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I don't understand. It makes no sense to me. Please elaborate.
USRM$
People can say what they want but the fins will say it all.
Arrayit Corporation @arrayit 22h
22 hours ago
Arrayit schedules final conference call with top accountants RRBB Somerset NJ to complete our public company audit www.rrbb.com
https://twitter.com/arrayit
Nah they didn't let you in. "No-shoes-no-service" bob-barefoot.
ESO$
That is fantastic. Glad we're on the same team. Thanks again.
Lets focus on the audit completion first. Take over talk is far to speculative and down right silly at this point. Completion of the audit is the first step along with removal of the stop sign. Everything else will take care of itself once ARYC becomes current. I have loaded up big time at this point.
Q2 is coming. RMAT announcement is coming imo.
Thanks. I believe you. I appreciate your efforts. It would be nice to see ECOS headquarters when convenient.
ECO$
Plenty of juice left in the cylinder. Just needed a little purging before Q2.
USRM N20 baby.
How much are you buying?
Oh yeah. Finally. I am happy for the longs here.
Yes. Competition is out there. The early bird gets the worm.
USRM$
Please understand it's not just Tomas.. The BOD has plenty of influence on what he does or says imo.
Exactly.
"What would they do with it if they didn't pursue it?"
Because they completed phase I/II and a portion of phase III trails there is value in their R/D investment in terms of qualifying under new Texas legislation. I expect other states will follow the lead of Texas.
I hear you..
But I need confirmation they intend on reestablishing contact with the FDA now that guidelines will be released in Sept. I am expecting that to be the case, but that is only an assumption. I don't trust assumptions. Tomas needs to confirm this for me to believe they are actively pursuing RMAT once again.
Sounds great but the FDA won't/can't approve if we are not in the game. I can't imagine a more opportune time to obtain approval. Hopefully Tomas and the BOD's agree.
Nice.
ECO$
Based on your opinion I bought more today. Keep up the great work
ECOS turning pooh into cash.
Thanks pooh.
"Quote LOL NO"
Correct.
Better pick up some cheapies too.
I bought more today just because I like French toast.
Another 50,000 shares today.
Thank you shorts.
At this point it would be self destructive for ARYC to claim an audit was taking place when it really isn't especially when naming the auditor that is carrying out the audit. Way too much to lose for both parties here. The liability is too great to ignore. I think we are okay here. I am buying more.
You might be right.
Looks like you got your answer in terms of range. I think it's coming end of month. USRM needs a pop and that'll do it.
Sounds about right.
Nice.
Remember Q2 coming soon.
Picking up a few more cheapies tomorrow AM. Nice buying opportunity here.
I like French toast and USRM$
"Not much to see here today...."
Yes lol.
Lets go.
How are they to serve the needs of the population? That is like saying state and local public services are free now. No need to pay taxes to support them in the future. There are costs associated with providing medical services that the goodness of our hearts does not pay for.
No medical institution can afford to provide services for free without revenue stream, especially on a large scale. Non profit hospitals still charge for services (I worked at one for many years). Even hospitals like Shriners' rely on revenue stream from donations and other sources. No biotech company can exist without revenue from their products.
This is just for show. They are trying to appease special interest opposed to this bill. It is an example of ignorance by government. Just as pigs can't fly, that provision will be changed.
I agree. I am hopeful too.
Shadow say hi.
Stem cells shouldn't be considered a drug imo. The use of adult stem cells for re-implantation should be considered as autologous like any other native tissue re-implantation or autologous blood donation. Stem cells are not synthesized from chemicals like a drug.
Stem cells can be manipulated via the introduction of an adenovirus vector which introduces proteins that act like a beacon for the propagation and differentiation of other stem cells (or myoblasts) in the case of muscle to the affected area.
The FDA needs to come up with another designation that does not classify stem cells as being a drug. The new classification should include guidelines that are specific to the nature of genetically modified autologous tissue/cells NOT drugs.
An interesting read:
http://www.lifenews.com/2012/08/01/why-dont-patients-stay-in-the-u-s-for-stem-cell-treatments/
An example of FDA ignorance:
"What the FDA said is what Celltex does to the stem cells is more than 'minimally manipulated,' which means that when they put the stem cells in that medium, they're doing something to it, and that process needs to be regulated," she tells Sullivan."
http://www.npr.org/2013/02/02/170942324/fda-challenges-stem-cell-companies-as-patients-run-out-of-time
http://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117
Might want to rethink that one.
GLTU
I like that.
Tomas,
"...we feel that our shareholders and patients will be better served if we focus our efforts on therapies that benefit patients RIGHT NOW."
I think they can and should be pursuing both RMAT and revenues now that guidelines will be released in Sept. Because the playing filed is shifting quickly, USRM needs to be nimble like any other opportunistic business. The money they invested into MyoCell was a means to an end, correct?
JMO
Yes.
FDA guidance is set. Will be released Sept thanks to Gottlieb. No reason not to pursue RMAT as FDA approval matters greatly. FDA application fees are a cost of doing business like it or not. Revenues can be pursued concurrently. FDA approval = legitimacy in the eyes of the public, insurance companies, and the investment community imo.
USRM$
I agree. Just when the sky looked like it was falling. Lots of lessons to be learned. The longs seem to have control here.
Much more $$$ yet to come.
"Gottlieb once stated that he doesn't believe we should regulate this type of stem cell therapy at all."
Exactly. It's like in my past life in orthopaedics. We harvested grafts from the patient all the time (autologous). It is not a foreign body implant. We are implanting the patients own tissue. In the case of stem cells that are engineered post harvest - they are simply maximized to induced more propagation of stem cells that differentiate into native tissue cells.