I will leave the light on, but IF you are not in New England it will be a waste of electricity. Yes, visit while TSRO announces news, and phase 3 data is announced. Keeping the light on opko rising.
It is either a brilliant move or genius. NO ONE understands Rayaldee as he does, NO one. I am for the first time thoroughly optimistic heading into 2016. THOROUGHLY.
Forget you read that noise. Frost bought 30K shares yesterday, that is how he is taking it private 30-50K shares at a time. Whomever made that claim DID NOT hear it from the only person who matters, Dr. Frost. If he had IT would have said so.
I have the LW article downloaded, check it every month or so watching it MELT. That said the REAL short thesis is Rayaldee is a DUD, 4k never gains traction, and Frost will die before those items ever get traction. Truth is 4k will take TIME, but will slowly gain traction, never be that huge. The vit D test blows it away. Rayaldee is a block buster. Jane CAN do AS good or BETTER running Opko but it is more likely Frost lives another 15 years or so. Rayaldee will BE HUGE unless Google search is bogus sending me to data planted by shorts. CAN they do that ? Umm, not yet.
The timing is curious TOO, about two or three weeks before NDA for Rolapitant, 2-3 before Rayaldee data, a shot across the bow, but if I were short I would use options immediately to hedge, or cover, just in case.
Figure this way, any short under 12.95 is in jeopardy, which means all shorts.
No clue, but Frost has bought at every level, Jane just spent 1m on options priced about 7.50 late last month. So they BOTH view opko as cheap. KEEP in MIND, opko is basically private as IS. WE common holders have no say at an annual meeting, Frost owns enough that any vote passes. I have no issue with that, some might. Also as RICH as Frost is he does not have enough cash on his kitchen table to buy the 50% he does not own without selling his Teva shares, or a few others, unless he were to finance 2b, not happening. He cannot easily buy under, but likely have to pay no less than 13.00, SOOO not happening.
buying shares on the open market and CONVERTING options!!! For all intents this is a private company, insiders own over half the float. This type noise has surfaced before, it will amount to nothing. Opko will stay public, will do over 1 billion in revenue by eoy 2013, will trade in the 28-32 range.
Just a side note, Calcitriol is NOT standard of care for Vitamin D insufficiency. It DOES NOT address vitamin D at all. In fact it eliminates D from the equation. The end product produced by the kidneys conversion of D is calcitriol, so a person with absolutely no D, high shpt, can take calcitriol. The result is still no D, lowered shpt, high blood calcium, low blood phosphates, eventual complications, dialysis, death from complications.
It is the most widely used drug for shpt, that is true, a drug that creates a myriad of problems though. Bottom line, it creates more problems than it solves.
You have nothing to lose by calling Opko to see if there is a chance to enter a follow up study The current one is closed out, but they are planning a calcitriol vs rayaldee to launch VERY soon. Not sure if it will be only the patients currently in phase three, or if any new patients will be added. Not sure where you live but the study has many locations.
Best wishes, Rayaldee should be on the market before eoy 2015.
It will replace calcitriol, hands down. If U R vit D deficient calcitriol is a horrible choice. Rayaldee allows the body to MAKE it's own calcitriol in just the right amount. IF it did not do that then Rayaldee would have the same calcium phosphorous issues as the generic drugs.
That is what is under the radar. If the calcium and phosphorous levels are correct on Rayaldee, calcitriol level has to be too, it is the regulator of calcium but it can only do that job in the presence of appropriate D.
For whatever reason, these ckd patients have trouble making D, but not calcitriol, well that is my conclusion from what I have read. I could be wrong, I AM not a DR. but I think I understand the two drugs.
I really have no opinion about their choice to short or not. IT has no impact on my decision to invest in opk. I have been posting, now several times on Rayaldee. It is for my benefit, as well as those looking to understand how the drug works. I have to look this stuff up, and then figure out what the heck is all this medical mumbo jumbo, lol. Understanding my companies and their prospects makes them a hold or a sell. I am ready to raise my sub 4 cost basis, Rayaldee will be that good, and I HATE raising my cost. This drug is going to BLIND SIDE the uninformed. Opko will gain MAJOR market share. I am the conservative long here, lol. I think my 400-800m year one revenue estimate is off a little, : ) now that I MORE fully understand the competition and how Rayaldee works. There is no competition.
What amazes is that a MAJOR piece of the short thesis is based on LW's lack of understanding of HOW calcitriol works and how Rayaldee works. Running with the idea it is only a long acting D, but not grasping why that is so unique, why that will create a paradigm shift in treatment, priceless. Rayaldee will be standard of care, period.
Note the functions of this drug. Calcitriol regulates calcium levels in the blood and bones and also adjusts the pth levels. This drug also inhibits the release of calcitonin, calcitonin regulates blood calcium. This all sounds great except with D deficient patients calcitriol stays in high gear pumping calcium out of the bones into the blood. Part of this imbalance is tied to D, the D receptors, and calcitriols reduction in blood phosphates. So if you use this poor choice of a drug the Dr. is forced to titrate ( adjust for and control ) ( measure elements in blood ) of calcitriol, phosphorous, calcium, D, and likely others. What a MESS.
Rayaldee has NO negative impact on these so no running around trying to adjust a half dozen bodily functions.
If you ask a nephrologist if they would recommend a 3k monthly long asking D they will generally say NO. NOW if you tell them this drug because it is specially formulated keeps phosphates, calcium, calcitriol at healthy levels and it lowers pth to healthy levels too. YOU will GET, sign me up.
WHY? There is no trying to adjust a half dozen items. It is either one rayaldee pill a day or two. The body then corrects the imbalances on it's own, once the D level is held steady at healthy levels.
Miami, long is always appropriate, but some how it made me laugh. Now if I say long it might be more appropriate, but then I might be accused of bragging. Too much D can do that.
Now it also might be that though a patient is on Rayaldee that the patient might still need very small does of the generics in late stage 4 or 5 if the kidney is shutting down and completely stops converting Rayaldee to calcitriol. In the earlier stage 3-4 ckd patients ALL they will need is Rayaldee however.
From the CC, they said it will be before rayaldee is launched. From my perspective these are two VASTLY different drugs. Calcitriol ( the competition )is the final product produced in the kidney, then released into the bloodstream. This synthetic hormone skips steps, and ignores D levels, though it does lower SHPT. The issue is if the D levels are ignored and you treat with Calcitriol all the mineral levels calcium, phosphates etc., get out of wack and leach into the blood. This happens RELATIVLEY fast in under 3 months. So NOW WHAT DO YOU do? You under prescribe the Calcitriol to minimize mineral depletion. Calcitriol just poured into the blood stream this way also usually lowers SHPT too far which creates even more dosing issues.
Rayaldee goes back a step or so in the process and is not concentrating on calcitriol, the final product. When the skin processes sunlight into D, it goes through two steps, the second step produces D that can be measured in the blood, identical to Rayaldee. D that has reached this second step helps the bones stay hard and calcium and phosphorous to be in balance. It also simultaneously lowers shpt and likely allows for an appropriate level of natural calcitriol to be produced. The issue with the KIDNEY patient is not that they can not produce their own Calcitriol, but in some ( Rayaldee target market ) they cannot get the body to convert sunlight into a high enough D level. Rayaldee is BY far the SUPERIOR product.
So a comparative study is planned, and all it really needs show is that Calcitriol creates mineral imbalances relatively fast, for Rayaldee to show superiority. Even if both are equally capable of lowering shpt to the same level Rayaldee does it as close to nature as you can get with NO side effects. So NDA gets filed, superior study gets finished before approval, Opko adds that info to the label later, but the drug is on the market NOW.