Sell for $30 before you see a PII trial for Oxyntomodulin? No way I say, let the shorts play their games
and let them keep digging themselves a deeper hole. You of course realize that the growth hormone PIII
trial ends on July 12th. OPK will prove that their technology (acquired from Prolor) for extending the half life of proven therapeutic hormones works and Oxyntomodulin is a likely winner. Again a proven hormone that helps with weight loss whose only drawback is its very short half life (6-7 injections per day would be required).
I know its tough to sit here day after day and watch the shorts have their way most of the time, its hugely
frustrating. But we're running a marathon here not a sprint, OPK is a huge winner going forward and the
shorts are going to lose control around here, big time.
OPK paid $480 million for Prolor, if Oxyntomodulin is the real deal as I suspect it is, then it will go
down as the greatest buyout in biotech history. Something else to think about, PFE paid us $290
million upfront for the rights to the growth hormone drug, $300 million more once approved, plus a
nice fat royalty. OPK did exactly ONE phase II trial before they got their deal.
Only 30 days or 1 month to the finish of the part II, PIII, open label trial for our growth hormone drug with PFE. The company will make these results public as quickly as possible because the results will be positive. In fact,
Part II of the PIII trial would have started if Part 1 was not positive. Of course we will have the pediatric results next year and you can add another $1 billion in revenue to the $2 billion for the adult market.
Its been a choppy ride and it would appear that the shorts have gotten the best of us the past two years.
Whilst that may be true, the hole they've dug themselves into to do it is now nearly impossible to get out of.
As Dr Frost always says, they will be buyers of our stock and many shorts will have no idea what the price to buy will be. Sooner or later Wall St is going to start running 2018 / 2019 cash flow numbers for OPK and they
are going to be SHOCKED at how fast this is going to ramp. In FACT, OPK total revenue number in 2019 will likely be more then our entire market cap is today.
The growth hormone drug PIII results, Rayaldee approval, & Oxyntomodulin PI results, & COCP PI results for their Hep A, B, C, D , E, F, G, (obviously kidding but COCP believes their drug will be effective against all
known strains of Hep, 6 at last count) will happen in the 2nd half of 2016. Sit tight longs and don't fret, you've been right as rain all along.
The 2nd half of 2016 will mark the time when the shorts not only lose control the share price but also their
52 days until the 6 month open label part of the PIII trial for the growth hormone drug is complete. The good Dr
has said results are to be expected in the 2nd half of 2016. Something tells me we'll see the results sometime in August. Of course its the exact same hormone used for over 50 years but with an extended half life of one
week. The drug will quickly capture most of the $2 billion US market with the pediatric indication one year
behind and an additional $1 billion in revenue. PFE, upon approval, will pay us $300 million and then an
undisclosed royalty on sales.
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.