THEY ARE GONNA NEED THAT CASH TO FEND OFF THE LAWYERS - THINK ABOUT THE FOLLOWING
"The FDA warning letter is dated Sept. 26 but Osiris withheld the information from investors until today."
yes however they are going to need it to pay off all the lawyers that will crawl up this companies a@#
To think OSIR got this FDA letter LAST MONTH and WITHHELD it from shareholders ... can you say penny stock??
Think I'm going to short some right now
COLUMBIA, Md. (TheStreet) -- The U.S. Food and Drug Administration has told Osiris Therapeutics ( (OSIR_)) to stop making unproven medical claims about its Grafix "stem cell" band-aid healing diabetic foot ulcers, according to a warning letter sent to the company last month.
The FDA warning letter is dated Sept. 26 but Osiris withheld the information from investors until today.
Grafix is not an FDA-approved drug or medical device. Grafix is a bandage embedded with unmodified and uncultured cellular tissue derived from human placentas and other growth factors. As such, Osiris believed Grafix fit under the FDA's definition of a human cells, tissue and cellular and tissue-based product, or HCT/P, which means it could be sold without regulatory review as a drug or medical device.
In its warning letter, however, FDA told Osiris that two of its products -- Ovation and Grafix -- violate rules governing HCT/IP products.
Osiris must now submit Grafix for FDA approval, just like any other drug or biologic product.
Hey Cimc ... how's that turd of yours doing this morning??????????
I smell dilution coming to raise all the money they will need to run these trials not to mention their lack of approval as it relates to the foot ulcer issue
02:21 PM EDT, 10/16/2013 (MT Newswires) -- MiMedx Group Inc. (MDXG:$4.70,00$0.01,000.21%) , manufacturer of regenerative biomaterial products, said it expects to book revenues of $16.1 million for Q3 2013, which exceeds the high end of its guidance range and the revenue it recorded in the prior-year period.
Furthermore, the company increased the lower end of its 2013 full-year revenue guidance to $57 million, with the upper end of the guidance remaining at $60 million.
6900 ... its not the FDA shareholders should count on it's MDXG management who stated through their own press releases that they will report the moment they heard or know anything material.
Managements reaction will be swift and should be very positive IMO
considering our move today had no associated news one might suspect the price action came in sympathy to the sector. Take a look at the 5 day chart of IBB
I'll say it again this stock is not being traded on the price earnings growth or balance sheet which makes this frustrating
MiMedx Group Receives New Coverage from Analysts at Canaccord Genuity (MDXG)
Posted by Ethan Ryder on Oct 8th, 2013 // No Comments
MiMedx Group logoCanaccord Genuity initiated coverage on shares of MiMedx Group (NASDAQ:MDXG) in a research report sent to investors on Friday morning,The firm issued a buy rating and a $6.00 price target on the stock.
“By our estimates, the dermal substitute segment of the advanced wound care market generated ~$354M of revenues in 2012, growing ~23% per year since 2009. MiMedx utilizes distinct distribution channels for its three revenue reporting segments: Wound Care, Surgical & Sports Medicine, and Other/OEM. We believe the increasing number of reps in the direct channel on the commercial side for wound care, combined with improved coverage, will drive top-line growth in 2013 and beyond. AWC Direct reps are expected to increase to ~140 by YE15 from ~49 in Q2/13.,” the firm’s analyst wrote.
OSIR gets upgraded on the 2nd and jumps 14% then rises again today 5% on no news.
MDXG ha a real product that they can monetize - gets initiated with a BUY (which no one can find the write up) and we barley move
This is weak and the company could use that PR firm they hired many moons ago to get this thing recognized.
call it what you want Home .... but OSIR upgrade hits on 10/2 news wires and as such responds:
Analyst Actions: Osiris Therapeutics Spikes 14% on Piper Jaffray Upgrade to Overweight 10/02 02:50 PM
02:50 PM EDT, 10/02/2013 (MT Newswires) -- Stem cell research firm Osiris Therapeutics (OSIR:$18.69,00$0.13,000.70%) has rallied more than 14% after the stock was upgraded to Overweight from Neutral by Piper Jaffray.
The firm maintained its $21 price target.
In July, Osiris reported interim results on Grafix in diabetic foot ulcers (DFU) that met pre-specified stopping rules for overwhelming efficacy (62% complete wound closure vs. 21% on standard therapy).
In their report, Piper stated that they "anticipate these results will facilitate Grafix's reimbursement in DFU, contributing to significant Biosurgery sales growth in 2014 and beyond."
The stock last traded at $19.14, with a 52-week range of $6.55 to $27.40.
Price: 19.14, Change: +2.41, Percent Change: +14.41
shorts are in real trouble here and are MM's are clearly making sure the tape doesn't light up with shares of MDXG going off this am.... this is so big it's ridiculously BIG!
I see these sorts of relationships positioning MDXG for the buy out here sooner than later