Anyone surprised by the latest selloff hasn't been around here long enough. These selloffs in the past have
proven to be very good buying opportunities. The story is quite intact here and this latest addition to the GIG family brings some serious revenue with it. Avi has proven to be a very smart buyer of companies that fit
seamlessly into the product line and this new one looks really interesting.
The manufacturing problems will be corrected, new procedures will be implemented and the staff will be
trained. If the manufacturing issues are corrected quickly, the launch will not be delayed by much. The
key part of the FDA decision was the labeling, insert and packaging part are done and agreed upon. OPK can begin the process of getting all that ready to go to the printer. T
Yup, mistakes were made but you have to like the corrective action. 16 + years
at PFE and most recently at Allergen. I'm not a perfection guy but when you mess
up you get it fixed. I'd say OPK made the move to get it fixed.
I'm going to trust my money with Dr Frost, they have a problem and they will fix it. I'm not happy but
what is done is done. Look at the bio on Dr Trust, trust me, he will get it fixed.
This is how Dr Frost responds to a setback, he goes out and hires someone with enormous experience to
address the issue. He obviously couldn't talk about what was going on, when dealing with the FDA, you say
NOTHING publicly and he knows this. What he could do was go out and hire one of the best and brightest.
It should not be lost on anyone that DR Trust's hiring announcement was on March 28th, OPK obviously
knew there were issues. Believe me, when you are going through an FDA audit and you have faulty or
missing log books, or not logging at all, scale log & calibration issues, ect ect, you KNOW you have a
problem. This is basic stuff folks that should not have gotten by OPK. Dr Trust will be fixing whatever needs
fixing at OPK and at our contact manufacturer.
GIG usually goes down after earnings. Guidance will be key, can Avi turbo charge revenue and earnings with this recent addition? They seem to be in the perfect markets ripe for growth so you have to like this stock going
Its not an easy job and politics always creep into things when dealing with a Fed agency. The name of the game is cover your #$%$ cause its your #$%$ on the line if something goes wrong. The GMP issue was serious
enough to cause the delay so its a big deal and someone should have caught it before the FDA got there. I
guarantee you OPK had QA people there doing their own audit so there is no excuse, someone missed
Having said that, people who have not worked @ a Pharma company have no idea what goes into adhering
to FDA drug manufacturing rules. The documentation alone for manufacturing one lot of a drug would boggle your mind, For good reason too, people can die if you don't get it right every single time.
While disappointed with the approval delay, this won't affect things much if the "issues" the FDA had can be
corrected quickly. Having conducted GMP audits at contact packagers for a big pharma in a past life, a
trained eye can always find stuff that needs correcting. The FDA folks are a different breed and they have
a tremendous amount of power when they walk into your building. Its difficult to explain but its almost like
you are not in America when dealing with these folks, probably closer to being in Russia or China (without the bribes of course). If you are smart you keep your mouth shut and do what the F they say. Very, very, few
companies publicly take on the FDA. AMRN recently won a big case against the FDA but me thinks they will pay a steep price for that victory down the road.
The good news is that OPK can begin getting the packaging and insets ready for production so Rayaldee might
not even be delayed as far as getting to market is concerned.
The stock is down a nickel and we've traded almost 5 million shares already. The shorts must be throwing
everything they have at this and someone (s) is grabbing every share,
The good Dr. has not bought a share since 3/16 so I'm assuming he has news that he can't trade on. It
obviously could be that he already "knows" that Rayaldee is approved OR OPK is in discussions with PFE
ironing out the deal. Imagine for a moment OPK announces the approval of Rayaldee and then an hour later announces the deal with PFE, that would be poetic justice in my book.
Wall St. pays up for revenue growth, no matter the business. While OPK will obviously not grow their revs
to infinity we are looking at double digit growth for years and years to come. Rayaldee represents another
source of income in an ever increasing product portfolio. While the 4k. bio ref labs and Rayaldee revenues continue to grow through 2017, in 2018, the growth hormone drug with PFE researches the market. Anyone
familiar with the OPK / PFE agreement understands that royalties start once FDA approval is given, not only
on our drug but PFE's existing drug which I believe does $900 million. No matter, OPK / PFE will capture
most of the $2 billion US market. The Hemophilia drug will be ready in 2019 and then, after all this, the
granddaddy of them all OXYNTOMODULIN.
Keep in mind this is just what we know about as of today, who knows what the good Dr will buy once the cash
starts flowing. Also, OPK is not set up for global marketing, big pharma has the cash and the infrastructure to handle this for us, more cash up front, more royalties. The cash flow $'s for OPK will be off the charts, royalties
are sources of income with expenses already paid for, they go straight to the bottom line. The fun starts
around here once PFE signs up a ROW marketing for Rayaldee so don't be concerned if the stock price
doesn't go crazy on approval.
Nothing the shorts say or do can stop this freight train from running them over, stay long and relax, you have
a winner for the next decade.
