Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
interesting read on why this didn't take off...
http://www.thestreet.com/story/10909955/1/cadence-when-a-drug-approval-sinks-stock.html#disqus_thread
CADX 8.08 upgrade 14 dolllars link wedbush
http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm
Thanks.
I was just trying to make people realize that maybe this isn't the huge gapper everyone thinks it will be. I preferred to be long. But after thinking about the 4 most likely scenerios, I realized only 1 would work.
And with THAT large a short interest, I had a feeling something was amiss. I was still unsure of my prediction so I put it out in the open forum, but as the day went on yesterday I became more certain.
The important thing is to learn from what you do.
I've learned many things this week:
MM's will do anything to cause US to lose money rather than them.
What's so obvious may not always really be.
Large short positions are there for a reason.
If it seems to good to be true......
Even if you get the call right, you can still lose.
This all equates into: it's hard to make money. But sometimes not losing is just as big. And realizing a trap can always save your hide.
Good luck to you and all Longs as well. I think LT this drug will still pay off for most people on this forum. ST, may be a little more rocky, though.
Good call here DrChik.
I was right with you on the downside completely outweighing the upside here. This one was too obvious. The only thing that kept me from going in large on a short position was my crappy MerrillEdge account. No shorting stocks below $10. My TOS or Etrade Pro accounts wouldn't have had this problem. Dang, wish there were available funds yesterday in them. Oh well. I did take up a small put position yesterday so that should pay off decent.
Yeah i agree, tomorrow will tell the story, but if there were gains to be made we would be green by now -
I make trades quick sir
That was quick. I think you made a good move. GLTY
Sold at 8.96 - Just barely missed breaking even. Don't like how it's trading and don't want to lose sleep over it tonight. Will buy back tomorrow if the opportunity presents itself.
Good luck to those that hold.
what's the expected gain from approval? the market doesnt' seem to think very high
I wouldn't expect a bear raid after the decision. Most people will have seen the news and readjusted their sell points for tomorrow. Let the shorts buy what they can tonight.
CADX went down to $8.08 after hrs and back up to $9 - what a pickup? Wish I picked up some but did not.
- Raj
You guys are all so silly really. It's like you can only see black and white. Either you're a long or a short. That's ridiculous. I was very confident this would be approved. But with such a large short interest I felt that it would likely either sell on the news, or a bear raid would tell me that it would certainly be approved.
I made logical points based on what could occur and now we're seeing it. AH doesn't mean much, but I don't think you'll see a pop tomorrow. Look at the article I posted and read the portion that says "future commitments"
They have to pay $15million and conduct another trial.
http://www.sys-con.com/node/1595979
I hope anyone with serious money does alright. I have less than $2G in puts and am fine either way. But now you see it's hard to fight the MM's, the big boys.
I'd rather swim with them that sink trying to fight them.
I'm not a short. Not a pumper or basher. I'm a realist. Something this board and others could use more of.
I think we just saw one -
CADX bear raid: Is it possible to have an after hours bear raid?
Shorts could buy back after hours and drag the AH price way down to cover while not setting off any bottom feeding buy orders that are not effective after hours. I'm sure the shorts are looking to get out since they know after AVNR's bear raid people are expecting it.
Any thoughts input on this??
Yeah, it's already back close to EOD pps. The covering should give us a nice pop tomorrow IMO.
Thanks -
I went into this blindly based soley on approval -
Hahaha - sometimes I just get crazy and buy stock..........
Nice buy 8.98 cc call was good. Bouncing back hard
Don't know? Even normal trading today wasn't very impressive but I don't see anything in the PR to account for it. Nice rise in SP about 3 weeks ago but then right back down. GLTY
Well I just doubled down at 8.55 -
Guess we'll see.
Short sellers... They know most only trading it and as they continue to force it down traders bail like they are doing with AVNR right now!
Not to mention the SEC too busy watching porn to enforce short covering
You have enough money you play by a completely different set of rules, the ones you create
Beats me. Tomorrow should be interesting, for better or worse. lol
Yeah, kindoff wish my after hours oder wasn't filled at 9.10 -
Wonder why this isn't green?
By the looks of the AH trading you might be lucky the funds weren't available today.
Look at CADX - $8.88 after FDA Approval. Why is it going down?
Experts - Any good point of entry here? Please provide your TA.
THanks,
Raj
Think tomorrow will be to late to get in? Sold AVNR today and have to wait for funds to clear tomorrow.
Haha!!!! Shorts are going to get burrrrrrrrrrned!!! Yay!!!
congrats to cadx longs.
here's the link to explain royalty payment of $15 million.
read under future commitments:
http://www.sys-con.com/node/1595979
CADX CC call link bottom of page
http://cadx.client.shareholder.com/
FDA approval! booyah
i have to go back and check to see if i'm right about what i say next. (i've researched so many bio's this month i'm looking crosseyed. but for the record i only played avnr big.)
anyway, i think i remember these guys having over 70M in cash, which is good. but i think if drug is approved, they have to pay another company 15 million royalty. this means dilution and cash fears could mute the upward move as well.
Look at avnr. everyone jacked up yr pps targets and stock hit 4.29 today. people aren't buying that dilution won't be necessary sooner, and some are questioning if a company with 20 employees can hire 75 to successfully market a drug that treats a condition many don't know about.
i think they'll come out ahead. with as long a patent as they have, if it fails, they can sell to teva or biogen, for significant premium.
