Fda Announces Comprehensive Regenerative Medicine Policy Framework

[RegenWaiting]

I believe this is definitely a step in the right direction, and to show why that is
I will quote the following from the press release:

''We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction.''

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm

All in al, better times are coming so I guess...

We're all gonna make it (BREH)brahs

...little positiveness can't hurt nobody

 

[RegenWaiting]

Also, in the latest Replicel newsletter they finish of by saying (and I quote again):

''In September, we alluded to BIG things coming.
That time has nearly arrived...
Stay tuned to hear more about our highly anticipated news.''

Wonder what that may be?

Also, they are saying (proudly) that they are devoloping cell therapies in Japan
in partnership whit Shiseido.

Maybe the issues between the two are resolved after all?

Will be interesting to see what they're alluding to!

 

[Jonnyyy]

Imagine they finally announce they're releasing their product, maybe we're meant to live a happy life after all guys.

 

[tjnpdx]

See, this is the kinda sh*t the holidays are supposed to be about. Merry thanksgiving to me.

 

[BaldyBalderBald]

Thx for this post, this forum is a feels rollercoaster, some days you get suicide fuel threads, and others hopeful ones
US will finally be able to compete with Japan on advanced medicine at last, i wish this was the same for France and others EU countries

 

[Xaser94]

Also, in the latest Replicel newsletter they finish of by saying (and I quote again):

''In September, we alluded to BIG things coming.
That time has nearly arrived...
Stay tuned to hear more about our highly anticipated news.''

Wonder what that may be?

Also, they are saying (proudly) that they are devoloping cell therapies in Japan
in partnership whit Shiseido.

Maybe the issues between the two are resolved after all?

Will be interesting to see what they're alluding to!

Can you please link the newsletter

 

[RegenWaiting]

Can you please link the newsletter

Took me a little time to actually be able to open it in browser as I receive it as mail.

https://us15.campaign-archive.com/home/?u=632bac2b90fc7021c812703ad&id=d6bd2a8473

Obviously, click on ''November 2017 Newsletter''

 

[NimuDash]

Imagine they finally announce they're releasing their product, maybe we're meant to live a happy life after all guys.

Imagine repeated injections grows back full head of hair on a baldhead like they initially wanted.
Lol, not gonna happen. We're destined to suffer.

 

[RegenWaiting]

Obviously it's a mistery what kind of big news they're alluding to, it could
very well be one of their other products, but in that case - it will also
give them much credibility as a company and their techology aswell!

So overall and in any way, we're definitely in for some good news soon-ish rather than later.

 

[Xaser94]

Honestly, if it has to with 21st century cures act then hopefully its that their regenerative treatments can come to clinic sooner. From what i can tell none of their treatments are for life threatening diseases. Is tendon sh*t that serious? Idk lol.

 

[BaldyBalderBald]

Honestly, if it has to with 21st century cures act then hopefully its that their regenerative treatments can come to clinic sooner. From what i can tell none of their treatments are for life threatening diseases. Is tendon sh*t that serious? Idk lol.

Hopefully, tendon problems can be painful and crippling, but it's just a step to others nervous regenerative treatments that can potentially involve many degenerative diseases, some deadly

 

[Ikkaku]

5 years again?

 

[barfacan]

so only 5 years until the fda allows for 3 year trials vs 5 year trials. yippie!

 

[Trichosan]

so only 5 years until the fda allows for 3 year trials vs 5 year trials. yippie!

Damn...I went from ridin' the Feel Train to sucking on a shotgun again in less than five minutes. Grim.

 

[inmyhead]

Any idea for phase 3 or are they just waiting for shiseido to be done?

 

[thomps1523]

Any idea for phase 3 or are they just waiting for shiseido to be done?

Will the fda allow them to submit the data from sheisido’s trials, so replicel doesn’t have to do phase 2 trials in the US? Anyone know?

 

[ALightInTheDark]

I feel the good and bad news in coming right now..
Like "Phase III will only take 6 months! We've already proved our efficiency and it regrows hair somewhat and sideless maintenance"
"But..It will only start by the end of 2020 since Sheisido has a hard schedule right there/any common excuse."

 

[Xaser94]

After taking a look at the documents they refer to released by the FDA about the 21st century cures act it seems everything that can be expedited def has to be for serious conditions or for things that can lead to even more serious conditions. The only thing that I can see qualifying for that is their tendon therapy . If someone took away something else from the documents refered to in that newsletter post it in this thread.