Red and green thumbs, really? Any one have any info on the hurdles to get approval abroad? I expect a few more thumbs, umm, those take a ton of thought and effort for sure.
EirGen Pharma, Ltd., currently has products for sale in the U.S., Canada, Japan, Australia, most European countries, and more than 40 others around the world.
Opk stated the US market is 8m patients, with 12B potential revenue is they had that entire market. Globally is far more than that US number. If we figure only 16m patients, 24B potential, only needs 10% penetration to reach block buster status. Time will tell.
Just a thought on Eirgen, they have the EXPERTISE to gets the filings done in the 40 countries they now serve and have gone through those hurdles before. Eirgen will HAVE to be the one to manufacture Rayaldee for those countries because their facility is certified to do so. Think they will help on the filings outside the US, it is their strong suit. The Eirgen acquisition appears very timely. Hope it gets mentioned Wed.
They might address that on Wed. at Jefferies. Opko has operations and sales reps in many countries, need get more than FDA. Our Russian partner lists Rayaldee on their website as a drug in research, so figure it gets sold there. We have an extensive South American presence, Israel, Spain, Ireland, and Canada. Figure Eirgen their latest purchase sells drugs in 40 countries INCLUDING JAPAN, and the Spanish division is global too. So the ground work is there, matter of filing in these countries. Hope this gets mentioned on Wed.
You should know every catalyst buster, taking a long position or short position requires that info, otherwise no sense buying any stock. Asking for others to go do your DD is never good, they might lie. A good friend of mine does NO DD, he owns mutual funds. He never asks others about catalysts, he relies on his fund mangers to understand those things. I respect this friend, and the fact he THOROUGHLY recognizes his limitations at stock picking, his inability to do google searches, and he knows full well a 10q, or 10k is better left to the accounting department.
So if you really need to know these things, these things you are unaware of, start with the 2013 annual report, and work forward.
Old all time high 18.29, new all time high, 18.42 a .71% move. Percent short shares under water. 99.999999%, figured buster and Bryan nailed the 18.42 high today and dollar averaged their short. That is why only 99.999999% shares short are underwater, not 100%, I took into account their 10 shares each.
They need be in an IRA or a non margin account. So a second account might be necessary, but calling ones brokerage house and asking is the first step. Getting info on a message board, well, though it might be good, one should never ever bank on it.
That is the variable the shorts have not counted on. Opk retail longs are dedicated to Dr. Frost, as many Elon Musk followers to tsla. Funds, well, that is another horse. Fact is Retail owns a very large percent of the opk float, many have owned prior Frost companies and are die hards.
If we take out insider shares, which is roughly 50%, then fund shares, 18%, retail owns a massive 32%. That is why I posted incessantly to move long shares into accounts were your broker can not lend them out to be shorted. NORMALLY funds control short availability, opk is VERY RARE in this regard. If every single retail share was moved to non margin, brokers would need recall a fair portion of shorted shares.
Every one has heard the phrase buy the rumor sell the news. When you buy the rumor, the news gets baked in, so when the news hits, you many times get a drop. Is this not a known?
Many expecting a sell the news play, might short on up days heading into the news, as noted, short interest inched up 2m recently.
An anomaly happens in this scenario when the sell the news never materializes. In that situation when the stock inches up, or fails to drop, it is prudent to cover. Guess much of today's action is the short the rumor group, being forced to cover on the news, well one explanation, but am sure there are many.
We certainly have been bombarded here with the cake group, ie., Rayaldee news is BAKED in. Guess not all of it, I think the shorts are putting Frost-ing on this cake, UMMM, pun intended.
That Diffee in Oklahoma City had trucks does not surprise me. Middle America is SOLID FORD country. New England, not so much. I see far more Chevy trucks, and other brands on the road here but not that many Fords. I figure if they are having trouble keeping up with demand in this area ( New England ) , it is not going to impact sales that dramatically. They are likely taking care of their farm belt and heavier construction areas first to maximize turn over.
May be accessed at Opko investors web site. For those who also own Arry, they will also present tomorrow, Tues., at 1:30 also access is from investor relations. All times Eastern.
Notice how Opk has this penchant to do presentations, earnings releases, etc., after the close.
