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Yes. Opportunity is there because USRM is oversold imo. Day traders plant a seed and then stare it. Investors plant a seed and walk away.
I definitely agree with that for the short term. But I see a great opportunity for USRM to get FDA approval this year. FDA approval provides legitimacy and that creates real wealth. Working around the FDA is like putting off studying for a final exam. Competition is coming. Gottlieb wants stem cell treatments to be available. The FDA is the correct pathway to success imo.
I think there is more pain in store before the bounce (hope I'm wrong). Q2 will help. Looking at the big picture now. I expect Tomas will state they are renewing their effort to go after RMAT now that the guidelines will be released Sept. If Texas really is in play then the increased revenues from that clinic, along with the others, will help to offset some costs associated with RMAT and eventual FDA approval.
That's possible. The blog might be useless. I see things right now at a turning point for USRM.
The disastrous blog last month was premature as it turns out. I was not expecting the FDA to finish their guidelines until sometime end of year (we are talking about the government after all). Things have changed now. The question is will USRM respond?
USRM needs to build bridges with the FDA not talk about how to handle unwanted visitations in a seminar. WTF? Drop the rebellious attitude. Get with the program. RMAT is an absolute necessity.
CEO blog cometh soon imo.
I better see a blog that states USRM is reengaging in communications with the FDA now that guidelines are to be released in September. RMAT is an absolute necessity now if USRM plans to compete.
For me, .02 is a reasonable expectation in the short run (maybe this week) as long as volume stays strong imo. The time to buy is now because audited Fins will send this much much higher.
With the FDA's guidelines coming out in September it is imperative that USRM gets back in the game for RMAT now. Skepticism will grow if this does not happen immediately. Why continue to hold shares if RMAT is not being actively pursued? Please someone tell me why?? FDA guidelines have now made the investment for RMAT justifiable. I see a pivot point right now. Which direction is Tomas and the BOD gonna go? Legit or...?
Been holding since early January. Being a contrarian cost me big time here. My perceptions and expectations of USRM have now changed. It's time to poop or get off the pot.
"an RMAT designation would most likely mean that we are allowed to sell the therapy, but must continue reporting to the FDA what happens during treatments.."
But without guidelines that wasn't going to happen imo because Marvel was too small of a sample size. Everyone keeps talking about getting RMAT and away you go and it just isn't that simple. For instance, how many patients need to participate (minimum) for the FDA to consider reasonable sample size? What are the parameters that will determine a successful result? What is it the FDA is looking for? The FDA talks about working together with businesses to assist in the process of developing these treatments for public use. That MUST mean that they are willing to allow businesses to earn income during the process to help offset costs associated with ongoing testing.
Tomas and the BOD must rethink their plans not to pursue RMAT now that the guidelines will be out in Sept. This changes everything imo. RMAT needs to be back on the table or I'm out. I don't want to be invested in a grey business long term that has the opportunity to be legit. Nationalization and insurance billing is the goal here (along w/BO). USRM will be left behind. Why pay cash when you can get the same treatment under insurance coverage?
USRM needs to make up their minds. Do they want to be a part of the herd or do they want to lead the herd?
Tomas - it's time for another blog.
I asked a similar question earlier. Around 24 RMAT applications w/4 approvals. That leaves the status of around 20 apps unknown (USRM) being one of them. Things are unfolding right now very rapidly in USRM's favor imo. The FDA may have been stalling until guidelines were set. I think the small sample size for Marvel put USRM into a grey zone imo. Hopefully the guidelines will provide a pathway to move forward allowing treatments to qualify as a part of the study that would lead to approval for commercialization nationally. Texas legislature and right to try should provide the environment for this to happen. I DO NOT believe it was a coincidence that the FDA's guidelines will be in effect by September imo.
September huh. Just happens to be around the same time of Texas' new right to try law implementation? Things might be getting interesting here. The FDA doesn't want to be left behind it would seem.
Granted 4 out of around 24.
How many were denied? How many are still being reviewed?
Were does USRM fit into this?
Lots of unknowns.
Do we Gottlieb this? I dunno.
Thinking about taking a position Monday.
Would like some info please:
What is the significance of the merger?
RAD is a start up with potential but is there an indication for strong revenue potential?
What are some of the expectations with this acquisition going forward?
I like the O/S and float. Volume is building nicely.
Thank you.
Nothing ever moves quick enough to satisfy investors (me included). Don't stare at the ticker..:)
Because straight talk is a rare thing in the stock market (OTC and Nasdaq)especially in blogs and tweets imo.... Straight talk involves more risk than being deliberately vague (not misleading - there is difference). There is far more accountability with straight talk > put yourself in the place of the CEO and BOD and then ask yourself what are they thinking? Learning how to read between the lines has it's advantages too (if you are correct).
GLTU
Nice post.
I would still appreciate an official explanation of some sort regarding the 9 month or so delay (doesn't need to be detailed for obvious reasons) instead of tweets that have the appearance of a circular bread crumb trail.