Good heavens, either the author is a complete FOOL or he has some other motive. As Burnaka pointed out,
Amgen's drug is for stage 5 which is DIFFERENT from Stage 3 & 4. Pill vs injection? It would have been no contest anyway. What the motley FOOL author does not explain is that diabetics have compromised kidney and in many cases liver function. Popping an OTC vitamin D is NOT the answer for them, it can actually make them sicker. Rayaldee is a winner and it will be quite profitable for the company for many years and many
more indications to come..
Even the premise that OPK is risky is ambiguous at best. Where is the risk, that insurers might not cover the
4K, really? They would rather pay for the biopsy and pray the patients doesn't get MRS or some other
complication. Insurers would rather pay the extra couple thousand dollars and take the risk of complications,
instead of paying for a simple blood test, really? Rayaldee won't sell in a market with no competition and
millions upon millions of potential customers, really? Where is the risk in the growth hormone drug? There is no risk, its the exact same growth hormone that's been in the market for 50 years, OPK's hormone is just
If you read this article and didn't really know much about the company and who runs it, you'd believe the
author knew #$%$ he was talking about. He doesn't, this is another GARBAGE piece from the FOOLS. These
hit pieces always seem to come after the stock has a nice run up, coincidence? I don't think so.
Oxyntomodulin / Rayaldee, the one two punch for the shorts. We have them on their heels, leaning up against the ropes, the knockout blow comes on the ROW marketing deal. They do have a window to get out, but its
closing rapidly. You have to believe we have been having strong institutional buying this Q so who knows how
many shares the shorts have available to cover. I'll tell you one thing, they won't get one bloody share of mine.
Vitamin D deficiency in diabetics causes a cascade of adverse health events most having to do with excessive inflammation in the body (on top of their diabetic issues). For those who may not know, vitamin D is what the body uses to fight inflammation. Preventing a patient who is in stage 3-4 from going to stage 5 will save the medical system billions and billions of dollars. Improving the health of these stage 3-4 patients will also save the system billions and billions of dollars. Rayaldee will be a huge winner for the company and this is only the first indication. Wall St still doesn't understand but they will when that announcement comes on some Monday in April or May letting us know PFE is our ROW marketing partner.
BTW, the people who developed Rayaldee still work at OPK three years after the buyout.
Not sure why you waited until $10 + when they were just under $8. Of course, in 5 years, it won't matter where you bought as long as you bought. Now you will be on the right side of history. Why the change of heart?
IMHO, PFE will be our global partner for Rayaldee. OPK would be stretched way too thin to file for
approval, hire and train a sales force in Asia, Europe and SA. PFE has the infrastructure to do this
seamlessly. They also have plenty of cash to give for the marketing rights. I don't think Dr Frost will
wait long after Rayaldee approval to make a deal.
You have sided with one of the smartest business minds in biotech who has surrounded himself with people
who are even smarter then he is. OPK is the cumulation of everything Dr Frost has learned along the way in
his hugely successful career. His vision is coming together right before our eyes and all the pieces are coming
together perfectly in sync.
If Dr Frost pulls the trigger on a ROW marketing deal for Rayaldee, forget about it, Wall St will come piling in and piling on the shorts. I believe its coming and PFE is my pony. Once US approval is granted let the talks
begin. Imagine being short on some Monday morning in April or May when the news breaks before the
open? $19? the shorts will be dreaming about that # as they look back at it in their rearview mirror.
OPK's plan is to have their Multi Use Auto Injector ready by the time the hGH drug is available for sale in
early 2018. Along with suppling the raw materials to make their drugs and getting a piece of that, OPK will
also get a piece of the delivery market. I'm assuming the plan is for all the biologic drugs to come already
preloaded in the injector. Its guaranteed to be successful because we KNOW that the hGH drug will capture most of the $2 billion market. The pediatric indication is $1 billion and will be in the market by 2018. The
hemophilia drug and Oxyntomodulin could also come preloaded in the auto injectors. No doubt syringes will
be a thing of the past. Imagine going to the beach and not have to worry about stepping on a syringe?
Obviously OPK is not the only game in town but if your drug comes preloaded, the consumer has to use it.
This area is not discussed much by OPK but it just gives you an idea of how the good Dr operates. I can't
figure out how someone looks at OPK and decides this is a great company to short.
PI trial announcement in the 1st Q so might it might as well be @ the Barclay's conference. Is it unreasonable to estimate the global market potential for Oxyntomodulin @ $25 billion? Its still 5 years away but the good Dr. knows exactly what he has. The hormone and its ability to help you feel full have never in been in question, it was always the problem of the half life. Its estimated that you'd need between 4 to 6 injections daily for it to be effective, the OPK / Prolor technology extends the half life to a once a week injection. That folks is something
to be very excited about. Its really no different then our growth hormone drug, extend the half life of a known and proven hormone to a once a week injection and bag PFE to capture the entire market for you, easy cheesy.
Me thinks the good Dr is holding onto Oxyntomodulin, the ROW Rayaldee deal (Apr or May) will pay for the
entire regulatory process and the buildout of a global salesforce to market it.