Jeffries weighs in on 4K decision -_-

Not final until 11/20/16, but looks like it would be an uphill battle. I can't image Opko having something up their sleeve. Glad we have other irons in the fire b/c looking like 4k score is going to be a dud. Urologists just are not using it and without reimbursement, that will not change.

In the scheme of the overall pipeline of OPKO. The 4K diagnostic test will ultimately not be the giant driver of value. When a non profitable company begins to launch any products the marketplace looks for acceptance but the reality is the other drugs in the pipeline some very close to fruition will dwarf 4K in financial performance. Also noted was the Jefferies analyst that broke the so-called bad news. Jeffrey's much like the former bear Stearns caters to the short element that have a giant bet placed on opk don't think their neutral rating and down downplaying all things important with opk is by accident. It's short manipulation

"His reply x3 was PHI."

Let me be the first to say I don't get that.

I get that he is now doing 4K, but what the hell does " His reply x3 was PHI" mean?

As for competition, or perceived competition, from my POV, it only indicates there is a market worth something. No capitalist would bother otherwise.

A piece of a pie is better than no pie at all. And technologistcal superiority is not necessarily supremacy in a given market.

For instance, Beta-Max was a superior technology in it's time. But VHS took the field.

Not sure what I am getting at here, other than to say "logic" frequently has no place in markets.

That said, posting after watching the 2nd Prez "debate" and after "compensating" for having to do so might not be a good idea.

On the subject of debates, may I offer an observation?

Back in the day, a debate was a two-sided conversation. One side was pro something, the other side (surprise warning) was anti something. Same something in any case. That was a debate.

What passes for a debate these days is....well....it is........it is..........BS.

Not sure what it is, not sure what, if anything, I give a good poopshit (wonder if I got around the censor with that artful dodge)  to call it. It's all kabuki theater.

If the purpose is to sway opinion from one camp to the other, none of this BS makes a mote of difference.

If they ever, and they meaning the entertainment crew who hosts these ridiculous escapades, get around to do a serious debate on and of a topic or two that actually matter to real people, then wake me up. Or don't. I already know where my vote, my wife's vote, and the votes of the gaggle of old ladies who play illegal games of chance with her, are going. And it ain't for Killary.

JMO on Palmetto, Novitas (and other MACs (Medicare administrative contractors) and the 4K Score test.

1) Usually the local MAC (Novitas for the 4K Score test) decides on Medicare reimbursement for companies in its' service area. Thus Novitas has finally say on medicare reimbursement for the 4K score test.

2) Palmetto has carved out a recognized expertise (accepted by other MAC's) in the complex molecular diagnostic services area. Other MAC defer to Palmetto in this area because of it's expertise.

3) The question then becomes is Opko's 4K score test a complex molecular diagnostic test/screen. Opko says it is not. The 4K score test is the combination of 4 simple tests and application of a math algorithm to determine the probability of aggressive prostate cancer in a patient. It is beyond my expertise to have an legit opinion but my best guess is very few would consider this "a complex molecular diagnostic test".

4) Assuming it is not a "complex molecular diagnostic test" then we have a situation where Palmetto is clearly over stepping it's area of expertise and it's actual geographical area. This maybe viewed as a first step in a power play by Palmetto to become the dominant MAC in the country.

5) Assuming this is an actual power play by Palmetto, does Novartis and other MAC's simple acquiesce to Palmetto? JMO like all bureaucracies, Novitas and other MAC's will fight hard to keep all MAC's equal (unless a clear expertise exists) and keep there current power in there geographical areas. Therefore it would not surprise me that Novitas approves the 4K score test if it believes it has medical value to Doctors and ultimately the patients (which it clearly does).

On to the other important topic in this case - whether additional prostrate "screen tests" can be approved by MAC's for reimbursement by Medicare.

First, is the 4K score test actually a screen test? I think Opko can argue it is a probability indicator of aggressive prostate cancer and not necessarily a "screen test" for prostate cancer. Again beyond my expertise to give a valid opinion.

Second if it is a prostate screen test can it be approved for medicare reimbursement? The 2006 law id's 2 prostrate screen test that are clearly approve for Medicare reimbursement - the PSA test and another one (not sure of its name). But my reading of the law is that it doesn't necessarily eliminate other possible tests. The wording of the 2006 law seems to always use the word "include/including" (in it's varies forms) when it id's the 2 approved test and doesn't actually say these are the only 2 test that can be reimbursed. From my experience, the words "include/including" are used when you are identifying specific current examples (2 screens in this case) that would qualify for reimbursement but also allows additional "screens/tests" that are proven to be effective to be added at a later date as they are proven to be effective.

It seems to leave the door open for future improved tests. Which is reasonable in the rapidly technologically advancing medical field. Things change in medicine on a daily basis. In fact the PSA test has proved to be far less reliable than thought in 2006. It is only reasonable to believe that new improved test/screens developed as medical advancements are made can be approved for medicare reimbursement. To think otherwise is totally foolish (Palmetto's stand that medicare reimbursement is limited to 2 prostrate screen tests from 2006).

Bottomline, JMO there is still a reasonable probability that Novitas approves the 4K score test for medicare reimbursement.

A prominent local urologist again told me that the 4K is a good test and in fact in did 23 of them last week.