watching..
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look at how clouds clearing out in an area $USRM has always been advocating..
https://www.cnbcafrica.com/2022/how-there-could-finally-be-a-cure-for-diabetes/
USRM should dig patent space a bit and invest in defending any patents they have!
yes “billion”.. what would’ve been this company’s true eval, even to conservative estimates! btw, thanks to those pointing that “flag” out ??
thanks! i defer the finer details to subject matter experts on this board like you and others!
it’s good science and i’m USRM long!
in my layman (non medical, legal) terms
#1
FDA sues USRM stem cell procedure is illegal as the extraction of cells qualify it as drug, so get approval by proving safety first
#2
FL court sided with FDA as we know and bans USRM.
may be partly ‘cus USRM has presented conflicting arguments by saying “same day” on one end to show it comparable to other bone marrow procedures etc while also saying it’s safe as we have done so many procedures and see patients banked their stem cells with trust. well “banked” one imply your intent was to use them at a later day or might even use in other patients too?
#3
USRM can only argue it’s not a “drug” so FDA doesn’t have authority but they just need to comply with medical boards and prove it’s safety.. and continue. stick to its “autologous” nature of its business and safety track and FDA can’t argue ‘cus you’d have no authority on that subject. FDA position is weak on double standard here..
recent development to isolate the stem cell banking issue from core case may be indicative that defense is now clearer about how theirs is same as current marrow/transfusion procedures. FDA may recognize overstepping and try to settle by a compromise than appearing like a total failure so let USRM with their “analogous same day procedures” with a guidance to get their approval for other use cases? just guidance is not legally mandatory.. just like RMAT etc! and differences in court perceptions in CA, FL cases may have resulted due to the nature of defense.. IMO that cross learning is key! if you agree to “drug” definition, you already lost the argument.. just focus on that aspect and your business is safe until some national level legislation is defined!
(apologies for poor use of English)
same here.. held most since 2016-17.. averaged down a bit near sub pennies but now into some green! some solid accumulation going on these last few months.. hoping for great outcome both for longs n patient populations.
“US Stem Cell INC and US Stem Cell Clinic will continue to operate business as usual”
“the FDA will strive to work with the industry to establish clarity around life-saving innovations in regenerative medicine."
this judgement gives a small “win” that FDA badly needed these days .. but in big picture it would be interesting to know what this KC’s “business as usual” line means! is it possible, USRM may’ve negotiated some favorable terms in an immediate leg up for their yrs of research work as it obviously working with undisputed success rate! all the argument was around it’s “drug” or not and if yes, there needs to be an approval.. so an edge there is all they need and it’s all be fully legit and widely accepted! just a speculation..
‘m not an expert myself.. but OTC order execution is not matched on a order book.. and hence the targets of money makers MM manipulation
https://www.investopedia.com/ask/answers/buy-over-the-counter-stock/
others may chime in
proprietary protocols shared? patient personal records from clinical studies shared? etc.
breakthrough: wet AMD treated (actually eyesight restored!!) with embryonic stem cells in UK!
https://www.google.com/amp/s/globalnews.ca/news/4094737/age-related-macular-degeneration-stem-cell-treatment/amp/
USRM blind ladies case with possibly a dry AMD seemed a little too early for them and given up for bad repo but see scientists find success with wet form! no denying that stem cells have great potential and come of age.. I believe all longs are well positioned with this!
this is exactly what they should have done long time ago going all offensive instead of wasting all this time..
‘m not a financials guy but could someone shed light on how does member percentage raise to 49.9 without add. consideration? just by plain reorg! and that number clearly limits to non-controlling share, which is very typical in foreign investments space. any speculations on partnership/expansion deals?
well said
the significance of this development is that it proves the “criminal” element is out of USRM case and it’s just a matter of negotiation and the very basis for mediation!
heard constantly “processing with enzyme” was the issue but then same FDA accepts an IND on those lines! could it be that the real contention between FDA and USRM that one asks for a full reset and start from zero giving up their years of studies and the other says we are ready for final approval! the defense would argue saying the “drug” definition wasn’t clear then so move on!
