Rivertown therapeuthics? Really? Source? Cause they patented a compound that is said to give insane regrowth. Didn't know follica was going to use that compound.
Puretech Health - 2017 Annual Report (2018-04-16)
- Thread starter Noisette
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What is meant by the word 'next-generation medicine'? is this medicine that Follica herself develops? (I think no). In patents they refer to seti, samumed, switch biotech (phase 0), etc. Follica with a wound and minoxidil will give you 10-15 hairs per centimeter, but they will state that with the drugs of the new generation the results will be better, but will have to wait.
The first release is probably just the device, which is subject to a different set of rules than drugs https://en.wikipedia.org/wiki/Medical_device
"The USFDA allows for two regulatory pathways that allow the marketing of medical devices. The first, and by far the most common is the so-called 510(k) process (named after the Food, Drug, and Cosmetic Act section that describes the process). A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls, as described below, are met. The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. The second regulatory pathway for new medical devices is the Premarket Approval process, described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway."
It seems like this dermarolling type device would probably be considered a Class II device:
"Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes"
So they are likely doing some safety trials and minor efficacy trials in order to get FDA clearance on the device with minoxidil. Then they will work on developing a new compound which should be more effective than minoxidil but this will require a new set of phase 1-3 trials and would be 5+ years away.
"The USFDA allows for two regulatory pathways that allow the marketing of medical devices. The first, and by far the most common is the so-called 510(k) process (named after the Food, Drug, and Cosmetic Act section that describes the process). A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls, as described below, are met. The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. The second regulatory pathway for new medical devices is the Premarket Approval process, described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway."
It seems like this dermarolling type device would probably be considered a Class II device:
"Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes"
So they are likely doing some safety trials and minor efficacy trials in order to get FDA clearance on the device with minoxidil. Then they will work on developing a new compound which should be more effective than minoxidil but this will require a new set of phase 1-3 trials and would be 5+ years away.
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Yes you are right, it's all true. But I doubt that they themselves will develop a new medicine, rather they will recommend funds developed by other companies, as I wrote above.
It has already been stated, as shared in one of the updates that Noisette shared months ago, that the phase 3 pivotal study is for the wounding device
They already know what they will be using initially
and the rest of us call it "You don't know what the hell you're on about" as usual. All of the hate you express toward this company is solely based on the fact that it's not who you want to "win".
This kind of thing is not uncommon. We know that they have tested various compounds over the years, and there are obviously a number of parameters to consider pertaining to the wounding. You absolutely want to make sure you have the best protocols to achieve optimal results, all across the board, for every patient, as you go into the last trial.
Next item: As Occulus has explained before and Swoop had posted way back, PureTech did their own market research and found that the main reason most people don't use finasteride or rogaine is not because "sides" or other sh*t, but because it doesn't provide satisfactory regrowth. Therefore, they know they will have to produce something better.
You really think these people, who already have an FDA-approved weightloss pill coming out in the next year or so, got to where they are by being f*****g idiots? You think they've poured 10s of millions into something that isn't going to give them serious returns?
Lastly, and best of all: The ship has already sailed that this will work to grow new hair, and quite substantial amounts of it in fact. There is plenty of science that proves it. sh*t, just recently there was a study that found it's even possible to grow hair in the scalp of an 80 year old man with wounding and no chemical assistance. Thus, it is obvious that with perfection of the technique, and stimulation with different compounds (some of which may yet be unknown to us), this is a perfectly viable method of growing new hair. It's also a fact that it can repeated.
Now, you can argue that maybe it won't be permanent, people will likely see a bit of variance in results, it may depend on age, it's a "bridge" technology, etc. and you may be right.
But take it from me, a guy who doubted this before bothering to read more up on it: Anyone who thinks that this tech isn't worthwhile, and our nearest solution, is talking out of their ***.
It astounds me how people here actively bet against their own best interests.
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ALL OF YOU don't understand nothing... @hanginginthewire @Hate da Bt @wc5269@RolandconilWhaaaaaaat???!! Noooooo!!!
Don’t these phases have to mean something? You make it sound like after Phase 3 is completed they will be pleased to announce they are entering Phase 4. And then 5. 6....
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I'll enjoy watching lord choi shutting these lameos down for good so much
admirable skills of inflating having done absolutely nothing in 10 years
admirable skills of inflating having done absolutely nothing in 10 years
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Excellent post.
So you're confirming what I said then... They don't have a novel compound to go along with this device anywhere close to market (or at least we have no proof of that). I never said the device was 5 years away. I was responding to someone asking if it was just the wounding device coming out initially.
Dumb logic to use with a pharmaceutical companies product considering only 60% of phase 3 trials succeed. Those 40% that failed all have 10s of millions (hundreds for most) invested in them. It's called a calculated risk. That's why they're not idiots even though there is still a chance this fails.
I agree that the science and clinical evidence behind wounding is strong.
they've stated that they've conducted 3 clinical trials, only one was wounding alone? their protocol also involves a visit to a dermatologist, so i doubt they're just gonna bring just the device and nothing else.
"If we knew what it was we were doing, it would not be called research, would it?"
-albert Einstein-
Yeah but the "drug combination" that they are testing it with could just be min or some other known growth stimulant. At least that's how I'm reading this press release and what is on their site. I think they would make it very clear if they had their own compound that they were doing these trials with, especially given it is a publicly traded company.
Their patent list is so long and their procedure so secretive, i dont think you can conclude anything meaningful tbh.
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So... 10 more years
What the hell are you talking about ? what studies concluded that wounding and neogenisis can regrow substantial amount of hairs ? the guy who's 80 years old you're talking about suffered from scalp burn and they saw that he regrow 2 hairs afterwards ? you think that the treatment is legit just because they're pouring millions into it ? lol welcome to business and marketing. we can sell f*****g rocks in a box and make millions out of it and i'm not even kidding search that.
After the many deceptions, and the recent one from brotzu i'm not hypping on anything unless i see miraculous results in front of my eyes not just theoretical numbers on studies
Exactly,that's what makes this forum so biased, you have to keep that in mind my friend
Well, I'd say that given their previously stated timeline and the fact that they are in the pre-pivotal as planned, I'd say that sometime next year is most likely.
That is of course assuming they start the full-on, Phase III pivotal within the next couple months. They said they planned to initiate that in the first half of 2018, and a couple months away from that deadline.
All the ones you can easily find discussed for the last five or more years on this site. By the way, the doctor with the most famous and successful study regarding the issue recently became a board member of Follica.
Also regarding minoxidil that you or someone was complaining about earlier. Yeah, minoxidil likely will be one of their compounds. But again, this has been successful in the neogenesis studies and you are literally complaining about them using the only drug presently on the market that CAN grow hair!
Yes, welcome to business and marketing.
Rocks put in a tiny box cost absolutely nothing to research and manufacture. Same with "essential" oils or Chinese laser helmets.
But pouring tens of millions in research and development, and going through the FDA processes into something that doesn't do anything does not happen. Maybe in Mexico (Histogen) or the Bahamas, but in the United States and Canada who actually have rigorous protocols involving these kinds of things.