Puretech Health - Half Year Report - 08/30/2017

[nameless]

Noisette, since they're now testing their expansion protocol on human cells is there any possibility that things could go extraordinarily well with this present testing and the testing could wrap up substantially sooner than anticipated? And if that's possible could that speed up the time to get the treatment to market?

 

[Noisette]

I presume that Doctor Tsuji said Clinical application for clinical study in Japan.

So then they solved the expansion problem but so far not in humans and they're testing it in humans now, correct?

Not sure... That's why it's important to have Hellouser in Japan. He can interview Doctor Tsuji

If the pivotal trial starts in June 2018 then it's highly unlikely Follica could come to market before mid-2019. A pivotal trial could take 6 months or a year and then it takes a month or a few months to organize and submit all data to the FDA. And then it can take 6 months to a year for FDA to give it's approval. That could put marketing out as far as 2020.

And there's also the high likelihood that there will be another Follica delay and the pivotal study will start later than June 2018.

Follica has delayed just one study, one of their Pivotal Trials. It seems they have completed the Pivotal Trial of the In-market Device. They will have data this year, and then submitting them to FDA.

No, A pivotal trial could take 3 months to 7 years. And FDA can give a premarket approval application in 180 days ! (6 months)
FDA said that " The 180-day period for review of a PMA starts on the date of filing."

sources :
- Characteristics of Pivotal Trials and FDA Review of Innovative Devices : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4317185/
- https://www.fda.gov/MedicalDevices/...ubmissions/PremarketApprovalPMA/ucm047991.htm


Don't forget they have already datas from their preclinical study (university of pennsylvania) and 3 clinical trials on Humans, and one of their Pivotal Trial !

Initialy, the Pivotal Trial had to begin in 1Q 2017, and Follica has expected to a possible regulatory clearance in 4Q 2017. It's a clearance and not a submission ! And they said that just after the clearance, Follica will be on the market as soon as 2018.

If They have decided to begin a pilot optimisation study is for good reasons, and to improve the last Pivotal Trial. Don't forget, they are great minds, and not newbies.

 

[Noisette]

Noisette, since they're now testing their expansion protocol on human cells is there any possibility that things could go extraordinarily well with this present testing and the testing could wrap up substantially sooner than anticipated? And if that's possible could that speed up the time to get the treatment to market?

Good question. maybe this is one for @hellouser when he will be in Japan

 

[Christian Miller]

I think Hairblues is in love with Nameless!

Neh, It's That Guy who has stolen her heart.

 

[Omega2327]

Yeah I think that presuming a speedier timeline is a bit too greedy and overly optimistic. None of us know all the sh*t they actually have to do to truly make this successful. I would be ecstatic if everything just went as planned and they were able to commercialize in 2020. There could still be setbacks though, as we are all too familiar with. However, I do think a setback is much less likely now that they've seemingly solved their expansion problem. But they're certainly not out of the woods yet.. They still have to prove this sh*t really works in humans, and works well. The good news is that a 2020 release is even more probable than it was a year ago. We can only wait and hope for the best.

@nameless you should really post any questions you have in Hellhouser's Hair Congress thread. It'd be great to know as much as we can.

Also shoutout to @Noisette again for bringing us the best Tsuji news of 2017.

 

[nameless]

Noisette I would like to share an email with you that I got from Kerastem. I would like to see if you interpret it the same way I do. I interpret the email response (to me) from Kerastem to mean that they aren't excluding the possibility of requesting early market release for their Kerastem treatment after phase 2. What do you think?


My email:

I've been informed that the 21st Century Cures Act has passed, and if that's the case it might allow you to market the Kerastem treatment after the ongoing phase 2 trial is completed. You would still have to do the phase 3 testing but it's my understanding that you would be able to market the product after phase 2. Are you evaluating this potential option for early release?

Sincerely,

XXXXXXX XXXXXXXX

Eric Daniel's response:

Thank you for the note.

We are comfortable and committed to working with the US FDA on the appropriate pathway for Kerastem.

Thank you as always for your continued support.

Kind Regards,

Eric Daniels, MD

 

[nameless]

Yeah I think that presuming a speedier timeline is a bit too greedy and overly optimistic.

Like Gordon Gecko said, "Greed is good".

