Stuart M. Sprague, DO, FASN, is a graduate of Yale University and Emory University School of Medicine, completed his residency at the University of California, San Francisco, and a nephrology fellowship at Brigham and Women's Hospital. He is a Professor of Medicine at the University of Chicago Pritzker School of Medicine, and Director of the Division of Nephrology and Hypertension at NorthShore University Health System. He also serves as a member of the ASN Conflict of Interest Management Committee, Leadership Committee of the Global Bone and Mineral Initiative, and editorial boards of several prominent nephrology journals. He is internationally recognized in the field of bone and mineral metabolism.
One thesis that will change if they get the drug back is the list of potential suitors. I felt that either Novartis or Astra would buy Arry rather than pay royalties. Owning 164 outright precludes that possibility now. Pfe becomes a possible suitor instead. They went after Astra and failed, and mentioned the mek research as one of several reasons for seeking a deal. Rather see Arry get two drugs marketed before they even think about selling, but if they get an offer, they will likely jump at it.
A buyout if B gets returned becomes a serious possibility.
Charles Bishop is the head of the renal division, but founded and sold Bone Care International, the inventors of Hectoral.
He will advance Rayaldee and look at similar indications as he did with Hectoral. From a bone care international filing:
In addition to having a role in parathyroid function and calcium and phosphorus metabolism, vitamin D
hormones have an important role in regulating the growth and diÅerentiation of skin, prostate, breast and
colon cells. We are investigating the use of Hectorol Capsules, LR-103 and BCI-202 in diseases associated
with hyperproliferative or neoplastic cell growth such as cancers of the prostate and breast and psoriasis.
Our principal executive oÇces are located at 1600 Aspen Commons, Middleton, Wisconsin 53562 and
Well getting either revenue will cover their near 100M in annual losses, last year 85m, plus it might put a stop to the Atm system. It takes a year after filing NDA, to get approved, so this is a late 2016 story regarding real revenue. Figure they should get both a Novartis drug, owned or not, and an Astra drug hitting the market in mid/late 2016, if approved. Seems a LONG way off, but two solid shots at goal, 24 months, a good risk reward. Putting this in a box labeled, do not open until Christmas, 2016.
regarding Astra: They’ve invested very prolifically over the years with literally dozens of clinical trials and even today many, many Phase 2s ongoing and it has led them to the these three Phase 3 trials that are ongoing today.
Uveal which we expect to be filed next year, uveal melanoma, but -- and then thyroid, which I mentioned earlier, but the really absolute largest opportunity for MEK in general is lung cancer and AstraZeneca is currently and has been for some time in a Phase 3 combining docetaxel and second line KRAS mutant lung cancer it's about the 25% of lung cancer and we believe just that second line indication could be worse -- would be a market of about $1 billion.
AstraZeneca has mentioned their interest in a first line program. They haven’t made any specific commitments yet, but a first line program in KRAS lung could be worth an additional $1 billion.
So in a nutshell, we see binimetinib being filed next year in an important area, but then relatively rapid follow-up in BRAF melanoma and then ovarian characterized them both as in the sort of $700 million to $800 million range. The BRAF melanoma and ovarian in terms of potential and so this could be very valuable in the near term.
This drug does not cure ckd, that said, it might keep patients off dialysis and allow stage 3-4 patients to lead normal lives for many many years. This drug should have been granted break through status by the fda, but I believe Opko would have had to apply for that designation. 96% of patients benefiting with shpt gradually returning to a normal range might not be a cure, but the benefit is as good as if it cured ckd.
His comment that the new goal of physicians will likely be, well in his words:
"Gradual reduction of elevated PTH towards the normal range is likely to become the new treatment goal for predialysis patients whose secondary hyperparathyroidism has not become firmly established," stated Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine.
Key phrase Likely become " new treatment goal " ie., standard of care treatment.
"Currently, these patients are treated with ( otc or calcitriol ) high doses of nutritional vitamin D, but fewer than 50% show an adequate response.
So, 1/2 do NOT respond, not very reliable outcome with current standard.
Inadequate correction of vitamin D insufficiency with nutritional vitamin D allows secondary hyperparathyroidism to become established and less responsive to treatment. The phase 3 data with Rayaldee show that this product is highly effective in correcting vitamin D insufficiency, allowing more reliable treatment of these patients."
MORE reliable, 96% of patients benefited vs 50%, and even those in late stage 4, with minimal kidney function benefited.
