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STICKY THIS PLEASE
That was a VERY informative post and solid DD. This should be stickied, but it probably won't be. Cheers to you sir
In an age where trying to minimize insurance costs is a very hot topic. I like it. A lot.
Was cordis a scam too?
Well I fully agree with you regarding breitbart.
It's an article singling out a few cases where stem cell treatments didn't produce the outcome they were expecting. You can write an article like that about ANY medical treatment, can you not?
Down to 2 stars here! Thank god, maybe they'll short somewhere else this week.
Since we're posting predictions...
Open Monday and immediately gap up to .13. Massive shorting ensues. The board goes crazy.
Price begins to drop. On no. What happened. My L2 doesn't show anything? Huh?
Boom. Halted bitc$s. Opens back up. Gap to 1.15. Yup. 1 freakin 15. Keeps going up. doesnt stop. Ihub crashes. Again. Shorts wallow in their tears. Glta
i thought Friday was gonna be .02? Ugh I was really hoping to load up
I love you
Usrm is about to blast off!
In pacer filings. Nobody knows who, thatd be confidential to the company for sure. Leverage is everything at this juncture
Hey cracka, I think you posted about one of our competitors getting denied by FDA. What was the companies name? I tend to believe that them being denied would be great for us stem cells chances.
Nvmnd I found your post. Cheers
How'd his last company turn out??
Still irrelevant if you're holding until FDA news. It's no longer an if but when. Who cares what happens until then?
I truly think they got positive feedback from the FDA and are just finishing up the paperwork now. Tomas is a smart man
I did some digging as well. Gotta look at the codes.
The older form 4 was code P ( open market purchase)
The most recent one is code M (exercised or conversion of derivative or security)
Either way, the man is loading up right now so I'll follow his lead haha
Found a good explanation of Form 4
Am I missing something though, says it must be reported 2 days after transaction
https://www.sec.gov/files/form4data%2C0.pdf
So let me get this straight...
On 3/29 Mr. Murphy buys almost 2 million shares (correct me if I'm wrong, not an expert on reading form 4s)
On 3/30 we receive a nice lil PR from Tomas explaining the additional info request (very common, read my posts on that) and that they are working with FDA on RMAT designation.
3/31 the form 4 goes public
Can they make it any clearer for you doubters out there??! Come on lol obviously they know this is a done deal
The patents are preserved as a part of the cures act. Maybe go read the cures act.
Hmm the chance to make hundreds of thousands $ or lose $2k invested at .02 lmao I like my risk/reward there
I will love you forever.
Great question stock whale!
Huge bids! Jesus Christ
Guess the prophet may just be right.
That's because industry insiders know what additional information requests and substantive interaction between sponsor and FDA mean. Imo we are set
Great read from the FDA. The fact that the PR states they are working with the FDA could mean this baby is a done deal.
https://www.fda.gov/RegulatoryInformation/Guidances/ucm341918.htm
I like the word complete here:
b. Timing of Substantive Interaction
Substantive Interaction should occur following acceptance of the submission and after FDA has performed a complete review of the submission and within:
60 days of the receipt date of a complete submission
Additional information requests is common READ
From an FDA analysis
Since 2002 the number of Additional Information (AI) Letters per submission that the FDA sends to sponsors identifying questions they need to address – what are called “cycles” – has increased (see Chart 2). And, the percentage of submissions for which the FDA sends an AI Letter has also increased steadily since the start of the user fee program
Our analysis showed that, in the majority of cases, the FDA appropriately chose to send an AI Letter. These cases include, but are not limited to, circumstances where: (i) the sponsor did not submit required information without justification – such information includes supporting data required under current guidance or performance data that FDA consistently requires for certain device types; (ii) the sponsor failed to identify a predicate; or (iii) the sponsor employed different device descriptions or indications for use for the subject device throughout its submission.
200,000+ reads last night. The new FDA news must've got some attention
5 million share bid yesterday. Insiders know what's up.
Has the prophet returned?!
Haha I know bro. Believe me
I'm ready
This the one? Lol
Long at 02..
worst case scanrio I lose a few bucks. Best case scenario I buy a new house and put gold plated rims on my crown Vic. I like my odds
Agreed.
The slaps usually start showing up big around 2:30. Let's see
Usrm taking a nice little nap. It's exhausting going up a few hundred percent in a week lol she'll wake up soon I think
J. S. Landow, M.D.
Managing Director ASC
Dr. Landow, has been involved in Healthcare for almost 30 years and he is currently the Managing Director of Advanced Stem Cell Rx, which is building the largest network of autologous stem cell treatment centers in the US.
Dr. Landow first became engaged as a healthcare consultant over 20 years ago, and has worked with several of the largest and nationally prominent Health Systems along with numerous Wall Street firms and advising on medical-industry acquisitions, IPO’s and recapitalizations involving biotechnology, bio-medical devices and healthcare service companies.
In 1994 he founded New York Medical, Inc. (”NYM”), one of the pioneering practice management companies. NYM quickly established itself as one of the region’s leading specialty practice management entities, offering extensive vertical integration and turnkey solutions. and encompassed the following specialties: neurology, spine and orthopedic surgery, pain management, physiatry, physical & occupational therapy, acupuncture, and internal medicine.
He has served on the Medical advisory board for the Juvenile Diabetes Foundation and the development board of The Feinstein Institute for Medical Research, which is the research branch of the Northwell Health. Dr. Landow earned his B.A. in Economics at Vassar College in New York, subsequently completing an M.S. in Nutrition and Biochemistry at Columbia University in New York. He earned his M.D. at the University of Miami, School of Medicine.
Very heathy dip here.
RMAT timeline
I know it gets lost in all the optimism here, but nobody actually knows. I even emailed the FDA for the hell of it and of course I got the response that it is not public record.
What we do know is this: US Stem Cell was one of many who lobbied in front of congress to bring about this new regenerative medicine designation. So logic tells you that they likely didn't wait months to apply for the designation. Why would they?
Many here, including myself, believe that they applied during the first couple weeks the FDA began accepting these applications. Some have speculated that because the clinical trial .gov site was updated the end of January that it confirms this. Could be a coincidence but who knows. Personally I believe news could come any day within the next couple weeks. Maybe tomorrow after AH. But that's my opinion.
Worst case scenario, they didn't apply until march 13, when the CEO announced it via his blog. Why would they wait that long? Maybe to get their ducks in a row. Dot their i's and cross their t's to minimize any setbacks. They wanted to make sure their application was perfect. Again, I doubt they would've waited, but this scenario would have us waiting until first couple weeks of may.
So this is my take on the RMAT designation timeline
I know it gets lost in all the optimism here, but nobody actually knows. I even emailed the FDA for the hell of it and of course I got the response that it is not public record.
What we do know is this: US Stem Cell was one of many who lobbied in front of congress to bring about this new regenerative medicine designation. So logic tells you that they likely didn't wait months to apply for the designation. Why would they?
Many here, including myself, believe that they applied during the first couple weeks the FDA began accepting these applications. Some have speculated that because the clinical trial .gov site was updated the end of January that it confirms this. Could be a coincidence but who knows. Personally I believe news could come any day within the next couple weeks. Maybe tomorrow after AH. But that's my opinion.
Worst case scenario, they didn't apply until march 13, when the CEO announced it via his blog. Why would they wait that long? Maybe to get their ducks in a row. Dot their i's and cross their t's to minimize any setbacks. They wanted to make sure their application was perfect. Again, I doubt they would've waited, but this scenario would have us waiting until first couple weeks of may.
that's how I imagine it going down. Let the excitement build up all weekend. Give it time to spread. Then Monday morning pops