Figure if I threw Hillary in the title, and the topic of this board FORD, everyone would be FORCED to look. So any thoughts on Ford, you can, can, the Hillary trash, no one cares about her anyway. I live in CT, my local Ford dealer still seems to have few and some days no Ford trucks on display. Either Ford can't meet demand, OR production is still too low are my guesses.
R you sure they get all 110m, or do they get a portion if the fda approves, then periodic payments as sales milestones are reached? I am not going to go look, but I believe this is the set up, but could be wrong.
dt, 20m, have stage III, & IV, that is true. That is unfortunately the whole group of patients, not the target
market. Of those 20m, Rayaldee will target only those with low vitamin D levels. Opko gives that number at 8m as their target market.
Currently near half of that 8m, are getting no treatment, while the rest use Calcitriol type drugs or use over the counter drugs. Currently in fact, the BULK , 70% of ckd patients, who have low vitamin D fall into the no treatment or CVS type otc variety.
Opko states the US market for this patient population is 12b, so 5% penetration is 600m, I expect 1.2B after 1 year, 10%
A BIG hurdle will be getting Drs. on board at all. If they are not bothering to treat D levels at all now, or going the otc route, it takes a leap of faith to think Rayaldee will be welcomed with open arms. Opko believes because none of the current options work very well, Drs. do little in an attempt to correct D levels. The fact Rayaldee corrects both D and SHPT levels might get many converts. I think over time R gets most of that 8m market, BUT THEN I am an opko optimist.
I stand corrected on one point, that asking for priority has to be done before phase three is initiated. In practice, however, that is the usual route taken. When asking prior to phase 3, based on phase 2 data, the FDA issues you a voucher which you submit with your phase 3 data and the fast track is GUARANTEED. Fast track can be asked for when submitting the nda. Regardless, it is highly unlikely Rayaldee gets fast tracked, though it is a remote possibility, I guess that opk have asked for the designation late in the game.
As a general rule, it is my understanding, companies ask for this designation prior to phase three, and either are granted a voucher or not.
SPA is different from priority review H9. SPA is granted when you go to the FDA and say here is our phase 2 data, LOOK how great it is. Then you discuss a phase 3, and the FDA agrees to all perameters of the phase 3, and you basically strike a deal. The deal is that if you follow this phase 3 as you outline, and the data is as good as the phase 2, they will not ask for further studies and the drug will be approved. So approval is now a formality based on the phase 3 data. .001 or better success rate. Now if they fast track SPA studies, that I do not know.
I do know they fast tract priority review studies, which is different from being granted an SPA.
Keep in mind, though Rayaldee lowers PTH there are also 5-6 other calcitriol based drugs that lower PTH. These other drugs lower pth regardless of vitamin D level, and an elevated pth is NOT life threatening in the short term. Drs. can control it but it will be far easier with Rayaldee.
I would love to be able to say rah rah, Rayaldee is so good it gets priority review, and pound that point. Fact is they did not ask for priority review, and if they had, they likely would not have been granted it.
With several other drugs already treating ckd, and quite capable of lowering pth, Rayaldee is in a sense a me too drug. What sets it apart, and why it will be adopted is that the side affect profile IS ZERO. Calcitriol drugs create almost as many issues as they solve. So I guess Rayaldee is a bio-better, umm, a bio-way-better.
If CKD was a rare disease, or a disease that did not have an entrenched standard of care drug ( calcitriols ) umm, then yes, the FDA would say do the study, get the paper work here fast, it gets priority.
Plus if opk had priority review it would have been in the press release, or in several, whenever Rayaldee was discussed, so I am not guessing about it.
I believe the answer is no. Not that isn't a good drug or first drug to treat ckd caused by Vit D deficiency. The reason the answer is no is because the company running the phase 2, or phase 3 study has to ask for priority review BEFORE they initiate the study. So if you are initiating phase 3, after great phase 2 for say Dengue fever where there is no cure, and your phase 2 was great, you ask and it will likely be granted before you start your next study. You can not ask for priority review after phase 3 starts or the phase 3 is complete. EVERYONE would ask if that was the case. Priority review is generally for orphan drugs ( no treatment ), or a drug that appears to revolutionize results, extends life by say 18 months, etc..
Blue bio will get priority review, their treatment CURED cycle cell in phase 2, guaranteed they asked for and got priority review for phase 3. Fits both criteria rare disease, break through results.