I think Arrayit has amazing products and potential.
I am holding long for now but stop sign hurts...
GLTA
Great point Jake. I imagine Gottlieb has his hands full. I wonder if the FDA appointed a new director yet? Last I checked about a month ago it was vacant.
Just for fun, I recently sent a couple of emails to the Senate Health Committee Chairman Sen. Lamar Alexander (strong supporter of Gottlieb, and right to try, and stem cell tech)summarizing what I've witnessed with USRM's attempt to get RMAT designation and the hurdles they've encountered. Sen. Alexander probably won't see the email but you never know unless you try.
USRM..:)
I hope you are right e. I know your girl needs a new truck if I remember right..lol. Maybe a diesel crew cab with stacks?..:)
USRM$
Hey EZ. I hear yeah. I have other plays too although I am heavy into USRM since beginning of year. Sounds like you've made some good decisions - congrats. I am at a point with USRM where I feel I need something which is illogical because I bought with the idea of this being a long play. I need to chill a bit..lol.
Glad you are here.
Very good read. Very encouraging. I dunno. I like to maintain a healthy skepticism, but damn, things look like they are on the verge of exploding from the top down in a very good way. Sometimes I feel like we (USRM/investors) are ahead of the curve. Maybe I should calm down a bit.
I think the FED is really focusing in on opioids right now (poor big pharma). Lots of political pressure to significantly reduce their use. This will play nicely into the hands of therapeutic treatments like stem cells which treat the cause not the symptoms.
"But does the FDA have the man power, or do they even care to go to texas and stop stem cell clinics from selling therapies that go against FDA protocol ?"
Considering the numbers of other stem cell clinics currently in operation nationally, I think it is unlikely the FDA will try to interfere - I expect that would already be happing and it isn't. I think the FDA will monitor the situation for now. In some ways this is not unlike the state MJ laws.
"And though the Texas law says that it applies to stem cell treatments currently under investigation in clinical trials, it also blocks the Texas Medical Board from revoking, failing to renew or suspending a physician’s license “based solely on the physician’s recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment.”
That is very good!
Vey nice post as usual.
"We will need a catalyst" > Q2 should do that in the short term.
"...we can determine that this play is not over yet" > Yes.
"...will serve as a good plan B should RMAT not come through." I see it the other way round. Texas as plan A, RMAT an afterthought as is buyout.
I see Texas as the big ticket because it will allow USRM to conduct business without the threat of the FDA interfering (the scope of their practice will be dependent upon provisions within the legislation +/- MyoCell). Other states will most likely follow Texas but it will take many months of special interest involvement to get it passed into law.
If USRM does not provide convincing evidence that they are actually opening a clinic in Texas before year end I will most likely begin to reduce my position after holding since 1/01/17 (other people will happily snatch the shares).
If RMAT status is granted that changes everything, but I remain skeptical because there are no guidelines...yet (something we should have been cautioned of back in January).
Good luck with that.
ARYC$
Lets go USRM$
Interesting.
2 weeks ago. Not 2 months.
Q2 is coming soon. I am waiting for that to make my decision going forward. Q2 is not a means to an end, but it will provide guidance. USRM could post some news in the meantime, either way I will reassess after Q2.
Hopeful.
Dog days of summer maybe.
Need something.
Lets have a green day.
I understand all that, but..
Audit needs to happen. Will wait a lil while.
I see >> quote...
Promo isn't all bad I guess.
I hold a large position here. I have done a fair amount of DD, but longs like yourself are light years ahead (I respect that). I have some healthy skepticism, but overall I like what I see.
I appreciate your response.
Better save your post count for the day..lol
"Why now of all times are we finally attracting all this attention. Hmmmm......wonder why?"
Okay I'll bite, why?
Looking to get cheapies?
Agree.
"If your watching ..expect burning sensations and a knot in your stomach!!"
lol
I'm still holding strong :)
Good to hear my friend.
USRM$
Lets go USRM it's time to wake up.
Positive feedback hopefully means completion very soon.
Audit will be a huge catalyst.
Now is the time to accumulate while it's still cheap.
Macular degeneration LOL. Risks are Omni present with any medical procedure or medication.
Go USRM$
Nice.
"Arrayit receives new financing lead that could generate 6,000 x $100K = $600MM in Arrayit microarray platform sales
http://arrayit.com"
ARYC$
I haven't reviewed any clinical studies from Europe..yet. It really isn't about safety as I described earlier, its about efficacy (the potential to achieve desired results). From my knowledge about stem cells treatments for O.A. There would be more benefit potential for stem cell treatments for those patients that don't have severe O.A. (bone-on-bone). It comes down to triggering chondrocyte cell formation (cartilage cells) from stem cell injections. The goal is to repair focal zones of chondromalacia (thinning of cartilage) within the joint. Patients with moderate O.A. (a precursor to severe O.A.) is an example.