Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Yup, I'm with you oh your theory (ies). It's been easy to from load because most of the news has been expected. The next news may be unexpected and probably for the best.
There's going to be a split but the share price appreciation post split will be worth it so it won't be as detrimental as most fear.
I for one prefer a split and trading on Nasdaq as compared to pink sheets with all it's downsides. That's my 2 cents.
Please be mindful of the difference between OS and AS.
I'm with you, except clinical trials is a super expensive undertaking and has the potential to keep out smaller companies with little cash to burn from bringing their products to the market unless they partner with one of the big players. I think they need to focus on Myocell and Myocell SDF until the FDA gets it's act together with clearer guidelines for those in the SVF therapy space.
I'm not sure why they would need to acquire the remaining 42% when any percentage ownership above 50% gives them a controlling interest and allows them to book 100 revenue of Rotmans furniture on Vystars balance sheet.
I hope folks realize that the snippets from the court documents are not as widely disseminated as an official PR. Only ihubers and a few others are in the know for now. Once the PRs drop the price action will be different from todays'. IMO.
you're correct in that it is a memorandum in support of a motion. The judge is yet to make a pronouncement on the issues but some of the information in the memo is very juicy. Note that the entire memo and all representations to a court are made on the pain of perjury i.e. you can get into serious trouble by lying to a court.
A/S is 975 000 000. page 14 of memorandum in support of motion to dismiss.
this was filed March 22 titled Mediators report.
Pacer. It's all there.
Mediation report out. No agreement between the parties at Mediation. Consent decree entered for one of the defendants....
I understand your concerns however the OTC world is weird like that. The price action does not always align with fundamentals or expectations ... until it does.
The risk of r/s here is low imo. Insiders own quite a huge amount of common shares.
Please share case number. I can't find it on my pacer. This was filed in NY southern district? Thanks.
It might not take that long. The facts here are largely undisputed. I expect one party to prevail on their motion for summary judgment.
I agree. I was expecting one to be announced by now. I suspect the company's focus has shifted somewhat to the lawsuit. Maybe once that's settled we'll get an update on that. fingers crossed.
The RMAT application was with respect to Myocell product. The lawsuit is about the activities at the clinic. Seems like they're still looking for a partner to help with commercialisation of Myocell.
Yes, extension of discovery to allow deposition of one of the FDAs expert witness. The court has allowed the extension.
they better get on that cos some brokerage firms won't allow clients to trade this until the stop sign is no longer.
what platform are you guys using to trade NNRX? Having issues with my broker. thanks in advance.
Whatever the merits of the FDAs case against USRM, one thing is clear for all to see i.e the science is promising and other players in the industry know this.
Best case scenario USRM prevails- etablishing itself as the industry leader it claims to be.
Worse case scenario USRM loses forcing it to partner with a bigger player to fund clinical trials in the US or concentrate on ex US expansion.
This is all very interesting. Either way, these prices won't last much longer IMO.
If a few cases of adverse events is all it takes to sink a company then most pharmaceutical companies should be out of business.
The mediation was mandated by the court. If there is no resolution through that process, then pre trial conference in May then the trial begins in June. Currently the parties are engaged in discovery. it looks like they have agreed to a phased discovery approach with phase II ending somewhere in Feb next year. Mediation is set to conclude a few wks after. That's the timeline I gathered from going through the docs. Keep in mind that there could be a settlement at anytime.
Doubt it. The defendants did not raise it in their answer to the complaint.
Generally true. Discovery is for unearthing facts. In this case, the relevant facts are largely known and undisputed for the most part. This case rests on statutory interpretation IMO. Interested to know which experts USRM will be calling on to testify... that could be key.
The parties submitted their plan for discovery to the court. The court asked for clarification of the plan. In response, the parties filled a joint statement clarifying the plan. The trial itself won't start until after discovery.
If your contention is that the rules you're accused of violating do not apply to you, why respond and give legitimacy to that accusation? I think that's the view the company took at the time.
The defendants are US Stem Cell LLC, US Stem Cell Inc. ( trading as USRM) and 2 natural persons. US Stem Cell LLC owns and operates the clinics. It is partly owned by US Stem Cell Inc. (USRM).
So all the entities are represented, in my opinion.
ya, understandable. They need to get Myocell SDF commercialisation more serious consideration now than before since it will be a while before there is clarity on the in clinic treatments.
I disagree. If it didn't work, I think ppl would be more vocal about it because of how expensive it is and the outrage more widespread and probably more lawsuits than 4.
No, the court does. Besides, the FDA in their article last year mentioned that it was going to give companies in this space 3 years to bring themselves into compliance. So why this action all of a sudden? I think it's Sen. Grassley 's letter more than any public health reasons.
If the treatments were so dangerous, the clinics would be out of business without the help of the FDA. Buy what we're seeing is quite the opposite. Hundreds of testimonials from successfuly treated patients and 3 lawsuits from treatments which have been discontinued. Not a bad track record at all and certainly far better than most pharma companies can say for their breakthrough products.
I doubt you'll find much case law on point and that's the whole idea. There's a genuine legal question to be answered here once and for all.
Does the manipulation of adipose derived autologous stem cell as is performed by USRM clinics enough for it to constitute a "drug" as defined by the regulations and thus bring it under the preview of the FDA?
KC and crew contend that it is not and have been looking for this fight since August of last year with their response to the warning letter. Not sure whether this injunction will be granted but we're definitely set for a legal showdown.
Either way, not good for business in the short term. In the long term, once this issue is resolved and if USRM comes out on top, USRM will cement it's place as the leader in the field. If USRM loses, well, there goes 33% of revenue stream until FDA figures out how to regulate this emerging field.
so, place your bets people.
Go USRM!!!
You mean 2 years. Even that is ambitious but hope it is so.
Northstar Biotech is also loading.
Insiders still loading.
if there's a silver lining to any of this it's that USRM now has national exposure thanks to the FDA. Once this regulatory cloud lifts we'll be on our way.
That's one thing I prefer they don't do. A small company which supposedly decided not to rapid to the FDA request for more information in pursuit of RMAT now wants to spend money in a legal battle with the FDA? IMO that's not smart business so o guess we disagree. And btw courts will generally defer to the FDA when it comes to interpretation of their own rules. Hoping for the best here but this regulatory squeeze isn't helpful.
The last I checked the letter was not sent to my private email. I'm not here to argue just stating my opinion. The truth is the company could have handled this better. In fact they seem to have a particular disdain for the FDA which is worrying. Unless they plan on only doing business outside the US they need to tone it down.
A public showdown with the FDA is bad for business but I wonder why the warning letter would be made so public.The company's response leaves much to be desired. ..a simple public statement would have sufficed while they worked to bring the clinics in line with the FDAs demands. No one wins by arguing with the referee.
Granted this is only a fraction on their business but their reputation is now stained. They need to get their act together fast and quietly.
it won't be the first time that a stock has gone down on good news.
Could be for any reason or no reason at all. .kinda hard to tell what it could mean for shareholders without more information. But at the very least the company will save legal fees and costs in that regard. ..IMO.