Rayaldee side effects? The study listed no side effects. In fact the dosage of Rayaldee can be adjusted up or down to achieve the desired D level. Healthy individuals can just get sun light, or use an otc D to raise levels. Many Ckd stage 3 or 4 patients have this ability compromised.
There is a little confusion about Rayaldee, stage 3, and stage 4. Both stage 3 and stage 4 were ALWAYS the intended market. What they did not know is if stage 3 patients would respond better or at lower doses. They discovered that though stage 4 patients have a more impaired kidney, they responded equally, to similar dose levels as stage 3 patients. So they stated this in a news release and many think this is a NEW patient population that they discovered. What they found out was as long as the kidney still has some functionality, Rayaldee offers an equal benefit, regardless of impairment.
As far as Rayaldee for the general population, it would be fine and safe, but too expensive when otc would do the same.
There is the possibility that Rayaldee might be used in senior care facilities, and they are initiating cancer study.
Well, it did post a small gain last week, in a very weak market. Not sure when it will get to 18, but managing to eek out a small gain with the dow and nas off as much as they were is positive. The market as a whole appears to be out of steam, and opk does not trade in a vacuum, but out performing is a good sign. Now, if opk were to release some positive news, it might start a leg up move. Time will tell.
Though you might think opk is in a position to initiate a dividend, they really are not even close. Opko is still a start up, though a very advanced start up, with a couple late stage drugs, they are still burning through cash. So forget the PFE money, that is needed to advance the pipeline, fund phase studies, buy a small add on company, and is a hedge to doing any secondary offerings. Also it is a one time payment, not regular revenue or earnings. Dividends are paid out of FCF, not seed money, and that pfe deal gave opk a nice chunk of seed money.
Put another way, with the number of shares outstanding, a .05 dividend per quarter would be equal to all of last years revenue, and almost double opk's losses, inside of a .30 per share 2015 loss it would be .50. At .50 that is about 230m, wiping out the pfe money in short order. Opko would need do a secondary by late 2016 as they would be out of cash unless they get a drug approved.
Nice idea, maybe three years from now a .01-.02 dividend could happen, but not in 2015-2016 time frame.
We have taken it so far that we even know that the future sales price of Opk is a multiple of 18, lol, OPKO release some real news, Frost stop buying for a week so we can all babble about quiet periods, if they indeed exist or not.
Have a great weekend all.
I plan to study Pythagoras this weekend, why Pythagoras, well :
Pythagoras, the Greek mathematician who lived from 569-470 B.C., is said by many to be the originator of much of what we call numerology today. The actual origins of numerology predate Pythagoras, the most popular being the very old Hebrew Kabbalah.
but It still sucks.
U ALL know the facts, This has nearly no downside, upside will be a tad slow, but will get over 20 in 24 months, or a tad higher. maybe 22.
I mentioned mack on April 7, was at 12.15, did not buy OF COURSE, up to 13.30, in 9 days, hitting all time high today. Frustrating non buy, lol.
4B buy back is a very tiny percent of float about 2.4%. Though it will help, it is only about 250m share reduction, on over 10B shares.
These are all great points, UMM, otc vitamin d, or some sun exposure is enough for most people. Rayaldee is NOT SUITABLE FOR the masses, it is over the top. Rayaldee is for that 1-2% that cannot metabolize D, but that group is huge.
What I am posting next is old/but related news: In May 2010, we acquired worldwide rights to a novel heparin-derived oligosaccharide which has significant potential in treating asthma and COPD. Over 22 million people in the U.S. live with asthma, including nearly 6 million children. Additionally, there are more than 12 million people in the U.S. who have COPD.
This new news is an ADD on patent, but fits into the Nebulizer deal Oko did about a year ago. I did Email Opk to inform them arry has a phase 3 ready drug waiting a partner, thinking ( nebulizer ) could make arry's drug more potent. Oko does own a novel preclinical ( 8-10) year item, but could prove best in class.
Have yet to see a phase 1 announcement.
