Tsuji - News Successfully Developed An Expansion Method Of Hf Derived Stem Cells

[Hate da Bt]

That makes sense. But where is this from?
Is there a source or did you just come up with it?

Anyone here know the legal implications of this not being a drug?

Their human trial is to commence in March 2019, and they aim at a late 2020 (at best) conditional release. That's less than 22 months, in total.
Phase I trials usually last about 12 months, and phase II ones about 12-24 months.
If time for approval is added (3-6 months), we get an >24 months timeframe.
That means that either their therapy can be approved after phase I trials or that they have merged the two phases into one. Both are probable, but I believe it's the latter.

 

[DanielDüsentrieb]

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When i follow the "conditional approval" path in the first chart then it is possible to just do a phase one trial.
Isn t that what @Hate da Bt is talking about?

 

[razzmatazz91]

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What I'm asking is: is there only one procedure under PMD? Both for drugs and whatever this is, or is it separate?
What are the implications on the Tsuji method.

Their human trial is to commence in March 2019, and they aim at a late 2020 (at best) conditional release. That's less than 22 months, in total.
Phase I trials usually last about 12 months, and phase II ones about 12-24 months.
If time for approval is added (3-6 months), we get an >24 months timeframe.
That means that either their therapy can be approved after phase I trials or that they have merged the two phases into one. Both are probable, but I believe it's the latter.

So it is speculation.
Intelligent speculation, and what you say makes perfect sense. But it is speculation.

 

[Ollie]

Am i correct in saying they roughly priced Tsuji at 130k USD ?

 

[thomps1523]

Am i correct in saying they roughly priced Tsuji at 130k USD ?

Nobody has any idea what it’ll be priced at. Supply vs demand drives prices up, and it will initially only be offered in a very limited supply despite the substantial demand. Everyone can guess and assume all they want, but nobody knows a definitive price.

Quick question to anyone able to answer... Does Japan allow products permitted to skip phase 3 trials to be performed on those outside of its own country? I believe I read somewhere that those involved in the early release are still expected to be involved in what would have been stage 3 testing, but the difference is that it is marketable prior to completing stage 3.

 

[Trichosan]

Rather than guess about the cost, it would be interesting to calculate how long it would take to get the procedure done. Exclude the twenty day waiting period for growth of the cultured cells. If they separate the desired cells from the initial process by hand under a microscope, what would that take? 1/2 hour, 1 hour? Then, say there is an initial demand of only 10,000 patients, we have 5,000-10,000 hours of human labor to invest. And, I'm sure they won't be working 24/7. At that rate, don't be last in line if you're 50 years old. So, should we speculate about the possibility they have a way to mechanize this process, at least the lab part? But, I don't know that such a thing is possible when handling delicate tissue. (?)

 

[DanielDüsentrieb]

Rather than guess about the cost, it would be interesting to calculate how long it would take to get the procedure done. Exclude the twenty day waiting period for growth of the cultured cells. If they separate the desired cells from the initial process by hand under a microscope, what would that take? 1/2 hour, 1 hour? Then, say there is an initial demand of only 10,000 patients, we have 5,000-10,000 hours of human labor to invest. And, I'm sure they won't be working 24/7. At that rate, don't be last in line if you're 50 years old. So, should we speculate about the possibility they have a way to mechanize this process, at least the lab part? But, I don't know that such a thing is possible when handling delicate tissue. (?)

Vietnam isn't that far away. A normal academic person makes around 400-500 USD a month. So if they open a lab in Vietnam or another country with similar wage the manpower is no problem.
(Of course i have no idea how highly trained the lab staff has to be to do the job)

And anyway... if u calculate the working hours of a worker with 30 vacation days (included national hollidays) and a 40 hour week you get 1845 hours each year.
365/7*5*8-30*8=1845 h/a

So you just need 3-6 employees to serve the 10000 initial customers. So I dont see your point.

 

[Trichosan]

Vietnam isn't that far away. A normal academic person makes around 400-500 USD a month. So if they open a lab in Vietnam or another country with similar wage the manpower is no problem.
(Of course i have no idea how highly trained the lab staff has to be to do the job)

And anyway... if u calculate the working hours of a worker with 30 vacation days (included national hollidays) and a 40 hour week you get 1845 hours each year.
365/7*5*8-30*8=1845 h/a

So you just need 3-6 employees to serve the 10000 initial customers. So I dont see your point.

Exactly. Think about it. But also, I believe a minimal education level of certified laboratory technician, a 18-24 month training in the west, would be necessary for quality control.

 

[razzmatazz91]

Okay... this is nothing new, but I just felt like sharing this stuff: Some newpapers/News Agencies in Japan had reported last month on Tsuji's progress.
The Articles have no new news, and only vaguely mention trials on animals. I assume they are talking about the pre-clinical trials.

The articles I found are all the same, on Mianchi, Japan Times and Kyodo News.

Only real reason for sharing is the hope you and I get, my balding brahs.

One good thing one of these articles reminded me of is that RIKEN is government backed. That inspires some confidence, at least

 

[Mykonas]

One good thing one of these articles reminded me of is that RIKEN is government backed. That inspires some confidence, at least

Not really, the fact that they're government backed prohibits them from pouring money to the research team as it's considered financing a private institution

 

[Trichosan]

Not really, the fact that they're government backed prohibits them from pouring money to the research team as it's considered financing a private institution

You mean they can't accept additional funding from private sources because they receive money from the government? I can't find anything that relates to any restriction in any reports generated so far. Do you have a link? Also , I can't find any indication of a cap on government funding for them , so maybe it doesn't matter anyway?

 

[Mykonas]

You mean they can't accept additional funding from private sources because they receive money from the government? I can't find anything that relates to any restriction in any reports generated so far. Do you have a link? Also , I can't find any indication of a cap on government funding for them , so maybe it doesn't matter anyway?

Here you go my friend, riken issued lately around 4m $ in new shares to new investors to fund their pre-clinical trials. Tell me now how is "government backed" is necessarly a good thing if organ tech at this point still has to gather money from third parties ? also have any of you ever heard of conflict of interest ? that's the n°1 thing when it comes to government funding and the reason why no government on this earth can start funding or pouring money into private institutions it's even sometimes it's considered unconstitutional, unless the institution in question is tied to the whole economy also called "too big to fail" like private big banks it's the only case where government can give money. I don't think organ tech falls into that cathegory

http://www.organ-technol.co.jp/uploads/2018/06/82d8db3602b66cbe846c63317643c334.pdf

 

[Trichosan]

Here you go my friend, riken issued lately around 4m $ in new shares to new investors to fund their pre-clinical trials. Tell me now how is "government backed" is necessarly a good thing if organ tech at this point still has to gather money from third parties ? also have any of you ever heard of conflict of interest ? that's the n°1 thing when it comes to government funding

http://www.organ-technol.co.jp/uploads/2018/06/82d8db3602b66cbe846c63317643c334.pdf

I'm not seeing in there how they are prohibited from receiving government money in addition to private money provided in exchange for stock. I did express concern when this announcement came out about it possibly being an indication that they were not getting anywhere and needed additional money to continue operation. I'm less concerned now, maybe, and so I'll just leave it at that. Nothing else I can add.