ZIOP. CEO Laurence Cooper (MD Anderson). Pipeline car-T plus "rheo switch" from XON. Randall Kirk investor (CEO of XON). Do the DD.
The Rayldee trials were conducted under SPA design guidelines. Which means the FDA already approved the trial designs. As long as those guidelines were followed, that only leaves the data as the subject of approval or not. Judging by the street's reaction to the news, it appears the street knows the approval is virtually in the bag.
FDA Accepts OPKO’s New Drug Application for Rayaldee™
OPKO Health, Inc. (NYSE: OPK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review OPKO’s New Drug Application (NDA) for calcifediol modified-release capsules (proposed trade name, Rayaldee™). In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
“FDA acceptance of this NDA should be cheered by healthcare professionals who care for CKD patients,” commented Dr. Kevin J. Martin, Director of the Division of Nephrology at Saint Louis University School of Medicine. “If approved, Rayaldee will provide a new therapeutic option for controlling elevated parathyroid hormone levels in this large and undertreated patient population.”
OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act (PDUFA) date in the FDA’s 74-Day letter, which the Company expects to receive by mid-August 2015.
The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.
Well, if I understand what you wrote (and I'm not certain of that), you too are focusing on the cost of the test. You ignore the cost of the procedure which the test will preclude in a great number of cases. Then, you ignore the cost of the complications that arise from biopsies which were never necessary to begin with. Insurance companies have to pay for biopsies, whether needed or not. Then insurance companies have to pay for the complications arising from biopsies, whether they were needed or not.
And there always has been the matter of "cost shifting." That concept means that those who can pay pay more pick up the slack created by those who can't pay. It has always been the case that uninsured people presenting trauma or dire symptoms go to the emergency room. And they get treated, stabilized, and maybe sent to another hospital. They can't pay, and don't pay. "Cost shifting" allows hospitals to charge insured people more to recover what they lost by caring for the uninsured. And insurance companies are the payers in that case.
No. That reimbursement level is not IMO, unreasonable if one considers how many biopsies it might preclude. And $300 bucks is a joke. One must remember it is not JUST the cost of a biopsy but the unintended consequences of a biopsy that mean additional costs that the insurer MUST pay for.
As one who is familiar with insurance companies from the stand point of a "field underwriter" (aka, insurance salesman), I would rank the hierarchy of those who are happy with the advent of 4Kscore as follows:
1) Insurance companies;
3) spouses of patients; and
There are at least two reasons why they don't:
1) insider info, or
2) looking for attention.
Time will tell. I'm not going anywhere; are you?
That would be a month, more or less, earlier than projected. And while I have some reservations about the veracity of your statement, the BRLI deal will probably close a month, more or less, earlier than expected.
Hey, it could happen.
Well Sir, if your test comes out good, and you do actually:
"ronron270 • Feb 3, 2015 10:54 AM Flag
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I own 18,000 shares at $3.20? Id that expensive? LOL"
Then you will be doubly blessed. BTW, you could have said who is your insurer. I, for one, would like to know. I have been attempting to find an insurer that covers 4kscore using the usual google prompts. Simply b/c I expect that one or some already do. So far, I have failed to find one, and maybe, well apparently b/c I have not properly entered the right search parameters
So, if you would please be so kind, tell us who your insurer is. And here's hoping your test comes out roses.
Not too long in what context? Ages? Eons? Ain't happening soon in the context of this year, or the next, or the one after that, or the one after that. Beyond that, you could be right, but then you are probably not a billionaire and couldn't possibly know what his options are.
Oh no. You just stoked up wvwvwvwv-whatever. Just when he seemed to have cooled down.
Oh well, "buy out" chatter is better than xre tgh ehg stuff any day.
There will NOT be any buy out this year, or next year, or the year after that. Offers? Maybe. Probably. And they will be rejected. Frost, like the Blues Brothers, is on a mission from God.
Look, you are a Master Chef. You are creating a new and exciting dish that will be the rage of epicureans world-wide. And some wannabe lesser Master Chef offers to take over midstream. What oh what do you do?
If you don't know..........you just don't know.
No, and so much for my fabled memory. Searching is better.
It was one called bjoel5150 who dug up the prices at the time of the various forward splits.
So, from 23+ to 33+, splits are possible. 10K becomes 15K.
15K becomes 18.75K. 18.75K becomes 23.4375K. It could happen. And all without ever going over $3X.00 a share. And that will surely happen.
"The shorts are terribly done. They got run over by opko share price. Time to sell all their houses and asse()s."
There, I fixed it for you.
Thing about risk is, if there isn't any, there's no reward. The greater the risk, the greater the reward and vice versa. But where you see risk, I see not so much. Of course, if flaming boulders fall from the sky, and giant fissures render the Earth into fragments, and the East and West Coasts crumble into the seas, all bets are off. :-)
Oh, but then you are much older than I. I was born near the end of WW2. :-)
And everybody forgets, or doesn't know, the history of IVAX. There were 3 forward splits. If one has the bells to hold on, not try to time the market on this gem, what one has will probably grow. Let Dr. Frost do the heavy lifting. And to my chagrin, I can't remember just now the poster who provided this information. Maybe latter on tonight, it will come to me. He is an infrequent poster, but a poster of pertinent information only:
Announce Date Payable Date Ex Date Ratio Optionable
01/14/2000 02/22/2000 02/23/2000 3-2 29 1/6 price at announcement
04/23/2001 05/18/2001 05/21/2001 5-4 price at announcement= $33.31
07/15/2004 08/24/2004 08/25/2004 5-4 $23.16 price at announcement
So, you see, if history repeats........or rhymes.......projections of future stock prices are unadjusted for splits.
And, since you can trust me, there was this online interview with Frost where the subject of how much he sold Ivax to Teva for was said to be 7.5B. And Frost replied that it was closer to 10 billion b/c the price had gone up by the time the deal closed.
Those that are still arbing the OPK/BRLI deal might want to take that into consideration.
Hmmm. I think the provider of the above price-at-time of split info was Opko-something. Pretty sure about the Opko part, still can't remember the "something" part. Opko-Long? Maybe.
The R/S if it is done will be to qualify for listing on the NAZ. Which is why the Club has taken it down now and then to under a buck. Of course, the Club has had "assistance" from the lousy market. Of course, the Club is the entity creating the lousy market.
If they do a R/S, I hope they will honor the preference indicated by the votes, AND have the good sense not to do an R/S during a lousy market.