So they were in-line with estimates and justifies the current PE. So much for a massive rally.
Qihoo has had an English version of 360Safe, and it is actually very good. Formerly it was easy to download, but for the past 3 weeks it is virtually impossible. The installer is 192MB, and the website has been so slow that it would take at least 6 hours to download the product, which obviously not many will do.
Can't understand why this is occurring.
To me it looks like a pullback to the 9.16 area is indicated (the top of the gap from Sept). Best long play if that happens would be the Nov 9, 11 call spread. This should be available for about 50--60 cents with a possible triple if ramp-up guidance is good.
Most of the 12's were sales. The volume of the Nov 10 contract is higher and those were buys. so looks like most of rge volume was a spread. Yesterday the Nov 10/12 spread was 65 cents. Today 45 cents.
Your better off waiting until everyone and their dog knows about it, then buy, buy, buy at $50.
The FDA will require postmarketing studies of this agent to assess the "known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks," the FDA release said. "These studies will also be required for all other ER/LA opioid analgesics."
It's just not for Zohydro.
Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record-keeping, reporting, and physical security requirements are also in place for these substances.
The FDA will require postmarketing studies of this agent to assess the "known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long-term use beyond 12 weeks," the FDA release said. "These studies will also be required for other ER/LA opioid analgesics."
Safety of this new formulation of hydrocodone is based on clinical studies that have included more than 1100 patients with chronic pain. Efficacy is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed a significant improvement in chronic pain vs placebo.
It will also be part of the ER/LA Opioids Analgesics risk evaluation and mitigation strategy (REMS) approved in 2012. The REMS requires companies to make educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of ER/LA opioids.
The most common adverse effects of this single-entity hydrocodone are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.
In December 2012, FDA's Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2, with 1 abstention, to recommended against approval of this agent for the treatment of moderate to severe chronic pain.
Most panel members voted that the drug had met regulatory requirements for safety and efficacy, as indicated by their responses to questions on efficacy and safety. However, for the last question voted on — "Based on the data presented and discussed today, do the efficacy, safety and risk-benefit profile of Zohydro ER support the approval of this application?" — most had negative responses.
The main concern of those voting against approval was that the potential for abuse of these agents; because the product does not include acetaminophen, they feared the potential for abuse might be even greater.
The US Food and Drug Administration (FDA) has approved the first single-entity extended-release formulation of hydrocodone bitartrate (Zohydro ER, Zogenix Inc) for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.
"Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product," a statement from FDA released today notes.
"Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids."
This formulation belongs to the class of extended-release/long-acting (ER/LA) opioids, the statement notes. "Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," the FDA release said.
It is not approved for as-needed pain relief.
In addition, the labeling approved for this drug conforms to updated labeling requirements for all ER/LA opioids announced by the FDA on September 10 and reported at that time by Medscape Medical News, the first opioid to be labeled in this way, the statement notes.
"The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications," the FDA said. "These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices."
I didn't have the nerve to buy ZGNX prior to today as I really thought the FDA would reject the drug. But what's more amazing is that the stock didn't skyrocket more today. But I couldn't resist and got in a few minutes prior to the close at 3.03. Hope the newswires go crazy this weekend!!!
Sentiment: Strong Buy
Don't know if anyone noticed, but a rather major Call Spread was put on today. So far it is a bit mismatched, but 2100 Jan15 25 calls were bought and 2600 Jan15 30 calls were sold. Net was 1.45 with max gain of 5.00.
In the report, Bank of America noted, “We are upgrading BX to Buy from Neutral given rising distributions and attractive asset growth at a time when some in the sector are likely to begin facing some cyclicality. We are increasing our 2014 DE (distributable earnings) estimate by over 10% given stronger realizations and asset growth, and we are increasing our PO to $28. We view BX as one of the most attractive alternative asset managers given the powerful combination of healthy distributions and solid asset growth. We expect distributions at BX to ramp up over the next 0-18 months, first driven by real estate, then potentially by private equity. Given the sizable amount of seasoned capital, mostly strong current performance, a sizable accrued incentive base, and a favorable exit backdrop, we expect realizations and distributions to ramp up and likely beat expectations over the next 1-2 years.”
Don't get me wrong- I love the stock. If it gets called away I'll pick it up again next week. If not, I've just reduced my cost basis. I also think the stock can double- but not by Friday!!
No surprise. BX has exceeded earnings estimates for the last 2 years. Even if it just matches for the next 4 quarters and reduces its current PE by 50% to a PE of 10 the stock trades at 29 next year. And it has a div of 4%. Upgrade? Duhhhhh...
You really have to know if they went at the Bid or Ask, and also what the Open Interest was prior to the trade to see of it was an Open or a Close of a position. It could have been a Put Spread or a Roll Down. Volume by itself really doesn't tell you very much.
Note that most of the action was in the Sept 9 calls. These were primarily Sells (majority went off at the Bid). The reason for this is simple- It had one of the highest yields (4.1%) for the Sept expiration series, second only to CYS at 5.6%.
Sentiment: Strong Buy
The support level that must hold to make this advance true is about 8-8.05. If you notice the peak from the middle of May and the peak from mid-July were the trading range top. It broke through this at the beginning of Sept, and the bottom was tested and held the next day. So the former top is now the resistance level.
No one should be surprised with the current move. The stock pays a nice dividend which is actually unbelievable if you consider how the company is growing- Earnings last year were 0.30, this year 0.41, projected next year is currently 0.59 (and expect this estimate to be raised). So forward PE at 14 is much less than earnings growth with a 4% dividend.
So it's not surprising that HIMX is at 8.60. It is surprising that it isn't at 10,