Dr. Wesley has begun his 3rd 'Pilofocus' Phase Testing- I was finally involved!

[long4hair]

Regarding FDA trials for new tools and procedures.

http://ask.metafilter.com/237620/How-are-new-surgical-procedures-and-tools-evaluated

1. In the above linked information here is a key quote regarding new surgical tools:


"Compared to drugs, however, devices generally have much, much smaller sample sizes because the target patient population is usually not as large, and gathering more patients is not realistic."

2. In the above linked information here is a key quote about new procedures:

"As far as surgical procedures go, FDA wipes it's hands clean and considers these procedures "practice of medicine." This is a good thing as far as I'm concerned, because oftentimes doctors and surgeons don't have to be worried about liability when they're doing something for a patient that they consider to be best practice."


I'm not sure if the above information comes from people who know what they're talking about or if it's just postings by some JowBlows. The information in the above link could be accurate but I'm not sure about that.

[long4hair]

Thats the whole point. We dont know when or if it will be available.

Wikipedia is not a good source in this matter because it says that treatments have to go through two phase 3 studies and that's bs. Hair loss treatments have not been going through two phase 3 studies. They've been going through one phase 3 study. That aside, perhaps largestudies with many people are only required in the case of pills or elixirs because it would not be as expensive to have large phase 3 studies for pills and elixirs. But in the case of procedures the FDA might require smaller studies because procedures can be very expensive.

I do not trust Wikipedia in this matter.

[tedwuji]

So if all goes well when should it hit the market?

Thats the whole point. We dont know when or if it will be available.

[tedwuji]

Ah, yes, he's calling that '3rd phase' testing, but according to wiki's page on clinical trials (https://en.wikipedia.org/wiki/Phases...arch#Phase_III) an official 'phase 3' clinical trial sounds like a much larger and more expensive thing than what Wesley is doing. I'm under the impression it's so far just been him tinkering with this device on his own and out of his own pocket. I don't know if something like pilofocus has to go through the standard 3 trial phases before approval for the public though.

Probably true.

[allTheGoodNamesAreTaken]

Allthegoodnamesaretaken,Here below is a post by Artista that repeatedly states that Pilofocus is in phase 3.


Dr. Wesley has begun his 3rd 'Pilofocus' Phase Testing- I was finally involved!
Hello everyone!!

My wife and I returned home yesterday from Dr. Wesley's medical clinic.
I was a patient in his 3rd Pilofocus Phase Testing which took a few hours to complete on 11/12/15 and then we had a followup the next morning.
(his second phase testing (with just a few patients) was more or less because he had to once again update his very important endoscopic tools and instrumentation)
That was important.

Now he is onto his 3rd phase testing and Im excited to have been one of his patients. finally.
It did not bother me to wait this long.
I understood what was needed before he could continue.
I will add more to this later today,,it is every morning here in Illinois. I wanted to finally let all know about this.
Im hoping for the best for ALL OF US. So is Dr. Wesley!!

Ah, yes, he's calling that '3rd phase' testing, but according to wiki's page on clinical trials (https://en.wikipedia.org/wiki/Phases...arch#Phase_III) an official 'phase 3' clinical trial sounds like a much larger and more expensive thing than what Wesley is doing. I'm under the impression it's so far just been him tinkering with this device on his own and out of his own pocket. I don't know if something like pilofocus has to go through the standard 3 trial phases before approval for the public though.

[Breaking Bald]

Over halfway through Jan and no word, so tired of all the promises and lack of information and responses.

[long4hair]

Yeah it has been known for some time now that it is phase 3.

So if all goes well when should it hit the market?

[tedwuji]

Allthegoodnamesaretaken,Here below is a post by Artista that repeatedly states that Pilofocus is in phase 3.


Dr. Wesley has begun his 3rd 'Pilofocus' Phase Testing- I was finally involved!
Hello everyone!!

My wife and I returned home yesterday from Dr. Wesley's medical clinic.
I was a patient in his 3rd Pilofocus Phase Testing which took a few hours to complete on 11/12/15 and then we had a followup the next morning.
(his second phase testing (with just a few patients) was more or less because he had to once again update his very important endoscopic tools and instrumentation)
That was important.

Now he is onto his 3rd phase testing and Im excited to have been one of his patients. finally.
It did not bother me to wait this long.
I understood what was needed before he could continue.
I will add more to this later today,,it is every morning here in Illinois. I wanted to finally let all know about this.
Im hoping for the best for ALL OF US. So is Dr. Wesley!!

Yeah it has been known for some time now that it is phase 3.

[long4hair]

Nah, pilofocus isn't phase 3 yet. It certainly won't be approved this year if it has to go through 3 trials like drugs do. It'll probably be out before that ****ing liar 'Artista' comes back with more of his bull**** though.

Allthegoodnamesaretaken,Here below is a post by Artista that repeatedly states that Pilofocus is in phase 3.


Dr. Wesley has begun his 3rd 'Pilofocus' Phase Testing- I was finally involved!
Hello everyone!!

My wife and I returned home yesterday from Dr. Wesley's medical clinic.
I was a patient in his 3rd Pilofocus Phase Testing which took a few hours to complete on 11/12/15 and then we had a followup the next morning.
(his second phase testing (with just a few patients) was more or less because he had to once again update his very important endoscopic tools and instrumentation)
That was important.

Now he is onto his 3rd phase testing and Im excited to have been one of his patients. finally.
It did not bother me to wait this long.
I understood what was needed before he could continue.
I will add more to this later today,,it is every morning here in Illinois. I wanted to finally let all know about this.
Im hoping for the best for ALL OF US. So is Dr. Wesley!!

[allTheGoodNamesAreTaken]

In medicines there are 3 phases but I don't know about procedures. Is Pilofocus in the final phase and should the data be sent to the FDA for review and possible approval this year? Or is phase 3 with Pilofocus going to be more years?

Nah, pilofocus isn't phase 3 yet. It certainly won't be approved this year if it has to go through 3 trials like drugs do. It'll probably be out before that ****ing liar 'Artista' comes back with more of his bull**** though.

[tedwuji]

January

Coming and going...

[long4hair]

If Pilofocus is in phase 3 does that mean that trials are almost done?

In medicines there are 3 phases but I don't know about procedures. Is Pilofocus in the final phase and should the data be sent to the FDA for review and possible approval this year? Or is phase 3 with Pilofocus going to be more years?

If Pilofocus achieves quality donor regeneration but Wesley is still going to do more years of testing then Wesley's making a mistake because if Pilofocus achieves quality donor regeneration and Wesley can get it to market quickly he could own the market for awhile since Tsuji is going to be in the pipeline awhile. If Dr. Wesley can get a foothold in the market while Tsuji is still in the pipeline then Pilfocus could dominate the market long term because if Pilofocus builds a good reputation for achieving quality donor regeneration it could build a big following of customers. After all, why fly to Asia for Tsuji's hair germ implants if you can stay in USA and have unlimited donor supply (Pilofocus) right here in America?

[enterprise951]

I send a mail to dr wesley s office asking for the status of the pilofocus procedure, they answered me this:
"We are doing small sessions of pilofocus- a total of 400-500 grafts of which under 50 are done via the pilfocus method. This is still part of the study.
I hope this answers your questions"

[bornthisway]

.

No amount of thread bumping is going to provide new information. Even if Artista experienced regeneration there's no guarantee he can share that with us if there is a NDA. Wesley's rep in his year in review thread didn't even mention pilofocus which is not very encouraging. Pilofocus seems cumbersome and potentially more traumatic. If it does work I suspect it's a few years out.

[tedwuji]

January goooooing.