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That's less than 1% of the OS.. yes that would be considered low volume lol
lol at these low volume takedowns. Keep em comin kinda fun
Quote LOL "zero material events of significance"
Yeah so applying for an RMAT designation in a multi BILLION dollar$ market with a new head of the FDA that wants to expedite the approval process for new and innovative medicines isn't significant.
Oh yeah the new FDA director is also an outspoken supporter of the stem cell movement.
Yup, no material events. Oh wait funding coming from equity firms. Nope nothin material there lol
Oh there's been elimination of toxic debt?! Haha nope not significant.
He's %100 correct on that perspective too
Reread the RMAT process on the FDA website lol that's not how it works
You gotta remember that RMAT is new and anytime the government rolls out a new protocol or procedure there will be growing pains. There is nothing in writing, anywhere online, relating directly to RMAT timeline procedures after additional information requests. That's a fact.
There is plenty of information regarding other approval processes timeline, but not RMAT. I challenge someone to please prove me wrong here.
Just gotta have faith here. It's a new FDA program and they are being cautious. The good news is that the new director of the FDA wants faster approval processes for new treatments like the ones that usrm are proposing.
With the shanghai auto show kicking off, Fins will no doubt make some international noise.
Imo the longer they take to get out the better. Means there's more meat in them that need to be audited. Ahh the anticipation.
Could you imagine, financials that show some CIC backing, and billion dollar contracts. WOW
Have a good one today dolvers
Let's see what the powers have in store for us today!
They had 20 patients in the completed trial at time of RMAT application. Same as usrm.
08+ close easily
Lol someone literally posted a screenshot of an email reply last week
Additionally, the FDA needs to see that usrm has the financial means to accommodate an RMAT designation and reactivated phase 2/3 trial.
In steps GACP with $5 million on hand.
Ball is now in the fda's court
The CEO told us in today's blog post. January 27th.
The entire RMAT process involves them to actively work with the FDA. Either way, I doubt the FDA just put the paperwork on the bottom of the pile and put it off. I highly doubt we'll be waiting 60 more days but it's all good. I'll hold here regardless as I'm sure you are too.
I think you're reading that in the wrong context. Again jmo.
But it sounds like they are just affirming that they are working with the FDA and providing answers to them in a timely fashion. There could be more requests, in which case they'd continue to provide them supplemental info in a timely manner. But for now, it sounds like the FDA received what they wanted and reactivated the ind/trial.
The RMAT process involves them working with the FDA
Exactly, RMAT is designed to allow companies to work with the FDA on new and innovative regenerative medicine. It allows the FDA to monitor this new sector, without inhibiting medical progression.
The new head of the FDA wants this to succeed. He's a big supporter of this movement.
It appears that us stem cell is working WITH the FDA to get this ball rolling. It may take time as this is a NEW program for the FDA. But the transparency here is a great sign for the future. Good thing coming
Did you read the blog?? The CEO said the clock reset. So they have a few more weeks atleast, but I doubt it takes that long
According to CEO clock reset
January 27th applied for RMAT
Sweet! I'll buy a few more shares today!
They will. Chart looks beautiful.
See cheds chart.
Patience people!! Let wang do this the right way.
We know it's coming. (Intended within 2 weeks of the pr puts us at Thursday/Friday)
We know Oravec just had major surgery, so I'm sure he's a little behind as well.
It's not gonna be some bs financials that they threw together to assuage the shareholders.
These consolidated financials will likely be detailing some big moves with big money. THEY WILL COME!
People just patiently waiting. Low volume indicates most are holding for the good word.
Let the mm's and FDA do their thing
Yup! Lol down on 10 mil volume. That's nothing. Nobody is selling here because the fun is about to get started
Upon RMAT designation usrm can begin commercialization of Myocell
Another paint job! Smh .. Green is a nice color though.
Let's go wang! We want to see the financials!!
*RMAT
Great post and very likely what we're seeing
Feb was two months ago.. and the company will be announcing the FDA decision to the public, not the FDA. So the company decides when it will be released, and based on their pr history it likely won't be a Monday.
Exactly!!
The show will soon roll
The FDA is holding the string on the curtain tho
Exactly. With RMAT designation, usrm will have no problem finding funding lol
It will turn into a bidding war. Gacp wants to lock down those shares before it happens
ontop of the $2.5 mil to open the 10 clinics
Gacp wants RMAT just as bad as us.. hopefully they've got some little birds flying around the FDA
But gacp wants those shares.
Because after a RMAT designation, they become a guppy in a sea of sharks.
Those shares will make them a lot of money. They're betting just like us
A lot more going on behind the scenes here.
The names involved now. Borman, Dagrossa, neithardt..
That's just on the business/financial side
RMAT = bidding WAR on a massive scale
Let's go FDA, we all know you have sufficient data
Some GACP / USRM dd for y'all...
US Stem Cell has the leaseback agreement and investment of $2.5 mil from GACP to open 10 new clinics. In the details there is a non-compete agreement of course.
Then US Stem Cell announces the Advanced Stem Cell RX partnership (gacp has to be connected here somehow)
Now, we have GACP investing up to $5 mil more into US Stem Cell.
Then on Sunbiz, you find this:
http://florida-sunbiz.com/AgentDetails/NEITHARDT-DAVID
NEITHARDT, DAVID GACP STEM CELL HOLDINGS LLC L17000005392
NEITHARDT, DAVID GACP STEM CELL BANK LLC L17000005409
NEITHARDT, DAVID GACP STEM CELL CLINICS CORAL GABLES LLC L17000005411
NEITHARDT, DAVID GACP STEM CELL CLINICS LLC L17000005412
NEITHARDT, DAVID GACP STEM CELL MANAGEMENT LLC L17000023667
NEITHARDT, DAVID GACP STEM CELL INVESTORS II LLC L17000023676
Now, while all of this is going on, US Stem Cell is patiently awaiting news on the RMAT designation from the FDA. It seems as though, they are actually working with the FDA on the designation. The FDA wanted more info and they got it. Then the Marvel trial was reactivated. Why would it be reactivated if RMAT weren't a legitimate probablilty?
David Neithardt is a pretty well connected individual it seems. And his credentials for acquisitions / mergers are also pretty well known (heartland food and Burger King) Also, his Stanford undergrad and Dartmouth MBA look pretty nice.
His partner at GACP is Joseph Dagrossa who is also a big dog in this game (i think Vita posted links on him earlier) .. On his linked in, he has the CEO of HUMANA listed as an influencer. hmmmmm
So, the dots are starting to really show up but we need a few more until i think they can really be connected.
New ticker: ZJMY or WANG
Hmmm
Agree, Broome share some DD and chill on the caps please. I like your enthusiasm.
Me personally all black Porsche 911
We should see an 8k explaining it this week. Maybe we'll get a couple 8k's this week