You could be right, if they had a CC they would be in a situation that a question might come up that they would not want to discuss. Like a buy-out.
"All FDA approved IV iron products for the treatment of iron deficiency anemia are iron-carbohydrate complexes, and it is the carbohydrate moiety that triggers the anaphylactoid or hypersensitivity reactions, Dr. Gupta said. SFP (= soluble ferric pyrophosphate = Triferic) does not contain carbohydrate, he said, pointing out that not a single anaphylactoid reaction has occurred in patients being given SFP, even after approximately 60,000 human doses administered in clinical trials. With IV iron products, these anaphylactoid reactions do occur, and in one called ferumoxytol (=Feraheme), patients have to remain under observation for at least 30 minutes after administration, leading to significant inconvenience and restrictions as to where the drug can be given."
Yesterday's news is the kill shot: Approval and imminent launch of Rockwell Medical's Triferic - a highly differentiated and disruptive new entry into the CKD market. Many analysts expect Triferic to quickly change the treatment paradigm of iron replacement therapy in dialysis patients. That's due to the unique method of administration of Triferic which is the only iron replacement therapy which can be delivered via the dialysate solution. This creates the potential for dialysis providers to realize significant savings in nursing time and syringes and supplies associated with the separate - and now no longer necessary - administration of IV iron. Health benefits also accompany the use of Triferic since it is slowly infused into the blood from the dialysate during dialysis in a manner which closely resembles the absorption of dietary iron. Data from two large Phase III clinical trials (Cruise-1 and Cruise-2, which enrolled a total of ~600 patients) demonstrated statistically significant achievement of the primary and key secondary endpoints (all relating to important hemoglobin levels) in both trials as well as an excellent safety profile which was comparable to placebo.
A key motivator in the rapid adoption of Triferic will be its impact on reducing the usage of expensive erythropoiesis stimulating agents (ESAs, for example Amgen's EPO) by ~30-37% as demonstrated in a phase II trial. This translates in about $2,000 savings per patient per year. Although FDA did not allow an "ESA sparing claim" in the Triferic label (ODAC wanted a larger trial population), dialysis clinics are among the most economically savvy providers and will track the reduction in ESA usage and associated savings in real time and mandate Triferic uptake.
Rockwell Medical may be a relatively small company, but it has a strong balance sheet and a laser-like focus on CKD with a ~$50 MM revenue business in dialysis solutions. More importantly, it has strong relationships with leading dialysis providers such as DaVita and also executed a distribution agreement with industry leader Baxter in October 2014. That relationship is currently limited to hemodialysis concentrates, but it would be entirely logical to amend it to also cover Triferic. In the meantime, Rockwell won't be shy about promoting Triferic's important features versus Feraheme as AJ Gupta, MD and Chief Scientific Officer of Rockwell recently highlighted in a medical journal:
All FDA approved IV iron products
I wonder how that BoZo lindabakker gets to post all her twitter links ? Look at her messages, she posts twitter links all over the place.
How does yahoo pick and choose what links can be posted?
Haha...I'm a moron ?
Did they tell you that on..........TWITTER.......goofball ?
Hey lindabakker, you sound like a real pro...............but you gotta go someplace else for your stock tips other than........TWITTER !
Takes all kinds I guess.
All the names in the heading were associated in the past, and some still are in the present.
Everybody knows about Ivan Boesky and Michael Milken, or at least SHOULD know of them.
With very minimal research you can see what these #$%$ are, INCLUDING Jim Cramer, and his buddy Jonathon Aschoff (Brean Capital).
It helps to be aware of the wolves in sheepskin.
We can not assume that everybody is aware of his credibility issues.
Something from his past.
"In 2003 – back when journalists still occasionally investigated stories, rather than parroting whatever hedge funds and Wall Street analysts whispered in their ears – The Wall Street Journal won a Pulitzer Prize for a story that nailed Jonathan Aschoff for being a fraud.
According to the Journal, Aschoff often impersonated doctors in order to acquire inside information on the status of drug trials underway at his target companies. A certain Dr. Cunningham, who worked at a cancer center in Dallas, told the Journal that he initially believed that Aschoff was a doctor. But he discovered that he was dealing with a fraud when he mentioned to Aschoff that an experimental treatment had caused some reduction of the “lymphadenopathy.”
