Scene: Dinner table, Gramp early 60's wife, son 40's TWO grand sons. Younger GS about 10 asks Gramp, what's your 4kscore gramp? Old guy looks confused, his son said, YA DAD I got my 4kscore, a simple blood test for PC. It is predictive of future PC, so far it ALL looks great. DAD, you should get it too, grand son, YAH gramps, I need know that info too you know, Gramps laughs, you talking genetics? Kid grins with spaghetti hanging from mouth. Fade out, to GET your 4k now in BOLD print. Beat PC, a simple blood test away.
Picture Pete Rose standing there with a bat at home plate. He waxes nostalgic: Ty Cobb and I BOTH had 4k hits in our career. Now I hear EVERY man is getting 4k, and about time. Want to hit a home run with PETE, get your 4kscore today, knocking the block off pc, sounds rather, stares into space, HALLISH if you ask me.
Jeter walks up and says, count me in, 4k sounds great, Pete shakes head NO.
Ichiro walks up, repeats it in Japanese.
A little leaguer ditto.
The 4 in unison state, GET your 4k, BEAT PC DAD.
Over one Billion in diagnostics revenue.
4k received cpt code 1, in both the NCCN and EAU guidelines. Gaining global acceptance.
200 person sales force focusing on BOTH Urologists and Primary care physicians.
Inroads in the Americas, Europe, Asia, Australia, etc.,
Insurance expanding, NO SOLID number on amount
Claros device FDA submission 2nd half 2016, 2017 launch
PSA and Testosterone submission 2016, 2017 launch.
Menu will expand AFTER initial approval, Vit D, and Women's health a priority.
First drug Varubi is on the market, out licensed, IV formula to FDA, milestones and royalties.
Second Drug Rayaldee " WILL " be approved oops, PDUFA date March 29.
20 person sales force to start, launch 2nd half 2016.
HGH, for adults, phase 3 results 2nd half 2016, PRODUCT launch 2nd half 2017.
Alpherin phase 3, no TIMELINE given, so a GUESS is 2018 launch.
Oxy first subject dosed, phase 1 data readout Sept 2016.
If you are not happy with the progress Opko is making, sell and buy a coal stock.
What cl said,Completed by #$%$ly, then 2 months, Sept to go over data. Sounds like 40 subjects one month study per subject. This will give a base line for both glycemic and weight loss for 30 days of treatment. I thought each subject would be no less than 6mo. Figure a large % to roll right over into phase 2-3, and be treated no less than 6mo, but could be 12. They cannot JUST bring in 40 people day 1 for treatment, which would be EASY, and be finished in 30 days. THE FDA has you dose one subject, test for side affects, dose second, etc., for about the first 10 or so, and IF IT looks safe, you can then speed up recruitment.
If they ALL roll over, last patient goes in study in JUNE with first patient finishing 1 year of treatment March 2017, last subject #$%$;y 2017. That is IF they can and do ROLL right over. They need PERMISSION to do a combo 2-3 study from the fda, but this will NOT be 10 YEARS in the OVEN.
PS. THIS is not a RARE cancer drug with a hard to recruit population.
At a Glance: They did not update the 1500 Urologists number, they did include the EAU approval, did not include first dose of oxy on slides.
Memoria, they gave that 1500 number at the JP Morgan conference on Jan 12, said it doubled at the RBC conference on Feb 23, over a Feb 1-23 ( Drs. doubled ) time frame more or less. This is 3 weeks, since the JP conference, so we will see, a double or getting to 5k Drs. might be premature, might take another 3-4 weeks.
That 1500 is an old number. In the last CC Dr. Frost said in the last 2 weeks we doubled what OPK had done in the entire first year using the BRLI sales force. 10 reps increased to 200. Can only guess that a double COULD mean 1500 increased to 3,000 but I was never too good at math. If it has doubled again, umm, we will know in short order, but the bigger the NUMBER, harder to double, guess about 5,000 CLOSE to half, wild guess, but we will see.
BUYERS at 19 = retail shorts getting margin calls, and at 16, 17, 18 ETC., all 12 million of em WHO COVERED like a rat on a ship made of paper colanders.
Not sure RAY actually slows down the disease progression, umm, but it might, no way to know that info at this point. What RAY does do is it helps a diseased kidney to function WAY WAY better, and keeps the side affects at bay, but the disease might still progress. If it slows the progression down even a little, that would be great news.
