Only data I found on it was at the opko site, said further phase 3 study will start first half 2016, so no completion date given. Apparently not double blind, or set up to do interim data peak. Said does AS good as existing drugs, BUT less side affects.
They are crushing most items out there, warranted and unwarranted, not just biotech. SBUX earnings were actually good, down like rock, dnkn ditto on a beat top bottom, aapl hit within .50 of year low, gild down over 8, and on and on. A handful of up items, you know, the ones with pe's over a thousand, but the likes of aapl gets a 12 pe withs it's 200 billion cash = to 1/3 of cap. I do think STX hits more lows, but most of this action is cause they can, not because it is deserved.
The original pudfa for RAY was an 8 month review, the current one is 6 months, the former a standard review period, the latter accelerated review. From what I could find, this new submission could NOT happen without the FDA signing off on Cats letter. Ticker COLL was denied approval due to a patent suit, the fda delayed approval for up to 60 months or some massive number, until court resolution. The court sided with COLL in Dec, fda approved in April, 4 months. Point being, the fda wording always has the phase " within " X time period, though most are at the exact date, a few, slightly less than 3% are late. In circumstances where the fda has delayed due to an outside factor, court litigation, plant issues, the " within " phrase comes into play more times than not. I for one expect WORD in 120 days or less from the new filing, we will see. I DOUBT it runs the full 6 months, approval with be pre market and earlier than the stated pudfa date, no one will know when, and it will surprise some, not all.
Coach nice post. My lead in post to this little ditty was me letting that 8th grade punk out for a walk. I strive to only post facts, and if NOT facts per se, my opinion, which I back up with facts, or speculative scenarios that use the IF A happens, Then B happens format. Thought I let the punk out for a walk, I never put a posters name in the title, though I see at least one who thinks they have Carte Blanch to put mine in theirs.
This stock has had two run ups, umm, HUGE % moves on short covering in the past 3 years. Yes, selling at 19, would have been the right move, IF you KNEW it would crater. At that time the chart looked to pull back pre merger to 14-15 MAX, base, and likely rise post merger. So the chart and price action, caught many off guard. WELL, not the short funds, they went from NEAR zero shares to short, as opko hit 19, to a bonanza with the brli dilution.
Price will follow revenue, I expect two years of 100% revenue growth, so we will see.
The trouble with tribbles, is that tribbles don't dribble, but tribbles would dribble if a wood chuck dribble but a wood chuck he chuck wood. So I repeat today what I said today, next 10 FDA, accumulate HERE.
you that I said it today. I have been saying this same thing for a long time now, and I do hate to keep repeating
the SAME DRIBBLE over and over today, then finding myself obsessively compuled to remind you tomorrow, that I said it today, but by then today is YESTERDAY. So keep reading this DRIBBLE. I get a CALL right EVERY once in A while, and when I do, I remind you of that fact not only today, but tomorrow, and then the NEXT tomorrow, about how I got things RIGHT one time, but then, no need read on, I WILL repeat this dribble tomorrow, and you can read this same dribble then.
This by the way IS ALL positive DRIBBLE, and I hear if you only write positive dribble, YOUR dribble has NO meaning, you NEED negative dribble to give impetus to that positive dribble without it, BAD THINGS can happen. You cast dribble KARMA from here to there, and LEAST I forget, all the way to TOMORROW. WHEN GUESS what? I will repeat this DRIBBLE, to perpetuate more DRIBBLE, in the HOPES of over coming DRIBBLE KARMA.
So anyone who does not get the point of this DRIBBLE, THIS board has a master, and one or two clones, or is that clowns that are MASTERS of DRIBBLE, that WILL tell you TOMORROW, what they said TODAY.
THE arrogance and self pride of some people to think this dribble is in any way about their dribble, I mean, YOU need remember a screen name for that TO HAPPEN, and I have so many blocked, there basically is no DRIBBLE at all.
WELL TTFN, ACCUMULATORS, you know, INVESTORS !!!!!! Those who plan on being here for the next 10 FDA approvals, YES you YOU know who you are.