Still, Citigroup’s Keith Horowitz and Michael Cronin think Bank of American is worth buying. They explain why:
...but with the stock trading at just above TBV…we think the bar is low and [Bank of America] remains a tactical Buy for us based on our view that the Fed will be raising rates and this will be a preferred vehicle given asset sensitivity and screens cheap.
So basically bac might tread water until the fed raises rates, but accumulating on weakness until that happens, and it will happen, and based on that Citi feels bac is cheap.
tuna, make that statement on the first of each month through Aug, and you will corral Astra news and earnings at a minimum. Make that statement each month from now until mid 2015, you would corner a couple phase 3's and likely a merger. So sooner or later that limb will be safe, not sure about this month.
My take is two weeks prior to info release if you have " secrete " info, and it is then released, but could be longer if a contract is in the works might not be law, but is the standard. Once info is made public, three days before insiders can act.
Sec.gov lists about ten black out issues, under section 306a, So Miami, the real issue is Most/Many have never read the Rules, BUT THEY indeed exist. So on any given day, Opko and Frost could be impacted by sec rules, but Frost not buying is NOT a reason to think he is in a Black Out, but he will follow Sec rules for sure. He did not BUY prior to the PFE news, THAT was material news, a new drug filing, ( Rayaldee ) umm, a grey ( eng) or gray ( US ) not sure it is business as usual, or material. That is UP to the company to decide.
Regarding Frost and Black Out periods, he did refrain while negotiating pfe, cause that was big. On a monthly basis, year in year out he buys and right through earnings. Basically cause there are no surprises afoot. The rest of the Sec rule, or portion I chose:
Rule 10b5-1 provides that a person trades on the basis of material nonpublic information if a trader is "aware" of the material nonpublic information when making the purchase or sale. The rule also sets forth several affirmative defenses or exceptions to liability. The rule permits persons to trade in certain specified circumstances where it is clear that the information they are aware of is not a factor in the decision to trade, such as pursuant to a pre-existing plan, contract, or instruction that was made in good faith.
Rule 10b5-2 clarifies how the misappropriation theory applies to certain non-business relationships. This rule provides that a person receiving confidential information under circumstances specified in the rule would owe a duty of trust or confidence and thus could be liable under the misappropriation theory.
For more information about insider trading, please read Insider Trading—A U.S. Perspective, a speech by staff of the SEC.
Is it really a myth, no it is not. FROM sec.gov:
Illegal insider trading refers generally to buying or selling a security, in breach of a fiduciary duty or other relationship of trust and confidence, while in possession of material, nonpublic information about the security. Insider trading violations may also include "tipping" such information, securities trading by the person "tipped," and securities trading by those who misappropriate such information.
Examples of insider trading cases that have been brought by the SEC are cases against:
Corporate officers, directors, and employees who traded the corporation's securities after learning of significant, confidential corporate developments;
Friends, business associates, family members, and other "tippees" of such officers, directors, and employees, who traded the securities after receiving such information;
Employees of law, banking, brokerage and printing firms who were given such information to provide services to the corporation whose securities they traded;
Government employees who learned of such information because of their employment by the government; and
Other persons who misappropriated, and took advantage of, confidential information from their employers.
Because insider trading undermines investor confidence in the fairness and integrity of the securities markets, the SEC has treated the detection and prosecution of insider trading violations as one of its enforcement priorities.
Black out periods are real indeed.
They did mention during one off the conference calls that they would be submitting comparative data to calcitiol, but my understanding at that time was that info would be submitted after the initial nda. As far as collateral uses, not likely. They are constrained by the parameters of the phase 3 design and what was previously agreed upon with the FDA. Though it seems getting all the statistical data should be simple and fast, it does in fact take a couple months to convert raw data to useable data, and getting everything right takes time. Still, at this point, it is only 2 weeks late so am getting curious as to WHY? From the data presented so far I can not figure why a delay, so I am complaining out loud, lol. Sort of like a watched pot never boils, so I guess if I stop anticipating it will just happen.
It has been two weeks since you announced the note conversion, so do the filing or maybe restate a new filing date. We need something positive to discuss here at Yahoo Central. This lack of news is deafening.
Good luck with the pledge.