Didn't like my $26.50 call. Tried to tell you. Giggle Giggle
Ta Bonkenx. If it costs money to cover Short Sales how could the dude who said this have come away with extra money for new bios as well?
I was a long in March and then in May a short in July and I have doubled my money this year. My reason to cover and take a 8% loss was to use that money which has been dead money for 2 very promising bios.
I wish there was an ETF that followed all the Baker Brothers stocks because those guys are winners. Owning 45% of this company? Crazy awesome. They don't make mistakes.
Float 16 M shares BB14+FMR 2=16 m
BOD(6 members) all delivered small amounts of shares spending money for a few months as the stock lays dead in the water?
Unfortunately Yahoo no longer allows the link to be posted.
Note that the biopsy samples in this study were all from radical prostatectomies. This may underscore the GHDX test being sensitive to sample volume and heterogeneity effects.
Myriad Genetics Publishes Prolaris(R) Data in the Journal of Urology
Tue February 18, 2014 7:05 AM|GlobeNewswire | About: MYGN
SALT LAKE CITY, Feb. 18, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) today announced it has published data in the Journal of Urology demonstrating that its Prolaris test accurately predicted, based on biopsy specimens, which men would develop biochemical recurrence (BCR) or metastatic disease following radical prostate surgery. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in more than 5,000 patients across 11 clinical studies.
The study evaluated biopsy specimens in 582 men who were treated by radical prostatectomy. In the study, biopsy samples were evaluated from three cohorts of contemporary patients in the United States and Germany. The clinical endpoints were metastatic disease and BCR. In all cohorts, the Prolaris test was a statistically significant predictor of BCR and was the single strongest predictor of metastatic disease when compared to Gleason Score or PSA. In the pooled analysis, each one-unit increase in the Prolaris score translated into a fivefold increased risk of metastases and a 1.6-times increased risk of BCR.
While the FDA has done some things in recent years to improve how it reviews companion diagnostics that help guide treatments for cancer, there is still a vast swath of the diagnostics world that is lightly regulated at best. It allows for skepticism about these tests to fester among payers, and spawns fear among investors who worry the payers will never pay. “We’d like a process that has clarity and some certainty around how you do it,” Popovits says. “When you develop a drug, you go through Phase I, II, and III, and then you go to FDA. They say ‘yea or nay,’ and then you get reimbursed. That’s a process we need.”
For sure, the idea of tough, consistent FDA regulation of diagnostics isn’t new. The FDA has been making noises for years about getting more aggressive about regulating “high-risk” laboratory-developed tests (LDTs) that influence big healthcare decisions like how to treat a cancer patient—where the consequences of a false test can be dire. AdvaMed, the trade group for medical device and diagnostic companies, has said the FDA should regulate “higher-risk” tests. Industry leaders Brook Byers of Kleiner Perkins Caufield & Byers and Mara Aspinall of Roche’s Ventana Medical Systems unit co-wrote an op-ed for the Boston Globe in 2011 about why they think the FDA should bring more rigorous regulation to the diagnostics business.
“For one thing, both payers and physicians need and deserve to have confidence that the advanced diagnostic methods being used are reliable and accurate,” Byers and Aspinall wrote. “As it stands today, diagnostics are regulated by a variety of state and federal agencies, but there are, as yet, no clear policies in place for the approval of new molecular diagnostics.”
Some of the more exciting ideas in biotech are coming up in molecular diagnostics. There’s cool science at work. A number of tests have potential to cut down on overtreatment, reduce waste in healthcare, and give physicians clever new ideas on how to help patients.
But this industry, which accounts for less than 2 percent of healthcare spending, is stuck in neutral. If it’s ever going to grow into a bigger business that delivers lots of valuable information about health, the molecular diagnostics industry needs a tough, science-minded, credible regulator. It needs a thorough, predictable, and efficient third party who can comb through complex data sets and say with confidence what’s real, what’s clinically meaningful, and what’s BS.
Physicians, patients, and payers aren’t just going to do this by themselves.
Just like the pharmaceutical industry, the diagnostics world needs a strong FDA.
“We have to have some kind of pathway that gets rid of the uncertainty hanging over the whole space now,” says Kim Popovits, CEO of Redwood City, CA-based Genomic Health (NASDAQ: GHDX), a leader in molecular diagnostics.Kim Popovits, CEO of Genomic Health
competition is real,always has been.No one knows the numbers until they are out...and the number stunk and thus the sell off....tried to tell you terry. Giggle Giggle
Wash, rinse, repeat! In wash mode now. target $32 then entering rinse mode. Giggle Giggle