give them.
Bottom line nobody knows what they have! All we can do is read the signs in the evolution of the company on the business side. That gives us the best hint at what they’re selling investors, and if they’re biting on it.
I respect your opinion but the Dr. Does have a point. Cots never has amounted to anything after these years. No picks no nothing.