Space he ( JEFFERIES ) had an eleven target when OPKO ran to 19.50. He has been WRONG like FOREVER. The most accurate firm believe it or not, over the past 5 years has been non other than LTS, how is that for FUNNY. Guess that GUY gets insider info or something to be as accurate as he has been.
I just remember 20, thanks dt. Think they said 20 initial, only need 40 MAX, will listen today to confirm.
They have given the number of reps to be used at every CC, funny is I forget at the moment. The GUYS from Cytochroma who developed the competing drug to RAY know how to get it to market. THEY literally CREATED the category, they will dominate it again. Fact is they set out to BUILD a better mouse trap so to speak, in a category they invented, AND they did, and they will OWN it again.
You think Jefferies GUY knows what he is talking about? His assessment might be right if and only if Ray only takes market share from the existing drugs, otherwise HE is WAY WAY wrong. I trust my research far more than his, if you want to trust his research, by all means go ahead. You and he will be wrong together, fine by me. OH, I get it, if I KNEW what I was talking about MY RESEARCH would align with Jefferies, sorry it does not work that way in the real world. If Jefferies knew anything his NUMBERS would more closely resemble mine. The speed of ROLL out is the unknown. IF fast enough, RAY could get to over 350-400m by year ending 2017 5X his estimate.
This is what I anticipate and why Ray WILL dominate this niche in the ckd population. THE largest piece of this pie goes untreated because the CURRENT armament of drugs has too many adverse events leading to artery or cardio issues. OTC simply does not work, it is these latter two areas where Ray will really get market penetration from. Yes it should take market share from the 3 dominant drugs in this sector, a 400m market. The real prize is the untreated and OTC segment which represents well over 1 billion in UNTAPPED revenue. It is estimated that OVER 70% of all CKD patients are in this untreated/otc segment, this the the real hidden revenue generator. It is anticipated that Drs. will likely switch from the current drugs to a drug with no side affects. The rest of the population, and the Drs. prescribing NOTHING will be the real challenge, that group requiring the biggest push.
The question one needs ask is, are these Drs. not prescribing the current drugs because of the SIDE AFFECTS? or is there another unknown reason.
Tram, 4k is offered at a MAJOR hospital in Hungry, has been for about a year. BRLI is a global company with labs in most countries, so no need to ship the blood to the US. Most of the tests will be ordered by UROLOGISTS and done at local blood draw centers a small % is done at hospitals anyway. Through brli/gendx and OPKO's other divisions can handle Europe, they also have offices in Australia, Japan, throughout SA, inroads in many many places.
4k is predictive of FUTURE pc, so you might have NO pc today, but have the markers indicating the likely hood ( genetic markers ) of developing AGGRESSIVE cancer 10 or even 20 years from now. You elect more frequent testing in that case. It is a yes no type test, it indicates no cancer or harmless tumors ( surveillence ) and aggressive tumors, immediate biopsy, treatment needed.
PS. IF this hormone works as it normally does, this is not a 10-12 year phase 1,2,3 study. Might go straight to the fda mid phase 2-3 combo, if results are stellar and with ZERO side affects as one might expect. QUITE possible and even probable that this study is done in 3 years, in STARK contrast to a normal timeline.
Resident FDA EXPERTS? will say this is hype, umm, just my educated GUESS based on the type drug, subject group, and perceived safety profile, and knowledge of experimental design, and FDA protocols.
Belkin, the FDA actually dictates pace of PHASE 1, they will not be in phase 2 in 30 days. Phase one is FIRST and FOREMOST a safety study, regardless of how the drug works or does not work. You dose the first patient today, and sit and stare at him for a few days, then dose patient 2, etc.. 40 subjects might take 60 days to get FIRST doses completed. WHY? IT is a SAFETY first study.
What will make this FAR faster than a normal study???
Sometimes just finding subjects with the target disease is real real slow, needs dozens of clinics, and TIME to set up dozens of clinics, train staff etc.,
Finding 40 Overweight/obese subjects, go to Monty's bar and grill. Subjects are ALL over the place. Need to have an elevated glycemic index, yes same Monty's group. So how fast weight and glycemic index drop is the cut off point, but if it is 10% body weight, might take 6 mo.
What can speed it up? IF safe, phase 1 subjects can be in phase 2-3, and they can do a combo 2-3 which cuts about 2 years off timeline, umm, DEPENDING on safety,
Rayalee over 10 year process, so it will take time, and I think AVG is 10 years, 1-3. A few can be way longer, some shorter. This appears to be the 4-5 year type study, but at least it is started. They will measure glycemic changes and weight loss, so one end point or other might move real fast, umm 3-4.