“What’s that?” asked Aschoff. He didn’t have a clue, even though “lymphadenopathy” is a common medical term. It means, “swollen lymph nodes.”
And also........Jim Cramer’s Guide to Market Manipulation.
This was with a Youtube video, but now I see they pulled the video, but the articles are still there.
This Brean Capital guy is part of this Jim Cramer fraud gang.
How CNBC allows this guy to be on their show is beyond me, his fraud activities are a well known fact, so they are not oblivious to his antics.
Brean sees FDA rejecting Rockwell's Triferic
Dec 17 2013
Brean is out with a decisively negative note on Rockwell Medical (RMTI), calling Triferic "far from terrific."
Analyst Jonathan Aschoff doesn't mince words in initiating the shares at Sell: "We believe the FDA will reject Triferic due to poor clinical trial design and questionable efficacy."
"CRUISE had a questionable design that we view as unlikely to result in approval," Aschoff says, elaborating. "More than 80% of the patients in all CRUISE arms did not complete the 48-week treatment period, making the primary endpoint evaluation period highly variable."
Price target is $4, representing downside of more than 70% from Monday's close.
For more on the CRUISE trials, see here.
RMTI -7% premarket
Apparently the FDA forgot to get in touch with "Analyst" Jonathon Aschoff on his thinking, to see if he still feels as he did back in ..............December of 2013.
He says "We believe", besides himself I wonder who the "We" is?
"questionable efficacy" ?
The FDA went ahead and approved Triferic ................with "questionable efficacy" ?
January 7, 2014
Rockwell Medical Announces Triferic(TM) PRIME ESA Sparing Study Selected as Best Abstract at 34th Annual Dialysis Conference in Atlanta, GA, February 8-11, 2014
The Street looks at the Street from their rear-view mirror.
Back there someplace is not where RMTI is now.
Like going through a toll booth, okay you've paid your dues now.........now go ahead, take off.
shortsgondown "WHERE IS THE LOVE" ? If there was zero love for RMTI today, with over 9 MILLION shares traded we would have been down 8 dollars, not 8 cents.
You have to remember that ONE MONTH ago RMTI was as low as $8.10, in pre-market today it was as high as $13.49. Swing/Daytraders could not care less about how great a company is, or it's prospects, they are from the video game generation, they want to make a hit.........NOW!
And then simply move on, no attachment whatsoever. They got into RMTI a month ago pretty much expecting very good positive news near term, and all they wanted was that quick fix.
The bigger picture, or brighter horizon is totally meaningless to them.
With the volume traded today, believe me there are lovers of RMTI out there, and now a lot of them are here as of today, and the couldn't care less people moved on to whatever.
Be glad those types for the most part have departed.
"The results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo."
Read it slow, and without moving your lips, as many times as necessary.
They are comparing the "safety" of Triferic to placebo..............NOT the efficacy of Triferic to placebo.
They left out a comma after the word therapy, and the bashers think they are comparing Triferic's efficacy also to placebo.
We are thanking you turd, for the opportunity to buy more at this temporary discounted price.
Keep up the bad work.............you're real good at it.
Longs it's time for us to throw in the towel, bashers as a rule are much more knowledgeable than any old stinking company like Baxter.
We don't give the bashers the credit they deserve.
Rah Rah Sis Boom Bah............go bashers go !
Rockwell Medical announces Triferic prescribing information
Rockwell Medical announced that Triferic is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Triferic is not intended for use in patients receiving peritoneal dialysis and has not been studied in patients receiving home hemodialysis, the company added. The label will state, "Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable." The label does not include ESA sparing, as Brean Capital predicted earlier when reiterating its Sell rating on shares of Rockwell.
cdrucker..........Genuine longs do NOT follow the panic crowd. They understand that stocks FLUCTUATE.
There is an element of panic today, set off by the sell on the news, day trader crowd.
This is NOT unusual at all.
When they are dissipated.......the pressure is off the stock......get it ?
When the stock zigs and zags , if you sell with every zag.....how long do you think you will last ?
You're welcome !
To cdrucker......Those exiting today, are not GENUINE longs...........there is a difference, a BIG difference !
Then the true value will come.
With today's volume they should be washed out pretty soon.
Don't forget that with this kind of action, the weak kneed sheep follow the crowd, so three kinds of people are exiting the stock.
The sell on the news, the day traders, and the weak kneed followers, going , going ......gone.
Better days ahead, no doubt at all.