OPKO Submits Investigational New Drug Application to Initiate a Phase 2a Trial for its Long-Acting Coagulation Factor VIIa-CTP to Treat Hemophilia
OPKO Health, Inc. (NYSE:OPK) announced the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2a study of OPKO's long-acting version of coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.
Factor VIIa-CTP is a novel, long-acting recombinant Factor VIIa utilizing OPKO’s proprietary technology to extend its circulatory half-life without the use of polymers, encapsulation techniques, or nanoparticles. The technology is based on a naturally occurring peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin. The CTP technology is also used in OPKO’s hGH-CTP, its long-acting recombinant human growth hormone product which is being evaluated in Phase 3 clinical trials for adults and Phase 2 trials for children with growth hormone deficiencies. OPKO recently announced a global agreement with Pfizer for the development and commercialization of hGH-CTP.
Currently, Factor VIIa therapy is available only as an intravenous (IV) formulation which, due to Factor VIIa’s short half-life, requires multiple infusions to treat a bleeding episode. In addition, frequent infusions are onerous when used as preventative prophylactic therapy, especially for children.
Pre-clinical studies of intravenous and subcutaneous formulations of our product in hemophilic animal models demonstrated its duration of action and significantly increased survival.
“We look forward to beginning clinical trials of Factor VIIa-CTP,” stated Phillip Frost, M.D., Chairman and CEO of OPKO Health. “A longer acting Factor VII administered either by IV or subcutaneous administration, could change the Factor VIIa market by permitting children and adu
You know.......one might interpret that terse response as being sarcasm. When I was working for other people, it was always in a role of helping other people. Something in my wiring I guess. And so, if that was sarcasm, maybe you are not quite the ___________ you try to appear to be. OTOH, if you actually meant what you said (I am no longer working for other people for a reason), then you kinda got me. Good for you; and bad for you.
Main thing is, long ago, I learned not to listen to what people said, but to look at what people do. Hard to do on these anonymous message boards. So, the jury is out on you, which is why you are not consigned (yet) to my ignore bin. You could say I'm still trying to figure you out. Not that I care what you think, or do; I just don't trashcan somebody unless I am convinced they are trash.
You could, if you wanted to, lose that biased moniker. You could, if you wanted to, come clean and say you were disappointed in past pps performance (or any other honest declaration of your choosing). You have to admit it is not accurate anymore.
Well, whatever, join the right side, stick by virtue of your screen name with the wrong side. In the end, it doesn't impact my position in this juggernaut of a company. Not anymore than any other trash talker impacts the pps. Have a good night and a better tomorrow.
Possibly has to do with the intended use of the funds raised:
"The Company anticipates using the net proceeds of the offering (i) to complete the TIARA-I Feasibility Study; (ii) to initiate a U.S. Investigational Device Exemption Study for Tiara; (iii) to further develop and refine Tiara; (iv) to advance the commercialization of Reducer in Europe; (v) to initiate a U.S. Investigational Device Exemption Study for Reducer; and (vi) for general corporate purposes."
Or the fact they increased the offering size "due to market interest." Which market interest seems to be the case as indicated by the volume. Not to mention a new all-time high at $9.30.
It's still 3 days, but it's a money thing. IE, you can just pony up money to cover the deficiency, or sell other stock, else you or they buy to cover (which of course, would probably still leave a balance owed).
I spent a couple years looking for a pattern. There is no pattern that I can find. Due to the regularity of his buying, one would be hard pressed to make a case against him for trading on non-public knowledge. As for the mythical "quiet period" or whatever one wants to call it, he bought yesterday and today the PR seems to have had some influence on the stock price. So, obviously, there is no such thing.
Some have suggested he has filed a 10b plan where his buys are scheduled. Due to the wide variance in the size of his purchases (5K one time, 400K another time, 45k another time) and those periods where he skips a week or a month, how in the world could that be pre-scheduled?
Nope, as I see it, having recorded every transaction since the inception of OPK, there is no pattern, and he buys as much and whenever he sees fit. If one had to characterize his buying, give it a name, "dollar-cost averaging" would fill the bill.
Yesterday you did a "I told you so" post on this very subject. Now you're still banging the same drum? Which is it.......it happened or it's going to happen? If you say the same thing everyday, I'd be willing to bet, sooner or later, you'll be right. But that thing about buying more under 10? Might want to revise that part.
In candlestick charting, that is known as "the market is 7/8ths full." Pauses or backfill comes after 3, 4, or 7 new high closes.
Those orientals.......very clever. And much older in terms of experience than Western markets. They were trading rice futures before we knew what rice was.
Well, you know very well how the bashers will respond (if they actually are that crazy). If OPK says it's good, it's the "placebo effect." And if PFE says it's good, well they are desperate to offset their expiring exclusives.
And if you say it's good, or I say it's good, we are "bag holders" just hoping to get even. LOL.
To which I would say, "if one would grab the Tiger by the tail, one would best have a plan to deal with the teeth."
Oh, something is coming, and the shorts won't like it, but the chatter about Frost not buying being indicative of anything other than that he didn't buy is just grasping at straws. (Kinda like the notion he is taking it private).
You're right. Not significant. He skipped the entire month of Jan '09. Also all of Sep '09. And all of Oct '11. All of Aug '13.