What's wrong with hoping that the ball bounces our way? In hair loss research the ball always bounces against us. Even when treatments work they don't work well and they have adverse side effects. Doesn't it seem like sooner or later the ball would have to bounce in our favor for once? Maybe the Tsuji timeline is when the ball will finally bounce our way.

 

[Omega2327]

Like Gordon Gecko said, "Greed is good".

What's wrong with hoping that the ball bounces our way? In hair loss research the ball always bounces against us. Even when treatments work they don't work well and they have adverse side effects. Doesn't it seem like sooner or later the ball would have to bounce in our favor for once? Maybe the Tsuji timeline is when the ball will finally bounce our way.

Nothing wrong with hoping for something.... But I try to manage hope with being realistic. They've said 2020 is their target assuming no major setbacks. So if 2020 is their best case scenario, I find it pretty unlikely they'd come to market before then.

But of course you're free to hope for whatever you'd like

 

[nameless]

seriously? the crappy kerastem scam again? kerastem in every f*****g thread now?
nobody cares about kerastem

Obviously I care about Kerastem. And if the FDA & Washinek report 20%+ positive results for Kerastem almost everyone else here will suddenly start caring about Kerastem too, especially now that Follica will not be coming out as soon as many of us thought it would.

 

[nameless]

lol. she can't stand him. as if any woman ever would fall in love with him.

Tell that to my 2 ex-wives and women who fell in love with me when I had my hair.

Check this out:

I'm presently in the process of pulling my criminal record so I can use it to apply for a VISA to get into Cozumel, Mexico when I cruise from Florida to Mexico in January or February. I'm pulling my criminal record for states I've lived in. I have no record except for a couple failures to appear (on traffic citations) when I was 19 years old. Since there are two of these convictions on the same date I thought it was a mistaken double reporting of the same conviction.
I was just on the phone with the main office of the dept. of public safety for the state where the failure to appear(s) took place. I explained to the adminstrative assistant (a woman) that I recall one court appearance so one of these convictions is probably a repeat notation of the same conviction. She said she would look into it and get back to me.
She called me back a few hours later and said the city where it happened sent her the information by computer. She said that there was one court appearance but 2 citations. She said I didn't show up for court twice. I was sentenced to 10 days in jail so there was a photo taken of me and the photo was included in the info that was sent to the administrative assistant who was on the phone with me today. She says, "Your picture is in here. I can see your picture. Your hair is long." The sound of her voice changed from professional to kind of giddy as she talked about my picture. I could tell by her voice that she was smiling while she was talking about my picture. She was embaressing me so I didn't know what to say so I just said, "Yes I like my hair long." She says, "I'm going to send you a copy of this picture." Still embarrased, I kind of flatly said, "OK, that would be nice, thank you." She was going on and on about my picture and how "youtfhul and nice" I looked. She was being flirtatious.

This is how things go when I have my hair.

 

[nameless]

Nothing wrong with hoping for something.... But I try to manage hope with being realistic. They've said 2020 is their target assuming no major setbacks. So if 2020 is their best case scenario, I find it pretty unlikely they'd come to market before then.

But of course you're free to hope for whatever you'd like

Of course I'm going to hope that some things get completed sooner than they originally anticipated so they can get the treatment to market sooner. I've got the money and I'm ready to go get it.

 

[d3nt3dsh0v3l]

I think Hairblues is in love with Nameless!

Neh, It's That Guy who has stolen her heart.

lol. she can't stand him. as if any woman ever would fall in love with him.

Tell that to my 2 ex-wives and the many women who fell in love with me when I had my hair.

Check this out:

