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.
What that post did not include is that Rayaldee is neutral to both Calcium and Phosphates. The two generics leach calcium from the bones, Rayaldee does NOT. Phosphorous levels interact in the body and impact calcium, both issues create side effects which can in time cause death.
Great. The one above basically covers the befits of Rayaldee over the competition, I will have to find other post to see if it is missing anything.
There is a fair chance Rayaldee could become a standard of care drug. If you talk to nephrologists and simply say we have a long acting vitamin D drug will you use it at 3,000 per year the answer will be a resounding NO, we will simply use OTC.
Now if you tell them this Long acting version not only corrects S H P T but it also corrects Vitamin D insufficiency, plus it is neutral on phosphorous and calcium you get a resounding YES, we will use a Long acting D if it can do that.
The OTC does none of those things, and the available generics, though they might correct S H P T , they Do NOTHING to correct D levels plus they reek havoc on CALCIUM and phosphorous levels.
We might find MANY nephrologists saying, I will USE RAYALDEE for all my patients as a standard protocol.
Ease of administration, no need for the Dr. to try and manage calcium and phosphorous levels ( problem caused by generics ) corrects D deficiency, OTC does not. Corrects S H P T as the generics do MINUS ALL the SIDE Effects. Sign us UP.
One industry source said more than a hundred GlaxoSmithKline employees, many in Collegeville, were told Tuesday morning that will become Novartis employees by the end of this year or early 2015 if the deal is finalized as expected.
"We expect it will take about a year for this to get regulatory approval," she said, noting the company has formed a "transition committee" to look at employee issues.
Both these comments were made April 22, 2014, SO roughly arry could get some definitive info by late 2014 to early 2015, 4-7 months.
All the small cap bio's I follow are down in the past two weeks. Large cap pharma doing much better.
I could find no word on when the Novartis deal is to be finalized.
If arry gets the drug back and the phase 3 results turn out positive, they then become a serious take out target.
At this point too many unknowns. If phase 3, IF they get the drug back, IF Novartis will cover balance of phase study. All we know for certain is the ATM keeps selling shares to fund research, and Ron gets options for doing little to enhance share value.
some wealth for others.
Bouncing around like a ping pong ball today. Some one has been covering big on this massive fifteen cent pull back. Yesterday 1m available at open only 100k, now back up over 1.3M. The FIRST to COVER WINS.
Building your position along with Dr Frost will work out given that Opko will have 8 NEW items on the market in under one year.