other shorts/competitors. Despite your predictions of doom and gloom on the FDA front and MDXG's ability to sell its products, you continue to be wrong on every prediction since your infamous call that you were shorting the stock at $4. The REGROW Act will be "just what the doctor ordered" for MDXG. Bill introduced in March and has bipartisan support, a rarity these days. From Needham today
INVESTMENT HIGHLIGHTS: The proposed REGROW Act would create a conditional approval pathway for 351 HCT/P products (more than minimally manipulated and/ or non-homologous use). This could allow MDXG to begin promoting its micronized products again (potentially driving upside to revenue estimates) as well as launch other new products more quickly prior to filing Biologics License Applications (BLAs). And it should have no effect on its amniotic membrane products which MDXG. o products that are 351 HCT/Ps (more than minimally manipulated and/or ■ non-homologous use) as opposed to 361 HCT/Ps (minimally manipulated and homologous use). The REGROW Act would allow the FDA to grant a five year conditional approval of products that demonstrate preliminary evidence of safety and reasonable expectation of effectiveness subject to the following: the cells/tissues 1) are human, 2) do not cause an immunogenic response, 3) are not genetically modified, 4) are produced for a specific indication,
5) produced exclusively for a use that performs a similar function as in the donor, and 6) the sponsor provides annual reports and adverse events and submits within five years.
Proposed legislation would change FDA regulation of human cells tissue, or cellular and tissue-based products (HCT/Ps). The "Reliable and Effective ■ Growth for Regenerative Health Options that Improve Wellness" or REGROW Act has bipartisan support in both the House and Senate. The House version (H.R. 4762) was introduced by Mike Coffman (R-CO), Mark Takai (D-HI) and H Morgan Griffith (R-VA).
Washington, D.C. – The Bipartisan Policy Center issued the following statement by Janet Marchibroda, director of BPC’s health innovation initiative, regarding the bipartisan, bicameral introduction of the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act of 2016 (S. 2689 / H.R. 4762).
“BPC commends Sens. Mark Kirk (R-IL), Joe Manchin (D-WV), Susan Collins (R-ME) and Reps. Mike Coffman (R-CO), Mark Takai (D-HI), and Morgan Griffith (R-VA) for their collaboration and introduction of the REGROW Act.
“Regenerative cell therapy—which involves the use of cells to restore healthy organ and tissue function—represents one of the most promising areas for the next generation of groundbreaking treatments. The REGROW Act—which aligns with recommendations included in BPC’s recent report—Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans—modernizes FDA’s current regulatory approach toward safe and effective cell therapies, while protecting approval pathways under sections 351 and 361 of the Public Health Service Act.
“Europe and Japan have outpaced the United States in modernizing their policies to grant patient access to safe cell therapies. As a result, patients are forced to seek treatment overseas and U.S. companies are increasingly making investments in other parts of the world.
“The United States has a strategic and scientific imperative to regain its leadership in this area. We commend the bipartisan cooperation and leadership on this important legislation which will pave the way for scientific advances in cardiology, neurology, oncology, ophthalmology, and orthopedics, and promising new approaches for addressing those with Alzheimer’s disease, Parkinson’s disease, diabetes, and cancer.”
from Brean Capital.
We think there is a good chance MDXG will pre-report 1Q16 earnings next week, prior to presenting at a competitor meeting on Tuesday - as this is typical practice of management. We are projecting revenues up 41% to $57.4 million (slightly ahead of consensus) and EPS of $0.07 (in line with consensus). This is the upper end of revenue guidance $55.5-$58 million. For the year, the company is guiding revenues to $260-270 million--42% growth (34% excluding Stability Biologics) to $266.3 million versus consensus of $264.6 million. This includes $15 million contribution from the Stability Biologics acquisitions ($2-3 million of which we assume will show up in the 1Q, though it’s unclear, whether the pre-release will break this out). This also assumes Wound Care growth of 30% and Surgical growth of 70%. Reiterate Buy and $12 target price.
FDA update: The April public hearing on the regulation of Human Cells, Tissues or Cellular or Tissue-based products (HCT/Ps) regarding section 361, was cancelled due to “High Interest.” This will be rescheduled for later in the year. This also corresponded to a change in leadership at the FDA. Dr Robert Califf took over as head of the agency on March 1st and is considered more industry friendly than the outgoing Commissioner. The following week, the FDA proposed collecting safety data on HCT/Ps, and our assumption is the FDA will not look to make a further move until this data is collected. We also believe that amniotic tissue does not pose a safety risk, and this likely mitigates the potential for up-regulation (see our January 5th note on this topic "FDA Up-Regulation of V. Mesh, Provides Some Framework for Amniotic Tissue"). We expect more comments from management on this topic during the earnings call later this month.
Cover! Cover! Cover!
if you knew the company, which you don't, you would know that Q1 compared to Q4 is always the slowest quarter over quarter growth since Q1 is always the weakest and !4 the strongest. Thats why you informed investors compare same quarter to same quarter.
Yeah you made money shorting it at 6 when you said you were shorting it down to 3 when it it double digits instead. LOL
make up fake data for trials too? This company appears to have a serious problem with key execs. It's a regular revolving door!
LOL! Another great call by Ozark. He sure knows the company! A real insight into whats going on there
tech fans usual "fun with numbers." He forgets that MDXG also has the right and does in fact sell direct to the US Government now in addition to using Avkare. I see $2,624,074 for MDXG/Avkare. 1,332,875/2,624,074 gets you 50.79% NOT 62.74% so from 61.9% in 2015 and trending in 2016 to 50.79%, i.e. down. So sorry to bust your bubble
Nothing works out well for Christian including his MDXG short. He'll learn..someday perhaps