You can launch as many personal insults and barbs at my friend as you like. At the end of the day, he is a highly experienced and fully qualified nephrologist working in the field in NYC. His views are 100% completely impartial and free from bias. As a long investor, you cannot say the same about your own views, Burnaka.
I do take his views with a grain of salt, skeptical doctors haven't prevented me from previously making successful bets on various biotechs down the years. As I stated to you in another thread, I want be as sure as possible in three areas:
1. That Rayaldee does exactly what it says in the label
2. That there are huge competitive barriers around the drug
3. That doctors and insurances companies will go for it
I have a red flag on that third point...
I'm not short or long. I'm potentially interested in taking a long position, though. I am conducting full analysis Rayaldee as I believe that ultimately it will be Rayaldee that will potentially drive the stock to much higher levels.
I want to encourage open, sensible, civilized and objective discussion on Rayaldee and its chances.
The following is a direct copy and paste email from a NYC-based Nephrologist friend who I spoke with recently regarding Rayaldee.
“Bottom line from me... medically, we can't imagine doctors changing practice to this drug based on this evidence. And mind you that this "evidence" is heavily drug company influenced. I couldn't find a single thing mentioned in the medical literature about the need to develop such a drug. Google it and you'll see that everything comes from business and investor websites. One of the main things we look at when we look at a study is drug company sponsorship. In our evidence-based medicine eyes, when a study is heavily drug company sponsored it has less meaning due to bias. Any academic looking at the data would scoff at it. The days when drug companies could influence doctor's prescribing practices by taking them out to dinner and paying for vacations are over.
It's only a small percentage of Stage 3 and 4 CKD patients who develop PTH/vit D/Ca/phosphate problems and those that do are treated with non-calciferol forms of vitamin D. And NO STUDIES have shown that vitamin D supplementation actually improves survival in these patients. There are two drugs that that have revolutionized CKD patient care in the last 20 years: sensipar and aranesp. I don't think this new form of vitamin D will make much difference. Besides, all the studies lack clinical end points which doctors care about. For example, they cite vitamin D and PTH levels as evidence however this is NOT a hard clinical endpoint. A hard clinical endpoint which would change practice would be if Rayaldee showed improved survival/less mortality or less vascular events...
Thank you for your post, I appreciate you taking the time to explain some of these things. Can you confirm that Rayldee was given an exemption from head to head trials under the SPA? Are you able to provide a link that implicitly states as such? I do know they are conducting Phase III under SPA and did wonder if this is why there is no head to head test versus current standard care, but cannot find any information on the exact nature of the SPA.
You appear to be coming from an investor’s stand point making quite logical conclusions. Again, I fully understand Rayldee’s significant potential yield over Calcitriol. I am attempting to come from the medical profession’s (in particular the nephrologist’s) point of view, and from lengthy discussions with nephrologist, one thing became very clear – They won’t be prescribing differently from how they do now in absence of hard clinical data. Press releases from OPKO saying how great Rayaldee is won’t cut it. They want hard data.
My part in all this is fairly simple, I’m very attracted to the OPKO story, I’m close to going long. 22% short interest in the name is a double-edged sword, though. On the plus-side it will undoubtedly produce one almighty short squeeze on positive fundamentals. On the downside, it also means there’s clearly a large number of people out there who think Rayaldee and/or OPKO as a whole is going to tank, the sheer size of this group means they cannot be ignored. For me, this stock is all about Rayaldee. I need to be 99% positive that demand from nephrologists and endocrinologists will be there, that there are big huge competitive barriers surrounding the drug, and that the insurance companies will pay for it.
You're contradicting yourself. You open up by saying Calcitriol is not the standard care treatment for these conditions and then finish your piece by saying it is the most widely prescribed drug for these conditions.
I can assure you with 100% confidence having consulted multiple nephrologists that Calcitriol IS the current standard care treatment for SHPT/CKD/Vitamin D Insufficiency.
I am very familiar with the issues associated with the use of Calcitriol and how Rayaldee seemingly navigates many of the bad side effects of Calcitriol, but it will need to prove this in clinical head to head trials.
Thank you for this information Biotechbdldwn.
I have some follow up questions.
Isn't Lunacalcipol (CTA018) a different drug to Replidea (CTAP101) aka Rayaldee?
Would positive comparative data versus Calcitriol for Lunacalcipol apply for Rayaldee also?
Does anybody know when OPKO will test Rayaldee head to head against Calcitriol, the current standard care treatment for SHPT/CKD/Vitamin D Insufficiency? The recent release makes no mention of head to head trials against current standard care treatment. I asked a nephrologist friend and another friend who works for a major business consultant and specializes in biotech/pharmaceuticals about this and both said that the lack of head to head trials during phase 3 is very unusual. They were both subsequently very skeptical about OPKO and Rayaldee claims.
Meh oil never stays down low for long. Just enjoy the discounts whilst you can in my opinion. I bought a stack of EOG today.
I feel for you. I'm down 6% after buying in last week and I'm #$%$ enough about that.
Sentiment: Strong Buy
Thanks Fourms_2000. One thing in your well laid out post I wanted to pick up on was your belief that no significant spike in revenues could ever happen at OPKO. According to basic analysis that I've done on the CKD space, should Rayaldy gain FDA approval, peak annual sales are forecast at around $6bn. This would surely represent a monumental spike in revenue? To put this into perspective, Gilead's Hep C drug Sovaldi (similar to Rayaldy in that it has no competing drug and is patent-protected) will probably do around $8bn in 2014. Sovaldi and its revenue has almost single-handedly propelled Gilead up 50% over the last year alone. That run will almost certainly continue for the next 12 months also.
Gilead acquired Pharmasset to gain access to their portfolio of Hep C treatments (including Sovaldi) and I wonder if OPKO could represent another highly lucrative acquisition target for one of the majors given the increasing prevalence of CKD and SHPT. Phillip Frost has a history of selling his companies...
22.5% of your float is still very much alive and kicking. I'd simply like to hear their reasons for believing this stock is set to fall.
Personally, I'm looking to go long, but I want to fully consider both sides of the argument.
According to my brokerage account 22.5% of the float is short this name. I definitely like the story on the long side and I've always been attracted to names that have heavy short interest in them, but I am wondering what the bear thesis is for this name? I'm guessing it is one or a combination of the following:
1. Disappointing 4Kscore sales
2. Disappointing results during phase 3 Rayaldy trials
Those assets are just awesome, particularly in the Marcellus shale formation. This acquisition would make so much sense for us. I'm positive it is going to happen, it is just a matter of time.
Sentiment: Strong Buy