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Everybody likes that word....
"soon".
"soon" and "patience". All in the eye of the beholder.
LOL......like I mentioned, next month then.
It's only another 30 days. And then another....that's fine.
Berman is delivering, all the late promises are coming to fruition now.
Wait! What! I missed something! I stepped away for a while. What went down? Oh....you meant next month. Scared me there for a minute.
Well, two weeks are here and gone. This is pretty much Mr. Berman's MO. All hyped sales. All hype to keep investors lured in. Once in a great while, the pps value does spike, I've tracked this for a while and have seen it so it's not impossible. Will big things happen in the next week or two? Not so sure and based off past records, not right now or for awhile. I know one thing, I would not have 220 mil in this like one poster claimed. Not in this or any OTC stock. I can not get my head around that one. So, let's hope next week brings good things, all comes to fuition. If not, I too like another investor posted, will move on. I know, I know......my loss. Boo Hoo.
It lured many in, that's for sure. Me included. USRM better have plan B. They won't survive their payroll without money.
It would not be....much of a surprise to me either. FDA is a money monger. In a previous biotech investments, one company I invested in was after a PMA approval (Pre Marketing Approval)for a device. Every time they applied, it was to the tune of $250K! Rejected and another $250K to reapply. Without significant backing in short order, it was tough to stay alive and they died. USRM could be calling the FDA's card here. in other words, USRM said, no, we're not reapplying. Here's our documents, our proof and all we can afford. FDA could say adios. Or, they could come back and say, ok, we'll how about a compromise, here you go with the approval under the stated conditions. I saw this condition on another biotech, pharma company. They got the word they were denied and then over the weekend, the FDA changed their minds. But... this RMAT is new to me. I'll be honest, I tried to get out today, but would not sell my soul at these prices.
You can't be serious! You put that much into this? The reason US Stem is in OTC stocks was their only way to financially stay alive. Mr. Tomas has known for sometime what this out come was, he just didn't know when to let shareholders know. But, this FDA thing, is a first for me, to hide behind that RMAT approval was inevitablel. He's one slick CEO. Certainly, he enjoys his lifestyle for sure at all shareholders support. I'm just disappointed in Ms.Comella's support in all this misrepresentation on all this. She was the anchor, the glue to all of this excitement and she knew. At least now, we all know know. This is long way off from a profitable investment. That's all I wanted, to have the facts and decide. This 60 days more, 60 days more, 60 days more, etc. got exhausting. Enough! GLTA.
Read my post Zues! Post #299664 and Hippo posted it. At the latest my dates are correct and giving the benefit of the doubt to FDA's response time frame.
No, this is not new science by today's technology. And if there were a stem cell provider worthy of FDA approval with great scientists and results, it's this one! Good things do come to those that wait, until the excessive waiting becomes being conned for someone else's greedy gains. Hang there. I'm not. Enjoy.
And I believer her too. Her credibility is as good as it gets. But if supposedly the "word" has not been given at this point, beyond the 60 days or soon then as an investors, one must choose if it's time to move on. If as an investor with all this positive accomplishments, and this has not changed in two weeks. Well, common sense has to kick in. GLTYA!
Yes, the response will come from the OTAT on the RMAT submittal. That's the Office of Tissue $ Advanced Therapies where the RMAT is submitted. Applied for on Jan 31, 2017. 60 days takes them to mid March, OTAT wants a little more info and it's reported the request was minimal and immediately provided. On May 31st Mr. Tomas blogs........"in May, the FDA acknowledged that they received our additional information and are still in the process of reviewing our application for RMAT. Please note the FDA takes up to 60 days to review information submitted. That takes them to May 30th from the March submittal. Give them a 3 day grace period and we are at buzzer time on June 2nd. Here they are, June 13th. Given the great PR's, Ms. Comella's reputation with stem cell research and the FDA, this delay isn't making any sense. FDA is way over due. I'm beginning to wonder. I really, really thought this had great promise but wonder now. FDA is by what I read, 11 days late. Or are they?
It is in deed. And if the FDA is "uncomfortable" with this stem cell research, one has to wonder to the lobbyists influence. Watch the movie, "living proof". True story on caner drug, Herceptin. Was rejected for years by FDA until one of the board member wife needed it. Then it got approved like that and it was approved in a blink of an eye. Great movie and makes me SICK at the same time! If he FDA is so corrupt and influenced, fire them all! Put them in orange suits! The age of new drugs, new treatments has been here for some time. New hope, new wonderful treatments. Keep vigil on "Crispr" technology. This is even better. Yes, this week could and should be USRM's day.
