Goes in steps 7.00, 6.80, 6.40, then 5.80, then... not sure, 7.00 a given, 6.80 likely a given., the rest depends on MD Anderson response, it is not up to nwbo.
This sets up a lawsuit against the street. It really does. Think, LP is a legal eagle. THERE was no REBUKE by MD ANDERSON, just one interview, all 3 will get sued. Maybe LP set up AF.
phase 3, the real deal tells all.
Why do you think it is about to take off? So far the response is muted/non existent.
Arry is a likely take out target at some point, I figured astra or Novartis, but now this could be a wrench as astra would have to likely get rid of the binibetnib. They did not mention asthma, questions were guided by Wells. Not 100% sure but I think there are ONLY about 7 known mek inhibitors. If arry gets it back someone will come knocking, they have plenty of items but the mek would create interest especially if the phase 3 pans out.
I agree Arry not in a financial position to continue the multitude of on going studies. That said, if they get Binimetnib back ready for FDA approval it could be a game changer. They would likely need put the other Binimetnib studies on hold for a year until revenue kicked in, or get a partner. Still a wholly owned mek changes the biolandscape. Arry becomes an instant target, or so I think, am guessing.
If it is a FAR superior delivery system, even if your drug is not as effective, it can test out to have far superior results. Would you rather have the best selling asthma product or give your edge to the competition? Opko's asthma drug is preclinical, licensing Arry's makes all the sense in the world. Time to market under 2 years. If arry's tested = or even slightly below the best asthma drug, the delivery system can put it well over the top. Yes., I hope it got to Frost, and hope OPKO at least looks at the study. Going from preclinical with our in house drug to market could be 5 years minimum.
Pass me the pipe, um., Opko cannot because of arry's cash burn rate, 64 million annual, add that to opko and it is a real issue. Doubt it found him, but through opko investor relations I emailed info about arry's asthma drug and asked it be forwarded to Dr. Frost.
Did you listen to the Wells presentation? More interesting than others, a few real questions asked, appears they think they have a real shot at getting the mek drug back. Curious on peoples take on this idea.
Thom, the arry Wells Fargo presentation is archived, a must listen to. Appears arry might get back their out licensed mek drug from Novartis after phase 3 is complete and own the drug outright!!!!! All depends on the gsk takeover terms and regulators but it could be a game changer. Hope this finds you but robo is hard at work.
will be handing Arry a completed, ready for FDA phase 3 mek study. No guarantees on this, but Arry is now thinking they get the drug back in time to file NDA by 2016. This was MY takeaway, so others please listen and chime in. Also it appears Arry might get back the rest of that portfolio but could not quite figure that consequence. If they get that entire portfolio back they are an instant take out target. My thought is that to continue ALL THOSE phase studies is beyond arry's financial capabilities, so they might need put a bulk of those studies on hold or get a partner.
Hard to push a stock when the available shares to short has dried up, IAB currently only 100K, so little ammo to push it to 7.50, requires retail selling profit taking to drive it. So far holding up well, we will see.
Holding well right here, bet the line gets drawn just above 8.00 before the next move. 7.80 not completely off the table, but after this run, this pull back is weak.
Thinking if it closes below 8.43, could create a buying opportunity tomorrow or Friday in the 7.80 range, barring any big news. Though it did break out, failed to hold over 9.00 so what do we retest, where is first line of support?
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK), announced that it is expanding its global presence with the establishment of a global supply chain operation in Ireland. OPKO is recruiting employees immediately for a range of initial positions, including material and vendor selection, quality assurance, quality control, manufacturing, logistics and sales functions to support the ongoing global launch of its 4Kscore™ diagnostic test and in anticipation of the commercial launch of RAYALDEE™. OPKO's supply chain operation in Ireland is also expected to manage the global supply of other products over the next several years. The Irish operation will also serve as a global holding company for many of OPKO's non-U.S. subsidiaries and as a platform for future strategic acquisitions.
"Ireland's government and universities have a proven record of commitment and robust partnerships with regard to education and training for pharmaceutical manufacturing, quality assurance, quality control and supply logistics. As we build our global supply chain and quality team, we are excited to choose Ireland for its highly skilled and educated workforce," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
I guess when we buy companies it will become part of this division now, Tax advantage for sure.
Also from the Opko website, under 2014 new releases, I cut and paste and we find :
So it has been spelled both ways, I guess both Rayaldy and Rayaldee are TM.
OPKO Completes Patient Enrollment in Third Phase 3 Trial of RAYALDEE™
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), has completed patient enrollment in the third phase 3 trial of RAYALDEE. This trial is designed to evaluate the product's long-term safety and efficacy in treating secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
well running dry, AGAIN.
Bingo, keep in mind how lousy otc is though. If you figure it is out of the body in 2 hours max, that means 12 doses if it is a vitamin d correctable indication. That said, I only think Rayaldy has a shot for a secondary indication for seniors, and could be used heavily in senior centers. UM., seniors fall, and get hurt. D reduces this and forget why it helps. A single dose rather than multiple doses preventing broken hips, backs etc., is a possibility. Waiting on opko on that one, but it is a possibility.
This all said, why Rayaldy can be a dud or HUGE is the answer.
The patient population in the US undergoing dialysis who pay for a " TYPE " of D therapy is 4 billion. The therapy is lousy, not in the class of Rayaldy, NO COMPARISON. There are also 4 billion using OTC which are throwing money away basically, and 4 billion where Drs. give nothing.
So the market in the US is 12B, but looking at the under treated, or not treated = 8 billion !!! Drs. test all levels, pth, calcium, phosphoros, etc.,. and THEN decide OTC is useless, try OTC, or go with a script that will help but raise serum calcium, hmmm.
I think UM, chaching, 2028 patent expires. Did any of you Opko longs remember that we only put a deposit on Rayaldy? OH YAH, we only paid 1/3. IT is a prove it drug, FROST is a genius when it comes to deals. Shares in the deal LOCKED up!!!! IF we sell X they get X shares, IF more sells, they get X more., GENIUS.
Rayaldy will dominate this niche market, the developers get paid, so do we, but likely with less dilution, GENIUS.