The market is not giving credit for these great results, of course many think Lakewoods take that the drug might help 5 out of 100 patients is still considered valid. That is likely true in STAGE 5 ckd.
If the market misses how big this drug will be today, fine, the revenue will convince the market once approved.
Miami, the moral thing to do is use the ignore button, and whatever we do, do not respond to the robo guy. I hadn't bothered putting him on ignore until he started with his hoping Frost to drop dead, figure how did I miss putting that sick pup on ignore, well, I fixed it. That is basis of his short, Frost's age, warped mind.
Google interactive brokers, the short availability is free at that site. They allow you to check like 20 a day for free. I follow a couple stocks short availability to see if they are running out of ammo. Funny is opk, for a month opened with a limited number in the Am, but got over 1m every day by around 11:00, except today, most shortable shares have been used, or removed from float, at least for the day. Opko is in Russell 2000, DOWN every day for near a month, opko getting taken along with that index right now. If Russel 2k turns up, opko likely follows as they add more back in.
I get the potential market size. The issue is always market penetration. If there are say 15-20 other drugs for an indication, how many get switched to the new drug? How much better is the new drug? There are some drugs like Gild Hep C where they are the only game in town, so blockbuster, but usually new drugs are me too drugs, so it comes down to getting 5%, 10% or whatever penetration the new drug can get. So total market can be 1.5B, but if penetration is 10% 150m in sales, it is a great drug, not block buster. Orphan drugs can get to blockbuster cause there are few treatments, others must compete for a piece of pie.
Now if B is the best or one of a couple, then 1b sales is likely, if it is one treatment of a dozen or so, then not so much. Ron did mention that one drug had 1b potential, I do think it was Bin
IAB having trouble finding shares to short, at 1:00 still only 4k, lowest level in close to a year. Sure other brokers have a few shares, but IAB is a good indicator.
If it leads to a NDA, then what are the potential sales of the drug? This will determine size of pop. I know Ron said Novartis thought it would do well, but potential market share either makes the drug a yawn, or a home run.
Dropped to only 3k available at 11:00, rose to only 4k at noon. Smallest number since before the Prolar deal when it showed zero on several days.
From what he has said publicly he has no definitive info on binimetnib, unless that has changed, then he can buy shares. I see he was awarded options based on the return of the drug so I think that tips the scale toward a return, or Arry thinks it gets returned. The two real questions are how will the phase 3 pan out? If phase 3 leads to a NDA, returned is better, not returned is Ok too. Second question is how will the market react to either scenario? I think it gets a pop if the news is good, but not holding my breath waiting.
in this failed to deliver market. That number has started most days in the past week at 200k, then rising to 1.9m, as they hunted down shares. I guess shares are getting harder to find, started today at a meager 30k, and instead of rising to over 1m, the number dropped to a current 10k.
1 Funds we are in R down this month = small selling based on % of fund
2 Prolar deal added 65m shares, but only about 50m non Frost.
3 before prolar NO shares to short available ZERO ZILCH.
4 Since prolar they shorted at high point 20M of the 50m, many might not have been shortable.
5 The liquid float is in my opinion, 30m, shorts net 20m that cannot get covered.
6 they attack opko board here cause retail holds their future profit, not insiders, or funds.
7 retail holds a BIG position. But in non Opko employees only about 30M, but they need U nervous.
8 they push opk up 1.00 U sell, they buy in a separate ala lw account.
9 push it down 1.00, panic, they cover.
10 2016. Game OVER.
Hit the 5.40, closed at 5.45, important chart wise to hold the 5.35. I see next support at 4.87 but maybe 4.80, charts take time to confirm, this hit all downside, and upside targets. Put major buy at 4.92, then second at 4.80. Stop loss tight at 4.65, if that fails retesting in the 3.90 range. as above major news can get this to hit new highs, or lows, keep position under 10% of play money. Dow looks to take a major tank in my opinion, and over next month it will bring down other indexes.
Retail holders = about 200, but about 30% of float, that is a big percent. Several non insiders but Opko employees own large positions, but it is safe to say 50m shares are in looser hands ie., Joe retail. Not many really, but they are being targeted relentlessly. On this forum there are only 20 or so longs, the goal is to keep it that way, or get them to flip in and out. As long as they are flipping, shorts have an illusion that there are enough shares to cover with. There isn't.
LONG number 200.