I believe you are wrong on that assessment or interpretation. Late march the FDA responded and asked for more information for clarification. It was not much they needed and the information was quickly gathered up and submitted. What Mr.Tomas blog said was in May (and when in May?), the FDA said "we did receive your information" and we are STILL reviewing the information". I got no indication that meant the clock is reset as of May...what ever the date. Ms.(Dr.) Comella said "we are uncertain of timing". Meaning just that, when is the 60 day response clock up? That's my interpretation.
And no question she is accomplished, recognized, respected by FDA, medical research, etc. Great credentials and soon to be Dr. title, and yet nothing for needed approvals for RMAT. What's wrong here? Something. January has turned into March, March has turned into May, now May has turned into July. July will turn into September. Good luck to all of you invested. Something is not right here with such accolades. I'll check back in couple months. I wasn't a big player anyway. Just looked promising.
Sure you did..............
You had too much to drink. This is getting way too crazy.
Most informative, very interesting.
So it is Dr. Kristin Comella. Thought so.
And if you go back to around the 23rd of March when the FDA requested additional info, US Stem said it was very little what they requested and the requirements were immediately complied with and sent back that day or the next.
I don' think that's allowed:
"However, once an insider takes undisclosed, or secret, information that he or she has and uses it for monetary gain, then it becomes an illegal activity. And in this instance, an insider is not just a person working directly for that company. It can be a spouse, a relative, a friend, or a colleague."
Possible, as 2 or the last 3 RMAT FDA approvals happened on a Monday. The other was a Tuesday. Possible, but then, every day is.
I'm believing in ya Cdizz123.
So that being said, let's get it out there for all to see. Nothing is moving this miracle wonder. 5 million support, 100 million support, RMAT support, FDA approvals on in the future, Mr.Tomas at 1.2 million/year, Ms. Comella at 750K per year. Got no idea what Dr. Bill gets. Time for shareholders to have a little of the cake. Most important of all, the patients that could use this to save their lives. Don't know what that informative webinar was for. They're preaching to the choir with that.
1
Is the Webinar over?
Well, pre-market news didn't happen. But it is Monday and the day is far from over. Two of the last 3 RMAT approvals happened on Mondays with the 3rd on a Tuesday.
My point is why do they need an additional 60 days on a one or two page amendment to the original 200 page submission?
The FDA already used the full 60 days on the first go around in the January 27th to the March 27th segment. FDA had a some questions of clarification and those limited questions were immediately answered from U.S.Stem.
I think Stem has had their answer from FDA and is staging the right time and date for the announcement. Time is money and every day, every hour counts in profitability.
One just doesn't know. Some intense DD, and go for it, or not.
Yes. Vanda Pharma. Hetlioz, sleeping disorder. It was denied at first and thought dead. Overnight, FDA changed their minds and boom! I only had 35,000, but still, $$$$. Never looked back.
One was a medical device, breast cancer. Was at .30 and going for FDA approval for PMA. Took a week, so it escalated in excitement to $1.91 during the waiting. Then the decision came out, declined. It dropped like a rock and died. The dagger in the business heart. The other was a med at .02. and on "Halt". Took a few days, but got approved and shot to $9.30. I was like, what the ....! This was few years ago. I like Bio stocks, but hard to find a one that comes to fruition. USRM might be. Test the waters.
You could be right. I've been in two other FDA deciding stocks. The impact was .... unbelievable. One, $1.60 per share swing, the other......over $9 per share swing. The FDA panel is overloaded, always has. If there is something, anything of value and convincing, they'll be happy to approve it and move on to the next. If the announcement happens soon, great! If it goes to the end of May and then delay, Bail, run.
Typo, 60.
that would be good.......but without FDA influence,
not much will happen. The application to FDA on the RMAT was filed January 17th if this is true. 50 days is over due.
Now That's a good post! Appreciate the facts and info.
That's what was said last year around this time and then Christmas 2016 was going to be reward time for all longs. Let me check..........nope, that didn't happen.
I'd use that term "trading" loosely.
This is a joke, right?
Well.......the rumor is that Talk will give all us longs a nice holiday reward for our "patience". Isn't that right?
Now....how about those missing filings?
It's September now. Today would be just fine with me.
Have a nice extended weekend to all. Advocates and non-advocates of Talk.
Not sure "holding fast" is correct word.
With reservation and trepidation is more like it.