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right place, right time imo
RMAT comes, buyout won't be far behind. I liked that AMGEN talk earlier lol
More 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 (Which I'm still digging into)
Now, we have GACP investing up to $5 mil more into US Stem Cell.
Then on Sunbiz, you find this:
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.
Woah check this out GACP is going deep into the stem cell world
http://florida-sunbiz.com/AgentDetails/NEITHARDT-DAVID
Pretty soon I think they'll have a new trophy to add to that list :)
Tic toc
Ahh yes that could be easily misconstrued. Seems as though it's from 2009ish
To me it's relevant now, in that, RMAT takes in clinical evidence OUTSIDE of current trials as well. Yes, US Stem Cell may have limited patients in their "clinical trials", but they have a TON of data like this from South America, Europe, and Asia. I'm sure the FDA is also reviewing that data in addition to the phase 2/3 marvel data.
So far, they've only completed a phase 1 trial for degenerative disk disease. They have not applied for any fast tracking on that... YET. Stay tuned for more on that though. I'd bet my left nut that they have plans for it.
Ties with Humana insurance >>
This is our investor's linked in (who's working very closely with usrm)
He's friends with the CEO of Humana!!
https://www.linkedin.com/in/joseph-dagrosa-jr-59415934/recent-activity/interests/
And I finally found dagrosa's ties to healthcare!!
On his linked in Click on "interests"
The CEO oh HUMANA is listed as an "influencer" to him
Connect the dots!!
Another Gottlieb article! >> RMAT coming
http://www.economist.com/news/business/21719841-scott-gottlieb-close-pharma-industry-knows-its-tactics-nominee-run-americas
Mr Gottlieb will certainly wish to find more ways of speeding drug approvals. The agency has done much on this front already. Yet inconsistency continues: some divisions of the FDA respond to routine inquiries from companies in a few weeks; others take three months. Mr Gottlieb has also criticised the agency for having a culture that values “excessive desire for certainty”. Attempts to change this will elicit criticism that patient safety is in jeopardy. Yet in some cases it is clear that the demand for ever-larger clinical trials of new drugs has done little for safety, raised costs and rewarded chiefly the very largest companies that can afford to run them.
One path will be to advance the trend for gathering evidence from trials that take place in the real world, not under tightly controlled conditions. GlaxoSmithKline, a British pharmaceutical group, recently completed the world’s first such test for a drug, Relvar, which treats asthma and chronic obstructive pulmonary disease. The four-year trial was conducted by monitoring thousands of patients’ electronic medical records.
Generic drugs is another area where Mr Gottlieb has signalled his views. In a commentary for the Wall Street Journal in August, he criticised the policymaking that had kept some generic medicines off the market, raising prices. He may want to tackle the rising cost and complexity of filing applications to market generic drugs—the problem that allowed Martin Shkreli, a controversial entrepreneur, to raise the price of Daraprim, an anti-parasitic drug, by 5,000% in 2015, causing fury.
The FDA also needs to run faster to keep abreast of innovation. Sudip Parikh, a policy adviser at the Drug Information Association, another think-tank, says the rate of change means that decades-old rules and regulations may not function well for new treatments. Some rules will be too restrictive, others too permissive. On the one hand, for example, more should be done to allow digital health-care products to escape the grasp of the FDA; on the other, the use of stem cells should face more scrutiny. Many clinics offer unregulated stem-cell treatments because of a loophole in the law. Three people were recently found to have been blinded by such treatments.
Another great Scott Gottlieb link! We're golden here...
https://www.google.com/amp/reason.com/blog/2017/03/13/scott-gottlieb-trumps-nominee-for-food-a/amp
Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR.
ZERO chance of me selling any shares here until buyout
RMAT coming!
The NEW FDA director is not only pro stem cell (adult type, sorry Harvard) but he's also all about making the FDA approval process friendlier towards new and innovative biotechs.
Scott Gottlieb is our savior. Get ready folks, rockets on the launch pad!
I'm still here and hoarding my shares!! Going lonnggggg.
Can't wait for those financials this coming week! It's gonna get crazy in here.
See you all tomorrow!!
David Neithardt too. Those guys are very.. what's the word. CONNECTED
Nice! The second leg up reacted identically to the first. Can't wait to see what the next leg brings, probly be ALOT bigger upon RMAT news
Awesome post hornet!
I'm gonna load more Monday!! Weeee
Happy Easter weekend to you all!
All while becoming a phd candidate!!
Definition for those who don't understand what it means to be a candidate
"Upon successful completion of the comprehensive exams, the student becomes known as a "PhD candidate". From this stage on, the bulk of the student's time will be devoted to his or her own research, culminating in the completion of a PhD thesis or dissertation."
Wonder what her research involves :)
Not too far fetched either, check this link from today
http://www.independent.co.uk/news/health/drug-giant-aspen-plot-destroy-cancer-medicine-big-pharma-times-investigation-a7683521.html
The FDA hasn't been friendly towards emerging biotechs, especially in the stem cell sector. In fact the FDA has made it nearly impossible for these emerging stem cell companies to progress.