Correction: Read “Penn State” as “Penn Scientists” (from Penn Medical Center @ University of Pennsylvania)
CAR-T cell therapy technology from Penn State licensed to Novartis and that resulted later in first ever FDA approval of Kymriah in Aug 2017. It’s list price is $475,000.. (Ref: https://medcitynews.com/2018/10/novartis-car-t-likely-improves-log-term-survival-and-is-cost-effective-study-finds/)
USRM has to substantiate their claims with studies and trial data and they will make the cut. If they have substance I’m sure will be a great take over target. This FDA case is all drama by high stake players but the flip side is it can be good test for USRM to validate their claims. If they succeed, o’boy..o’boy.. sky is the limit ??
CAR-T cell therapy:
see the supposed “drug” safety after going thru all the “fool proof” trials and systematic study of long term adverse events etc..
check here the mainstream BP medications (ACEI class) and cancer..
https://www.ajc.com/news/world/this-common-blood-pressure-medication-linked-greater-lung-cancer-risk-study-says/RDuo2ICyhpNEo35AdK5CiJ/amp.html
Basic science studies solving the mysteries! What USRM sees in practice is being proven slowly and steadily..
Bioengineers borrow from electronics industry to get stem cells to shape up
https://m.phys.org/news/2018-08-bioengineers-electronics-industry-stem-cells.html
wow! keeping USRM alongside top biotechs, biopharmas do speak volumes! .. not if but when it blasts off!
IMHO, stem cell tech appears to be very disrupting and hence the resistance USRM faces, people in medical field are fully aware of it and FDA currently seems not having any legal jurisdiction to regulate this particular flavor (homologous adipose) as it pretty much questions the term “drug” and how it applies to it instead their contention is it falls into minimally invasive same day “medical procedure” and need not have to go thru usual approvals , even RMAT, as of today.
i also think if their(USRM’s) procedure doesn’t work or FDA believes it a sham/shady company wouldn’t FDA cease its operations straight? it’s warning letters are indeed such attempt but then realized they just can’t redefine/reinterpret but only merely enforce congressional mandate in the form of law! and I also feel this as a last ditch attempt now so 1) they wouldn’t look bad in public eye as it shows their proactive effort while this sector flourish 2) wouldn’t look bad (or being protective of this stem cell field) to senate/congressional committees and any related pressure 3) now this draws all public attention, causing stir and debate and now lawmakers take serious note of it and either pass new laws to allow a different policy framework for stem cells or amend existing law to expand scope of FDA jurisdiction. either way it’s all positive outcome for FDA so common sense why not do it? so in essence it’s a strategic move!! and most importantly if bigpharma or whoever special interest is allegedly behind this negative campaign and vicious attacks, they win in this too as it finally clears out air and in the end if public rallies behind this tech (worse case for them) all this brings legitimacy to it so they can chase front runners and buy them big time. i think the key is the truth of the effectiveness of this tech and genuine patient testimonials that define its future course!
coming to the bright spot (s) for USRM is they are one of the key players now, they claimed time and again that stuff works and many patients treated and healed, FDA's direct law suit now actually reaffirmed their place as leading crowd, and since its a long process and could take years they continue sell their kits and make big bucks while continue defending their position etc. honestly i think this goes business as usual pretty soon and it’s even better for us longs and believers too! i’m sure questioning KC’s scientific expertise and/or her academic credentials, relentlessly bringing up blind ladies suit, claims of dilution of stock etc all plain noise IMHO so we are better off just ignoring it and not even respond!
all in my opinion and i’m a long here so good luck to you if you are one too!!
“ a wiseman never knows all. only a fool knows everything. “
it’s certainly a great sign plus they chose to do this with 4 yr vesting schedule to instill trust, confidence and most importantly to demonstrate the leadership’s long term commitment in this fast emerging field! good call by Mgt.
