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

[That Guy]

I agree. I have given up on Follica coming out in a reasonable timeframe given that delays are part of their nature. Now my hope is for Replicel and more long term Tsjui.

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

 

[nameless]

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

Perhaps. But I doubt it. I believe that somewhere along the line there will be AT LEAST one more big delay from Follica. Old habits die hard.

 

[MrV88]

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

And how long will the pivotal trial take? How long will the approval from the FDA take? What would be YOUR realistic timeframe for Follica?

 

[MomoGee]

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

Unfortunately 6 months is far too much for us aggressive diffuse thinners, I just wish finasteride didn't give me any sides and I'd be one happy fellow at the moment.

 

[Endmymisery]

Unfortunately 6 months is far too much for us aggressive diffuse thinners, I just wish finasteride didn't give me any sides and I'd be one happy fellow at the moment.

For how long did you take finasteride? Did you recover fully?

 

[mdmnota]

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

We were expecting it a lot before 2018.

 

[MomoGee]

For how long did you take finasteride? Did you recover fully?

I used topical for a few months. After a while my manboobs became really sore and itchy with littles pebbles underneath my nipples. It went away within a few weeks of discontinuing though.

 

[nameless]

A setback of probably about six months is causing everyone to panic and act like it's the end lol.

It's like people were expecting it to come out Jan.1, 2018 or something.

Relax, their optimization trial begins imminently and pivotal trial begins after.

Please!!!!!!!!!!!!!!!!!

Follica recently indicated they have some work to do to make sure the scalp doesn't get burnt in the treatment process. This means that Follica is still working on the fundamental tech of their proposed treatment. Of course there will be at least one more delay. They may never solve that problem and the treatment may never come to market.

On the other hand, Tsuji has reports that they've worked out the final tech details of their treatment. This solves a big obstacle. I've been thinking that there's a chance that Tsuji's trial may start sooner than they previously projected.

* Follica = more delay(s), fundamental research still to be done, uncertainty if it will ever be viable.

* Tsuji = Technical problems solved, trials could start sooner than planned.

 

[Christian Miller]

Please!!!!!!!!!!!!!!!!!

Follica recently indicated they have some work to do to make sure the scalp doesn't get burnt in the treatment process. This means that Follica is still working on the fundamental tech of their proposed treatment. Of course there will be at least one more delay. They may never solve that problem and the treatment may never come to market.

On the other hand, Tsuji has reports that they've worked out the final tech details of their treatment. This means they really have no more obstacles. They just have to run the trial, and I've been thinking that there's a chance that Tsuji's trial may start sooner than they previously projected.

* Follica = more delay(s), fundamental research still to be done, uncertainty if it will ever be viable.

* Tsuji = Technical problems solved, trials could start sooner than planned.

It's Ok to be optimistic, but I prefer realism better.
They have clearly stated the trial should start in March 2019, if everything goes according to plan.

 

[nameless]

It's Ok to be optimistic, but I prefer realism better.
They have clearly stated the trial should start in March 2019, if everything goes according to plan.

Yea, but when they said the trial would start in March 2019 they said that before they figured out the solution to their expansion problem. Then about 6 months later they solve their expansion problem. What if when they projected that their trial would start in March 2019 they were thinking that it would take a year or so to solve that expansion problem? They may now be ahead of schedule if they solved their expansion problem sooner than they thought they would.

What is there left for Tsuji to do before they can start their trial that they had planned to start in March 2019?

 

[nameless]

March 2019 is a year and 7 months away.

With Tsuji's technical problems solved what will they be doing for a year and 7 months before they start trials?

I understand that there's paperwork and forms to be filed with regulatory officials and stuff like that. I also understand that they have to get everything organized and set-up. They may even have to do some kind of animal study before starting a human study but I'm not sure of that since Tsuji has already done some animal testing and Tsuji is using the expedited approval process. A year and 7 months is a long time from now and it does seem to me like now that they have their tech problems solved it shouldn't take a year and 7 months to get a human trial started.

