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I think Tomas was pretty clear.
"Due to the uncertainty of this program, we feel that our shareholders and patients will be better served if we focus our efforts on therapies that benefit patients RIGHT NOW."
I know people might jump on me (remember we are all on the same side here)but I think Tomas has done a good job considering the circumstances.
It's time to move on as Tomas indicated. The political climate is changing.
Hopefully Gottlieb can clear a path.
I am holding all my shares.
I agree. Don't want to overreact here. Now we can focus on the business rather than RMAT. I look forward to your continuing DD.
That's right. It's okay to be disappointed but it looks like Tomas is being practical. I bet the FDA wanted more testing which USRM did not or could not pay for. It's simply too risky because the FDA could still deny. The continued pending RMAT situation was holding this stock hostage imo.
HH I for one REALLY appreciate all your efforts with providing us DD.
The sun will come up tomorrow and like the sun this stock will rise too.
This is the realities of dealing with the FDA. I am not surprised. The blog gives people clarity now. I do not believe USRM has given up obtaining FDA approval. I think they will wait until Gottlieb has had enough time to put his stamp on things internally.
In the meantime they are telling people to focus on the business aspect of USRM, not the whims of the FDA. I am still here to support USRM as an investor. I think they have an incredibly bright future.
Well said.
The only thing I would add is to say that people are flipping because they can for now. USRM is ridiculously undervalued but this will change.
USRM$
Why wait emit?
I have already sent an email to Lamar Alexander. I suggest we all do the same. I simply stated:
"... we are anticipating progress not road blocks. The purpose of RMAT is to facilitate in making available to the public breakthrough treatments. Stem cell therapy represents progress in breakthrough medicine. The FDA needs to assist in facilitating the progress of this new technology that has been proven to be successful in treating serious life threatening diseases like CHF of which over 7 million people in the U.S. currently suffer. In keeping with the spirit of the 21st century Cures Act, I expect, with your oversight, that the FDA will expedite this process."
That is what I am thinking too. I would rather discuss something like this than speculate on dates for FDA decision.
I agree. The broad market has been somewhat bearish lately but that will change as it always does. USRM has shown good support though.
Long USRM$
There are a number of ways to interpret the wording of Tomas' blog. There are unknowns in terms of the actual date the last request for information was sent to the FDA and the date it was officially received. They confirmed receipt of information sometime in May. Does that mean info was sent in May or earlier in late April?
The status of the clock (reset vs. restart) is also in question. For now it's all just speculation which is what Tomas must want. He is intentionally being vague. He must have his reasons.
USRM$
Nice.
I agree.
Good to have you around.
We could use the firepower..lol
USRM
Still holding strong.
Nice to see some new people here.
Keep it up.
Have a nice weekend everyone.
USRM$
Lets have a good day.
USRM$
I feel ya. I am hopeful too but I try to remain grounded. As far as USRM is concerned, as I have said before, I will say it again, the Fed has far more reasons to grant RMAT designation than they do to deny it based on the results of Marvel. Also, we have the US senate behind this tech along with Gottlieb. Just a matter of time.
GLTU and all the other longs out there.
USRM$
I am calmly optimistic that the day is near. No predictions. No disappointment. Lets wait and see.
Noticed that too. I understand the reasoning for a disclaimer but she is not trying to sell anything. She is making a statement. Don't like to speculate but it is curious.
It was both a good day and an interesting day.
Look forward to tomorrow.
USRM$
Exactly. Why go public with Myocell when RMAT is pending?
I know what it meant first time I read it. We Gottlieb this.
Interesting timing for the Ad. It would not make good business sense to promote Myocell now if USRM didn't expect to have RMAT approved.
Looks good if you ask me.
Go USRM$
Hold on to your shares.
USRM$
Awesome. This is important. USRM has for the most part been pretty quite about promoting Myocell, instead focusing on other stem cell related regenerative medicine treatments they offer.
Nice start to the day.
It is an add for Myocell. Great find.
Your kids are smart.
Of course I would not be okay with it.
What the FED decides is out of my control.
I base my decision to hold firm because I believe (based on my research) that the FED has more reasons to approve Myocell than to reject it.
"Just saying "if". I rather make a profit and get back in soon thereafter"
If investing was as simple as waiting for good news before jumping in everyone would be rich. You need money to make money and you can't have money locked up in something else when news breaks.
Whatever you decide,
GLTU
Yep and I'm one of them.
I don't think waiting for RMAT or waiting for a buyout or waiting for the next quarterly is a bad thing. 2 of the 3 will happen (RMAT/quarterly) and they will effect the s/p either positively or negatively. Time will tell.
GLTU
Lets go. Ignore the noise.
USRM$
Yep. Holding tight. Q2 should look good. Wouldn't mind RMAT designation sometime this month, then positive Q2 in August followed by buyout. But B/O may come much sooner. We'll see what happens.
True. USRM doesn't get the attention it deserves, but that is changing fast.
USRM$
USRM$$$$
"USRM this stock is the real deal.. going long this time around. Just wanted more shares"
Oh really?
You're right USRM is the real deal.
Have a great day.
No dip today. No dip to be found anywhere. Must be hiding under a rock.
USRM$
It's the scent of green tea...$
We all need to be patient.
Lets not get ahead of ourselves.
OK.
Don't let emotions steer the ship.
GLTU.
Sounds reasonable.
I've bought my fair share since January.
Nothing left to do but keep holding until a decision.
Niceee.
Lest go USRM$
oooh..:)
Shadow says hi again to Bow tie.
USRM$
Who is this Gottlieb guy anyways.
Never heard of him..:)
USRM$
Nice post emit.
USRM$