Post Views:1500+
in 3 days and counting..
saying about the bullish report we saw this week..
https://oracledispatch.com/2018/04/03/theres-potential-breakout-us-stem-cell-inc-otcmktsusrm/
paid members, pl check with admins on why NEWS section eagerly sticks this latest piece but never had any of those positive PRs for months? i don't worry about company blogs but many PRs hit public space for sure then people can relate to what sort of hike in sp this time.!!
Post sticky worth
7 mil people just in US alone? just capture 1% and it's few multiples to current mkt cap. $$$
mkt cap is close but aren't revenues for just 9 mo. exceeding 4 m? and last qtr itself was 1.5 m and there was 40-60% growth q over q.. to any account the annual rev seems upwards of 6 m.
a full week of gains in pps and already sowing seeds of gloom!! it's the same crowd of LOL.. all know for what? good luck trying and bringing more attention along the way ??
strange there was no buzz here from this as it room place jan 22-26
http://www.worldstemcellsummit.com
any thoughts?
president Trump brought up Right To Try (RTT) in his speech at House and Senate Republican Member Conference and quoted FDA chief ..
why 2020?.. thats too late.. can be 2018.. or even tomorrow.
big moment can be as soon as big pharma wakes up and rush to acquire small mkt leaders!
Not sure if $USRM is into this but stem cells use for root canal, check this out
http://bigthink.com/news/say-goodbye-and-good-riddance-to-root-canals-it-might-just-happen-heres-how
Interesting times...
An interesting article on stem cells and regeneration of tissue:
https://futurism.com/scientists-discover-way-prevent-stem-cell-loss-improve-tissue-regeneration/
"International Society for Stem Cell research who wrote a letter to lawmakers over the summer, ..."
does it seem really advocating stem cell therapies? just think of is the sussess rate for big pharma drugs in late clinical trials n how is this any different!! folks either want to slow it down OR seeving self interest by squeezing in established hospitals/facilities in the way!
well perhaps fda picked this company for fight leaving the rest for a reason? 'cus this is not one of those fly overnight shady clinics..BUT one with basic scientific research backing their protocols, products n one not easy to budge for biased warnings etc. ofcourse all IMHO.
To be fair sticky this post as well as a post with a link to the original FDA warning letter so visitors can form their opinions. Right?
Worth a Sticky?
it's a growing business, and importantly with patients out of pocket dollars, doesn't it tell something? FDA really needs to get it's act together fast to establish guidelines n document what each type of approval really means in commercial use. blanket closure of all seems not an option at this stage after allowing this far.. only regulating guidelines with enforcement is the only option IMHO, so leading companies like $USRM succeeding is not an if but when.
so leaving it to people's imagination the scale of money flowing, revenues with FDA approved procedures n insurance covering them.
just added 100k but strangely an ask slap limit order took 12 min to fill (12.44 to 12.56 EDT) via Fidelity. appears as if someone consiously filling orders in a controlled manner to me..never saw this before. don't even know if its feasible, anyone daytrading know better I hope. pl comment if you are open to constructive dialogue.
Nice post justifying why USRM is tight-lipped on this. AA would be gr8 indeed !!
It me on who is playing to keep price pegged to that 0.08 - 0.10 tight range. The speculation should push it a lot higher with all positive indications. Recent investor paying close to 0.08 for up to 5 mil, does it hv any bearing why it hovers around that baseline all the time? Can one go to MMs and buy what all they want in secondary market? I'm not a seasoned investor myself but just hypothetical thinking. However I'm long n held shares since for many years with hopes that stem cell could hold keys to future and disrupt treatment options for human kind.
GLT all longs!
Pl count me in too for a CAL.
Would like to see what the supporters have to say who went beyond to vouch for CEO's integrity, cost conscious, and character etc. Lost a grand on this! Its a pity that even SEC filed stuff can't be trusted these days..and avg investors are screwed.