OH BROTHER, so until tomorrow, you know when I repeat...................................................the .............same ..................dribble ..........as...............TODAY.
My point is NONE of it matters, unless you are trading in and out daily/hourly. Opko can weaken to 8, I would buy, I would not care that my portfolio moved DOWN, or stayed down until that item recovered. PUT another way, if it drops, it has absolutely nothing to do with my plan or long term goal, it helps me buy good companies at better prices for a higher eventual return on investment. Dr, Frost has a plan, as the intro title says. I read that plan over and over before I bought one share. I missed a 1.00 move from about 2.88 to 3.88 which took some time. I looked long and hard, studied the ceo., I am watching his plan unfold. SHORTS, will leave, and they fuel the OPKO spikes. Watch the REVENUE double, put on blinders to the noise.
I have stated a few times. Dr. Frost's strongest asset is his talent for growing revenue, he has amassed Billions from that talent, His other biggest strength is to see medical trends ahead of others, altering his plans to get in front of that trend.
NOW my GUESS is you are on margin. it might seem safe to think BORROWING MONEY to invest is safe, it is NOT. I know from first hand knowledge, losses become 2x the drop in a bear market and they can happen in two minutes... Think NOT??/
Sept 11, wiped out thousands of margin accounts, 2008, 1000's more. PuT no more than 10% or zero % on margin, .33 moves vanish that fast.
If a .33 drop is concerning then by all means sell. My strategy in the market is to accumulate best in class companies that have increased their dividends every year or near every year. That angel of my strategy is to guarantee an income better than my pension or SS. Good companies can get trashed in the short term, be ready to buy those when they drop, but hope for more than .33
I anticipate opk to double it's revenue each year , this year a given, BRLI did that. Next year 4k should be in OVER drive, Claros release, Varubi taking hold, Eirgen should ramp opening new production, HGH ( pFE ) adult late 2017, Rayaldee will launch in the Eu, Asia, Australia, SA, either through divisions or partners.
2018 we gain HALF of the PFE HGH franchise, might be in the 300-400m range to opk, if oxy hits a bonus, and figure there will be other drivers.
Share price will follow revenue. Other than dividend growers you need companies like opk, FB, and that type group that are doubling revenue y/y and doubling eps. y/y. Opk is a young co. it will not trade in the 10 area for decades, but planning to hold for a decade as revenue doubles is planning ahead, and part of my plan.
What opk does this week, month, fda noise, is just that, create a plan for wealth, stick to the plan. A .33 move on volume? Does not compute.
Yes, I think so, I am convinced he/she is into VOODOO. A topic considered an attack will bring about financial RUIN TO ALL, so figure a doll, needle, a few candles, something WAY out there is going on. That or megalomania has set in, they actually think they HAVE THE POWER!!!!!!! TOO funnty.
I think I bother a few though I usually NEVER speak their name, lol. I know at least one who reads what I write and is so self absorbed they KNOW it MUST be about them. Someone predicting down daily after day will get it right once in a while. SAY that, mention no names and they will excoriate you thinking you are bashing them??? Mention no names and the GUILTY step right up to take credit, lol.
Dr. Frost stated his plan in a prior Mission letter about 4 or 5 years ago. Since then there have been more recent CEO letters on the Opko home page, but I want to summarize Dr. Frost's earlier, might be earliest stated game plan. Of course this is all paraphrased, but the facts are presented as accurately as possible. I read this mission statement no less than 8 times, basically this was/is the STATED OPKO strategy:
The plan is to create a diagnostics division that is profitable. The profit from the diagnostics division will be used to fund R&D, and phase studies. To facilitate the sale of our diagnostics, and eventual drugs, we will opportunistically establish a global footprint. He said we are taking this approach because R&D can be very expensive and he believed he could fund most R&D internally once diagnostics was profitable.
How is he doing with the plan?
He has acquired the 4k technology, the Claros platform and BRLI, the company has had 2 profitable or break even quarters in a row. Since this letter, we are in Israel, Spain, Russia, Chile, Mexico and several other countries. He out licensed Varubi, so no expense there, but did fund several phase studies through a note offering, revenues, and of course the PFE deal.
