Like Einstein said;
Only two things are infinite, the universe and human stupidity, and I'm not sure about the former." - Albert Einstein quotes from BrainyQuote.com.
Not unless Rayaldee was granted break through designation. Break through designation drugs are fast tracked, SPA can also have the added break through designation granted, but if not, then it is the normal 9 months to approval. I do not believe Rayaldee was granted break through status, that designation is not given often.
I really do not know, my guess is it would be a combo phase 1-2 study. They will always need a dosing and safety phase before a phase 3, unless, the FDA tells them otherwise. The company designs the study, the FDA then approves the design and end points of the study. They could say here is a prior safety work, can we run it like this, a combo phase 1-2, a combo 2-3, where all data in 2 gets counted and the 2 becomes a 3 after X number of treated patients. Each study is different.
Yahoo is not the best place to look, but go back, click on major holders again, then click on Frost, he owns a couple million in his name, but the bulk are in his trust, which he solely controls, plus he owns 15m or so more in another trust not listed on yahoo. Insiders own 51% according to yahoo.
From the most recent earnings CC:
So on the reimbursement side, the reimbursement process in the United States requires us to get what's called a CPT code. This is a reimbursement code that is issued first through the AMA CPT Committee and then used by both the Medicare payors and private insurance payors to quote for our test. We submitted that application on July 3. We expect to have the unique CPT code issued to us early in 2015, which will then give us the ability to start billing for the test.
Meetings are also ongoing with various members of Congress and with the [inaudible] involved in the healthcare veterans affairs immense health issues. We think it's very important to have the support of the [inaudible] and also the agencies to really educate them about the issues that are facing us in abandoning prostate cancer screening, which is what United States Preventive Services Task Force has recommended doing. We think the answer is to screen smarter, use PSA to screen them but then take these men that are at higher risk for prostate cancer and run a test like the 4Kscore test to determine appropriate next step.
As far as potential revenues, they have given no estimate, but I for one do not think 4k will have huge revenue numbers, but they will SLOWLY ramp up. They will have a total of 4 blood tests within a year, and combined I expect ( best guess ) 100m, 50m in the US, 50m over seas. This will also take time to ramp up, the biggest volume test will be D, that will generate the bulk of diagnostic revenues in my opinion.
Welcome, expected at least one, what's an 8 track?
I had to hunt it down but figured it was in the earnings some place? YES some place, last sentence!!!!!!!!!!!!! LOL. BUT now I know where they hide em. I too am waiting on that NEWS, I had my opportunity to bale at a small profit but figured this was a 2015 story, so let it ride, umm not good. That is fine, if we get this Mek back AND the results are good, betting we get taken out. IF not good results, Hoping Astra results nail it. Couple of positive outcomes can happen, all in under 1 year. This is a gamble stock so it is a small position, but want it to do well. I am not adding, or selling, just leaving this one sit for now. News could be any day, I pop out, it will get halted, news pending.
Array BioPharma Inc. submitted an application under Rule 24b-2 requesting
confidential treatment for information it excluded from the Exhibits to a Form 10-K filed
on August 15, 2014.
Based on representations by Array BioPharma Inc. that this information qualifies
as confidential commercial or financial information under the Freedom of Information
Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to
publicly disclose it. Accordingly, excluded information from the following exhibits will
not be released to the public for the time periods specified:
Exhibit 10.52 through August 12, 2017
Exhibit 10.53 through August 12, 2017
For the Commission, by the Division of Corporation Finance, pursuant to
Kevin M. O’Neill
No telling what it is, and I guess Array can choose to disclose this information before 8/12/2017, we will see. My guess and only a guess is it has to do with the Novartis deal. Not saying it is about getting the drug back or not, but that would be the guess.
That said, it is related to this:
10.52 Amendment No. 1 to Drug Discovery Collaboration Agreement, dated November 26, 2013, by and between registrant and Loxo Oncology, Inc.***
10.53 Amendment No. 2 to Drug Discovery Collaboration Agreement, dated April 10, 2014, by and between registrant and Loxo Oncology, Inc.***
The three *** at the end of those items means: *** Confidential treatment of redacted portions of this exhibit has been applied for.
So NO halting, no anything, waiting on Novartis news. This info is from the Aug 15 earnings release.
Yes I have said SEVERAL times I expect 28-32 by EOY 2016, but it gets there in stages, 16, then 32, lol. Amazing how each is a double, umm.
double or triple by late 2015, then gain traction each Q in 2016. The 4k Europe roll out gets followed by South America, then when possible Russia and the Cis countries. We can market Rolapitant in South America Per OUR deal with Tesaro, Rayaldee will GET a GLOBAL market. Revenue by late 2016 should get in the 800M-1Billion range. Rayaldee should take major share from the calcitriol drugs, it will be bigger than most think.
The in office analyzer might be a give away/break even device, but the cards cost under a 1.00. The vitamin D test in OFFICE will be the home run of the in office tests. That is a HUGE market, but not just that, those with ckd need vitamin D tests several times a year. All repeat business marketed alongside Rayaldee to correct D levels. Calcitriol drugs are not the answer, they go the way of the 8 track.
Sell then, good luck with whatever you buy. I will sell this in mid late 2016, but that is my time frame for this to work out. Not every item goes up at once, this is indeed flat for the year, but was up 100% last year. I expect it to double by early 2016, over the next 16 months, but not until revenue starts doubling again, it will happen.
Opko 6 brand new revenue drivers in the next 15 months will easily double revenue, and that is before they gain traction in mid late 2016.
Frost's cost basis is low, he will never sell one share, he has a ton more money to buy shares. His dividends and interest in other holdings FUNDS about 75% of his OPKO buys, lol, he barely touches old money. His Teva dividends are funding a major portion of his buys. I have no idea about other income he has but some items are public knowledge. So he sold Ivax to Teva, and now Teva is helping him take Opko semi-private, Teva, they takeover that keeps on giving.
couple years, float keeps shrinking.
BUY this, put it in IRA, revenue will hit 1 billion by EOY 2016. Quit thinking the size of your wand, 4 inch/minutes, think decade 10 furlongs.
the Dr. thanks you, lol. Pick up a few hundred here is good.
88th of 265 in the med/device sector. Zacks upped it's rating from hold , to buy, with a 2 rating.