That is the whole point of the Cures Act and the RMAT designations. To spur innovation in these new fields, allowing the companies to progress through the EXPENSIVE and burdensome FDA process, only available to big pharma in the past.
And guess what?! The FDA has a new chief in town, Scott Gottlieb, who just so happens to be a HUGE proponent of adult stem cell therapies. ADULT stem cells, the kind usrm is applying for RMAT designation.
Out with the old, in with the new. Usrm is getting ready to take over and it looks like they have a few new friends to help make it happen. One of their new friends apparently likes to throw money their way. Hmmm wonder why. Wonder what they know.
Many years, because the FDA hasn't been friendly towards emerging biotechs, especially in the stem cell sector. In fact the FDA has made it nearly impossible for these emerging stem cell companies to progress.
That is the whole point of the Cures Act and the RMAT designations. To spur innovation in these new fields, allowing the companies to progress through the EXPENSIVE and burdensome FDA process, only available to big pharma in the past.
And guess what?! The FDA has a new chief in town, Scott Gottlieb, who just so happens to be a HUGE proponent of adult stem cell therapies. ADULT stem cells, the kind usrm is applying for RMAT designation.
Out with the old, in with the new. Usrm is getting ready to take over and it looks like they have a few new friends to help make it happen. One of their new friends apparently likes to throw money their way. Hmmm wonder why. Wonder what they know.
Umm to get richer?
Expand your thinking here. What is the geopolitical climate like, especially between the east and west??
Possible trade breakdowns.. although trump looks to be more friendly with the east than we originally thought.
It makes perfect sense as to why they'd incorporate in the good ole USA.
Expanding their market. More money! That's the thing about the wealthy. They never stop trying to get WEALTHIER.
But I guess we'll all find out the truth behind this soon. Consolidated financials are coming. And imo they're going to blast this ship into another galaxy.
Later guys... this is my one post for the day since I'm in timeout!
Staying long here on dolv
One of the gacp heavy hitters >>
http://www.bloomberg.com/research/stocks/private/person.asp?personId=30393084&privcapId=29411606
https://www.linkedin.com/in/david-neithardt-7a52b0b1/
http://www.1848capital.com/team.html
The other names on the list have a lot of google results as well. Usrm has been working with gacp for a while though. It's in the filings.
Definitely not a fake company haha they've got some heavy hitters
Some big names on that list
This confirms to me that RMAT designation is very likely
1. The FDA asks for additional info (very common, I've posted FDA links verifying)
2. The FDA reactivated the MARVEL trial (why would they if RMAT was gonna be denied?)
3. Now GACP wants shares $5 million worth. Why would they bother if RMAT wasn't looking positive?
News out!
http://finance.yahoo.com/news/general-american-capital-partners-invests-153400134.html
Hmm now why would gacp want shares?? They must think price is going up? Maybe they know more about the FDA process than we do??
Why? There's really nothing more they can tell us aside from the hints they keep dropping publicly. I.e. Marvel trial reactivation.
Why would the FDA bother reactivating the trial if they were going to deny the RMAT designation?
Patience will pay out here imo
All clinical trial pages say that. It means nothing. We're just waiting on the FDA to finalize their decision at this point. Imo we will be approved.
Great article about our new FDA director...
Explains how too much regulation makes it difficult for newer innovative medicines to reach the market, crippling emerging biotechs. Deregulating the FDA would allow companies like us stem cell to withstand the expensive and arduous FDA approval process. RMAT is coming imo load up!
https://www.usatoday.com/story/opinion/2017/04/04/scott-gottlieb-fda-science-drugs-industry-campbell-berezow-column/100001336/
I noticed that a while back.
Then it was taken down and put back up.
Definitely some big forces trying to keep this down. Tells me to keep on buying here.
Why is this stickied?? Where's the news?
Well said! Spot on assessment.
Or maybe they have RMAT which will allow them to continue with less funding!
Seriously! Why would the FDA reactivate the trial without RMAT?! Think about!
The whole idea behind RMAT and the cures act is to sidestep the excruciating and expensive FDA process for new medical treatments.
Reactivation without RMAT would be pointless. So why would they do it??
It was a day trader. They don't care about the long term price. Only their daily gains. Pretty soon the pps won't allow them to afford to play with large blocks of shares here
The only logical reasoning for reactivion of the trial is because RMAT designation is coming imo
These trials are very expensive and without RMAT, the FDA knows it would be extremely difficult to continue the trials.
So the FDA wouldn't have them reactivate the trial if they weren't looking positively at RMAT designation possibilities.
Zjmy has a better ring to it imo
Yes, it's been posted many times. The FDA won't release it as it's not public record.
Staying long here let's goooooo!
If the FDA was gonna deny this they would be working so closely with us stem cell. Additional information, reactivation status. Writing is on the wall people. We're golden!