Not only is there the chance that they solved their tech problem ahead of schedule, which might shave some time off the planned marketing date, but there's also the possibility that they were sandbagging all along about how long it would take to get the treatment to market. Perhaps their 2020 maket date is a worse case scenario date that they gave us so we wouldn't rely on the treatment hitting the market sooner. But maybe they really thought that if everything went perfectly they might be able to get the treatment into the marketplace sometime in 2019.

Now that their tech problems are solved and with so much time between now and March 2019 isn't there a chance that the trial might start sooner than March 2019?

 

[vernon]

maybe they will lay it out at the congress. another interview about their plans for that period would be nice too

I wonder what they will do until 2019

and are you ppl sure they solved "all their technical issues"? something is missing here

 

[MrV88]

maybe they will lay it out at the congress. another interview about their plans for that period would be nice too

I wonder what they will do until 2019

and are you ppl sure they solved "all their technical issues"? something is missing here

They could help Follica getting their sh*t together LOL

 

[nameless]

I'm not saying that I'm 100% sure that the Tsuji trial will start sooner than originally planned. I'm just saying that from what Tsuji has told us it sounds like their tech problems are essentially solved and there's a lot of time between now and the date they originally planned to start their trial.

I think I'm asking a good question - what will Tsuji be doing between now and the originally planned trial start date - March 2019? Can anyone explain what Tsuji will do for the next year and 7 months until the trial starts?

 

[Noisette]

Yea, but when they said the trial would start in March 2019 they said that before they figured out the solution to their expansion problem. Then about 6 months later they solve their expansion problem. What if when they projected that their trial would start in March 2019 they were thinking that it would take a year or so to solve that expansion problem? They may now be ahead of schedule if they solved their expansion problem sooner than they thought they would.

What is there left for Tsuji to do before they can start their trial that they had planned to start in March 2019?

Not true. You are really misleading people over there.
Doctor Tsuji answered me by email, and said that in July 2017. When you are writing some informations, please give your informations sources. If you affirm something you can't say that you have read it somewhere.

For example when you said that :

I read a recent quote by Follica wherein they said their pivotal study won't even start until sometime in 2018. I think they said it will start in March 2018 or May 2018. Pivot studies are at least 6 months and then you have to add on more time to organize the results and submit that info to the FDA.

No, Puretech heath has never said that. They said " the Pivotal Trial will begin after their pilot optimisation study, in 1H 2018. It could be in January as it could be in June 2018. Nobody knows.

I respect your point of view even if I don't agree with you. What matters is the informations sources.

 

[nameless]

Not true. You are really misleading people over there.
Doctor Tsuji answered me by email, and said that in July 2017. When you are writing some informations, please give your informations sources. If you affirm something you can't say that you have read it somewhere.

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

 

[nameless]

No, Puretech heath has never said that. They said " the Pivotal Trial will begin after their pilot optimisation study, in 1H 2018. It could be in January as it could be in June 2018. Nobody knows.

I respect your point of view even if I don't agree with you. What matters is the informations sources.

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.

 

[hairblues]

Not true. You are really misleading people over there.
Doctor Tsuji answered me by email, and said that in July 2017. When you are writing some informations, please give your informations sources. If you affirm something you can't say that you have read it somewhere.

For example when you said that :



No, Puretech heath has never said that. They said " the Pivotal Trial will begin after their pilot optimisation study, in 1H 2018. It could be in January as it could be in June 2018. Nobody knows.

I respect your point of view even if I don't agree with you. What matters is the informations sources.

View attachment 62717

 

[Trichosan]

Interpretation can be difficult here due to language differences. Here in US, "clinical application" generally means it is ready to be delivered to the public. Otherwise, in US, they would state clinical trial on humans, which would mean not ready for commercialization but further research testing for efficacy. Without clarification from Dr. Tsuji, we are still adrift.

 

[nameless]

View attachment 62724
Interpretation can be difficult here due to language differences. Here in US, "clinical application" generally means it is ready to be delivered to the public. Otherwise, in US, they would state clinical trial on humans, which would mean not ready for commercialization but further research testing for efficacy. Without clarification from Dr. Tsuji, we are still adrift.

Also, The email seems to indicate that Tsuji is now (since July) testing it on human cells.