I'm presently in the process of pulling my criminal record so I can use it to apply for a VISA to get into Cozumel, Mexico when I cruise from Florida to Mexico in January or February. I'm pulling my criminal record for states I've lived in. I have no record except for a couple failures to appear (on traffic citations) when I was a 19 years old. Since there are two of these convictions on the same date I thought it was a mistaken double reporting of the same conviction. I was just on the phone with the dept. of public safety for the state where this took place. I explained to the adminstrative assistant (a woman) on the phone that I recall one court appearance so one of these convictions is probably a repeat notation of the same conviction. She said she would look into it and get back to me. She called me back a few hours later and said the city where it happened sent her the information by computer. She said that there was one court appearance but 2 citations. She said I didn't show up for court twice. I was sentenced to 10 days in jail so there was a photo taken of me and the photo was included in the info that was sent to the woman who was on the phone with me today. She says, "Your picture is in here. I can see your picture. Your hair is long." The sound of her voice changed from professional to kind of giddy as she talked about my picture. I could tell by her voice that she was smiling while she was talking about my picture. She was embaressing me so I didn't know what to say so I just said, "Yes I like my hair long." She says, "I'm going to send you a copy of this picture." Still embarrased, I kind of flatly said, "OK, that would be nice, thank you." She was going on and on about my picture and how "youtfhul and nice" I looked. She was being flirtatious.

This is how things go when I have my hair.

 

[That Guy]

I think Hairblues is in love with Nameless!

Other way around, I think.

Neh, It's That Guy who has stolen her heart.

I don't steal hearts.

Kidneys are easier to sell on the black market.

Tell that to my 2 ex-wives and the many women who fell in love with me when I had my hair.

Will do, can you give us their phone numbers and/or link to social media profiles? You know, for a reference check?

 

[nameless]

Other way around, I think.

Well, you're wrong.

Look, I'm not putting anyone down or anything like that but just to be clear I have no interest in her. I'm not saying anything negative about her or anything like that. I'm just saying I do not have any interest in her and I never did.

She and I had one of the biggest quarrels this site has ever seen. When I have an interest in a woman I don't let disagreements get ugly. When I have an interest in a woman I sweep stuff under the carpet, I bite my tongue, and I ignore minor slights, in order to keep things smooth. So does the woman. If I had, had any interest in her that argument would not have happened.

But neither of us pulled any punches. What you saw in that quarrel is two people who do not care if they offend the other person.

I come here for the same reason everyone else does: I want my hair back. And I think everyone knows what my intentions are when I get my hair back. When I get my hair back I'm heading for the clubs. I'll be in the clubs prowling for hot babes. I'm into the clubs and the club women.

 

[nameless]

Will do, can you give us their phone numbers and/or link to social media profiles? You know, for a reference check?

Yea right, I'm going to give out the personal info of people I used to be involved with. Get lost you jackass.

 

[the smoking baby]

When I get my hair back I'm heading for the clubs. I'll be in the clubs prowling for 19 year old babes.

Buddy - if you act like this at clubs the same way you act on here, the only way you'll get 19 year old babes is with chloroform and duct tape.

 

[nameless]

* Because we depressed bald people are acting the same way here that we act when we have our hair, we're looking good, and we're out feeling good and having fun, right?

* If I get my hair back the things I do in the clubs will work fine so go give your advice to someone who needs it.

* And I'm not your buddy.

 

[nameless]

the absolutely crazy ridicolous thing is, Nameless is over 50 years old when he gets his hair back, and he doesn't even have a lot of money to at least look somewhat attractive to young women (ok he could pay a hooker). but he seriously still thinks he can just go to a club and get every chick he wants. he is just a delusional dreamer like i always say. we all know he will die alone... but let him just be how he is. in few years he will realize it himself, but of course then it will be too late.

What do you mean by "it will be too late"?

Are you saying it will be too late for me to die alone?

And I'm not over 50 years old. I'm not even 50 years old YET.

 

[nameless]

Hey listen up Joachim, I've been stuck in my place all day because they've been relaying the pavement at the condos all day. They just got finished so I can finally leave. I'm outta here. Have a nice time talking sh*t without me for awhile.

 

[H]

Hope I get my hair back before 50 I'm sick of being Hitman and Mr. Freeze for Halloween.

 

[nameless]

i said, you're over 50 when you get your hair back, in few years.

with too late i mean, in few years although having your hair back you will realize how dumb you were all the time. in your fifties you're not going to attract any hot girls just because you have hair again. when 19 year old chicks are interested into old guys it's only because of money. so you can pretend you're a rich guy and buy her for one night, but that's it. nothing spectular about it.
and then, soon you will be 60 and your life will be practically over anyway. so you're way too late with your masterplan. a better idea would be to settle down now with a woman in your age and enjoy the remaining years, or you will die alone.

That's all very nice but I didn't really care what you meant so I'm not going to bother reading past the first 5 or 6 words.