To those who never saw this in black and white, Opko might appear a strange mix of companies. NOT so, EVERY moves was by design, stated years ago as his plan in an earlier or earliest Mission statement.
So I have been VERY happy cause I knew the plan and have watched Dr. Frost masterfully execute it. Those newer investors, I throw this out here to lend a little clarity to Dr. Frost's intent, and mission.
Yahoo sucks, I tried to copy and past the mission letter info, MOST here never read it, YAHOO refuses to allow me to copy and past my own work.
FUNNY TOO is if I do rewrite it, I need be careful with the header line, or they will kick it out a second time.
About 4 or so years ago Dr. Frost put out a mission letter to share holders, which has since been replaced by more recent letters to the share holders.
In that real early mission statement Dr. Frost said, and I paraphrase: My plan is to be able to pay for ALL R&D through earnings. The R&D budget will grow rapidly once revenue warrants that expansion. To accomplish this GOAL, the development of a robust pipeline, OUR plan is to build and grow a profitable diagnostics division. To facilitate this we will develop a global footprint.
Since the writing of that letter he has purchased and developed 4k, NOW launched, Claros about to be, and has bought brli. Opko has hit break even or profit in back to back quarters, second drug Ray has hit fda, oxy is in phase 1. Opko has divisions on several continents or owns major positions to help as promised.
NOTHING HERE IS random, it is DR. FROST executing a plan he stated YEARs ago, that he is methodologically executing to a T. To outsiders they see a hodgepodge of assets that appear unrelated, trust this, not one move was not throughly thought out.
The float which has risen as Dr. Frost/opk started with basically no viable technologies, but has bought technologies with shares. The % short has ALWAYS been high, REAL high, as the float has risen, short number has risen. THING is historically when that % drops Opk has hit new highs, umm, but it takes about a 25% drop. It is the We hope a billionaire fails phenomenon. Dr. Frost's skill set might not be perfect, but he excels in one area. HIS greatest strength is growing revenue, and has proven a master at it in SEVERAL companies. IN time, HOPEFULLY he has plenty left, the shorts lose here as in IVAX, KEY, and TEVA, ALL his start ups HAD outsized short positions, he attracts shorts like a BEAR ( pun ) to honey. He grows revenue as if he has a printing press in his basement, just that it takes time to get all those printing gears lined up, it happens.
Hilarious, lol. Your prediction beats MINE hands down. You make that one for a week, you will be right 5 of 7 days, and be far ahead of guy who says DAILY ok down tomorrow,, lol. WELL unless you predict market will not open Sat. AND Sun.., umm, you could hit 100% accuracy, but then I can bet I hear you were wrong cause tase traded and U missed that call, lol.
Investor relations link at opk has FDA filings updated daily, forget yahoo for that type info. Dr. Frost buying is no reason to invest, he is not buying cause HE KNOWS something. He has been buying since the company was formed, so if it was on privy news or insight, opk would have hit 1000 years ago. IT does reduce the float, so the float is not 545m but less than 1/2 that.
No IDEA on approval, FDA will march to it's own drummer. RADAR, that happens A LOT. Market tanks Opk goes up and it is exactly what you said. People long one item getting crushed, so they cover a few short positions to get margin back in line. A down market day DOES not ALWAYS mean opk follows, MANY times it bucks that trend.
CAPTAIN obvious strikes again, aapl misses, twtr misses so I think down, lol.
Today I think entire market down, but oil bucks the trend, ete hits 12 plus for first time since DEC, and aapl goes below 100, banks will be mixed, tech and biotech weak but bio mixed, slight upside bias, metals aa, fcx metal/oil up, twitter gets smacked to new low, dwa likely up as coll, but ba likely down.
Like that blink squirrel finding a nut, or that broken clock. As I have said, uptrend in tack, two steps up, one back which equals 9 up days out of 12, umm, exactly. You can not get any better than that, predicting 9 up, 3 down and nailing it right, LOL. That is cause I get tomorrows paper today, and UMM, bet against options expiry, weaker volume, and board posters who say down tomorrow every day.