This study info has been out for a while, but sometimes at asco stocks do get a bounce, but this one is overseas,. and they are presenting to endocrinologists, there will be no investment bankers like at asco.
In addition, OPKO's posters to be presented during the conference have been recognized for outstanding advancement by ESPE and will introduce additional data, as well as analytical characteristics of hGH-CTP in preparation for the planned pediatric phase 3 study.
The data to be presented include results from the company's phase 2 trial, a one year dose finding study administering hGH-CTP to growth hormone deficient children once a week using daily hGH as a comparator. The data from this study supported once-weekly dosing for hGH-CTP and also enabled the selection of an appropriate dose to demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study. hGH-CTP demonstrated a good safety and tolerability profile in this ongoing study.
OPKO presentations include the following:
Oral Communication: "Top Line Results of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency (GHD)
Weg: This is what was being referenced in Ireland. It will not have an impact on share price most likely. These things are not attended by analysts, but medical specialists. Nice they Chose an Opko product but, nothing to get TOO worked up over. The Second phase 3 data due next week might give Opk a little pop though, no telling. It ran up a little on first phase 3 data, but I think many thought BOTH studies were done, we will see.
SO About Ireland
Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to be Presented as a Late Breaking Presentation at the European Society of Paediatric Endocrinolog Conference
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), today announced that the abstract "Top Line Results of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency (GHD)" has been selected for late breaking oral presentation at the 53rd Annual Meeting of the European Society of Paediatric Endocrinology (ESPE) on September 20, 2014 in Dublin, Ireland. OPKO will present six month efficacy, safety, pharmacokinetic and pharmacodynamics data from the company's advanced phase 2 trial for its long acting human growth hormone hGH-CTP (MOD-4023) in growth hormone deficient pediatric subjects.Weg: T
I do not have the daily short number, but nasd markets posts them on the 15th and 30th. The short number has barely moved since 6/30, current short number as of 9/15 48.8m, Fund ownership up 10m, to 81.6m, Frost and Jane through various trusts own 185M, shares outstanding 429m. I know there is a difference between shares outstanding and float, but not sure of the actual float. Yahoo lists float as 235m, but I know that is wrong. Ice had the float number, but I cannot find it right now.
Drangles, the catch 22 is they short it, Frost buys many, many more shares. When it comes time to cover, the float has vanished. That is part of the win win for Frost, and why a higher price RIGHT NOW hurts Frost more than helps Frost. He cannot control the shorts, but he can benefit by it, and make them PAY for HANDING him all these cheap shares when he makes a big move, that is HUMOR.
How in the world is Frost loosing the battle? Think about it. He is slowly buying the entire float. If the shorts wanted to hurt Frost the stock would be at 20-30 bucks. The lower it goes the more he accumulates, it is a win win for Frost. The current price action is not something Frost is worried about, he is looking two three years out when the WAR is won. For NOW shorts are helping Frost BIG TIME. Ever notice, he is good at timing his buys TOO, think on that. Small time retail holders are not happy with the recent move, and they can be hurt if they panic, Frost, he has been at this game and knows exactly what is going on with the share manipulation, and loves it.
Sometimes putting the earnings transcript in favorites allows INVESTORS quick access to find things out. My hunch is many never read it, or listened to it, sad to say. Traders VS investors creates that issue.
Sad trader story but I knew a guy who did not even know what a company did, let alone eps.,, earnings date. The CHART LOOKED good though. This guy shorted ticker spln, Some merger news spiked it, That same week he got nailed on vvus his LONG play, which tanked the same time spln ran, maxed out margin, SAD. Eventually lost wife, house, and family would not talk to him. His First move to save his portfolio was to borrow 50k from MOM. He moved out of state.
Talk about the dangers of not using options, or thinking, I'll never get a margin call, ouch.
It is a guess based on the earnings call: We expect to unwind the second identical pivotal trial in September, giving us the required efficacy data to support our forthcoming NDA submission targeted for the end of 2014.
Later Bishop said : And the third gating item is we need sufficient safety data from our ongoing open label extension clinical trial which show that Rayaldee is safe in patients treated for a year and we'll have sufficient safety data from our ongoing extension study by the end of September.
So with regard to the three critical path items, we are fully on schedule for the submission of the NDA by the end of the year. We had previously said that it would be later than this but we've been comfortable now enough to accelerate the announced timing of the NDA submission.
So my Guess is Weds., because if not Weds., it only leaves 4 other possible days in Sept. Many times these type things can get delayed a week or two, to even month to do the stat. work, but he did also say NDA by Dec.,, which is about right, get data 3-4 months file NDA.
It might come to that, but then he owns 1/2 as is. To grow through mergers he needs to stay public, but not once revenue kicks into high gear. He would need do all cash deals then. He bought shares of Zebra and simply handed ( donated ) them to OPKO, rather than use Opko's own cash. Got to like a Ceo like that.
If you notice his buys, he does not chase the shares up, AT ALL. Yesterday Opk had an 18 cent range for example, 8.63-8.45, his buys started at 8.46-8.52, but the bulk in the .47-.49 range, guy is good. He averaged about 8.48, .03 above days low. He loves these sellers.
Now if it were me I would just run it up if I had a spare 3 billion but that's me.
term moves are ALL buying opportunities.
The Rayaldee team knows ckd, LW got it oh so wrong.
Price will follow revenue, so revenue slowly builds with each new product launch, low teens next year, before revenue gets in high gear in 2016. Rayaldee will be bigger than the short side thinks. 400m revenue in first 6 months after approval and they are done here.
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.