As for cadx, if a bear raid occurs, i think tomorrow is more probable than thursday. these guys did friday for avnr b/c pdufa was set for saturday and two drugs earlier this month found out on saturday.
but i think this is better risk/reward. my heart says long, but my brain says short. my stomach says, i gotta go eat. see you later.
AVNR Nice Article today from Tom Bustamante.
Tom Bustamante, Managing Partner of Ludlow Capital,thinks Avanir is a good buyout target and says pps can top 10.00 soon.. Hold Folks.. HOLD..
GLTA.
The scenario regarding Nov puts is a good one. I would assume there is enough implied volitility no matter what the case, and 75% chance you win (based on the possibility of 4 different outcomes). I like it!
The odds are in your favor!
I was thinking about that precise scenerio and thought I'd run this idea past you guys.
Let's say you buy Nov $7.5 puts for 60 cents. You could buy $2000.00 worth today or tomorrow.
Then, you could set a sell order for $2.00/put, let's say.
If the drug is approved but goes down, due to naked shorting or b/c price is built in, your puts will appreciate.
If a bear raid occurs and drives it below $5, b/c approval is likely, you will catch your $2 price.
If the stock gets approved and shorts haven't had time to cover, your puts are worthless.
And if the drug is denied, then you'll get that $2/put price filled as well.
3 of these scenerios will make you money. What do you think? I think this risk/reward looks better despite thinking the drug will likely be approved?
AVNR: WedBush Raising 2011 Sales Expectations and Price Target to $13 from $9.
http://pics.newsware.com/fc.asp?key=fc_sxb09420&date=2010-11-02
Was on that ride. Had no stops set,thank God.
CADX 8.84 Bullish overview article.Pasted
OFIRMEV’s Europe Track Record, A Good Omen for US Market, Cadence Pharmaceuticals (CADX)) Written by Venkat Nukala
http://www.tapebeat.com/2010100611829/Companies-Profiles/ofirmevs-europe-track-record-a-good-omen-for-us-market-cadence-pharmaceuticals-cadx.html
Tuesday, 05 October 2010 21:59 Cadence Pharmaceuticals Inc’s (NASDAQ: CADX) drug OFIRMEV™ is currently under review at FDA with a new Prescription Drug User Fee Act(PDUFA) action date or FDA approval decision date of November 4, 2010. OFIRMEV™ is an intravenous formulation of acetaminophen that is currently marketed in Europe and approved in many other parts of the world for the treatment of acute pain and fever. OFIRMEV™ received a complete response letter from FDA in February 2010. Cadence stated that "In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA's facility inspection of Cadence's third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval. "
Cadence met with FDA on April 16, which was a Type A meeting held among the FDA, Cadence, and its third party manufacturer to discuss the deficiencies outlined in the Complete Response letter related to an inspection of the facility used to manufacture OFIRMEV. After the meeting Cadence stated "We believe that last week's meeting with FDA was an important step forward to address the observations from the FDA's inspection of our third party manufacturer's facility and move toward potential approval of OFIRMEV," stated Ted Schroeder, President and CEO. "Based upon our discussions with the agency, we believe that it is appropriate to promptly resubmit the NDA for OFIRMEV and intend do so within the next 30 days."
"At the meeting, the FDA did not request any additional information related to the NDA, including any new stability studies. The agency will determine the type of resubmission (Class 1 or Class 2) and resulting review timeline (two months or six months, respectively) after the NDA is resubmitted. Cadence will continue to work with its third party manufacturer to ensure that the observations from the FDA's inspection of the manufacturing facility for OFIRMEV are resolved in a timely manner." The NDA for OFIRMEV was resubmitted on May 4, 2010 and was assigned a new Prescription Drug User Fee Act(PDUFA) action date or FDA approval decision date of November 4, 2010.
Pain Management: Despite major improvements in surgical techniques and the introduction of novel drugs, the overall treatment of post-operative pain has not substantially improved over the last 20 years. According to the industry research group Datamonitor, up to 75% of patients report inadequate pain relief after surgery. Inadequate treatment of pain may lead to a variety of adverse health complications. Only two classes of injectable analgesics are available in the U.S. for the treatment of acute pain, opioids and non-steroidal anti-inflammatory drugs, or NSAIDs. Opioids have been used as analgesics for over 2,000 years and continue to be the mainstay of post-operative pain management. A range of naturally occurring, semi-synthetic and synthetic opioids are available for intravenous use, including morphine, fentanyl, hydromorphone, meperidine, sufentanil, and alfentanil.
Opioids, however, may also be associated with a variety of unwanted side effects when used to treat acute pain, including respiratory depression, excessive sedation, nausea, vomiting, constipation, urinary retention, itchiness, chest wall rigidity, cognitive impairment, and seizures. Respiratory depression may lead to death if not monitored closely. Side effects from opioids have been demonstrated to reduce patients’ quality of life. Opioid use may prolong a patient’s stay in the post-anesthesia care unit or ambulatory surgical facility, as well as a patient’s overall length of stay in the hospital, as a result of opioid side effects and the need to administer additional medications or treatments to resolve opioid side effects. Studies have demonstrated that surgical costs may be increased by opioid use, as a result of costs associated with treating opioid-related side effects, including the potential need for the patient to remain in the hospital for an extended period of time.
The only non-opioid intravenous analgesics currently available in the U.S. are the NSAIDs Toradol (ketorolac tromethamine), a generic form of which is also available in the U.S. from a number of manufacturers, and Caldolor (ibuprofen), which was approved by the FDA in mid-2009 for the treatment of mild to moderate pain in adults, and moderate to severe pain in adults as an adjunct to opioid therapy. Neither of these products are currently indicated for use in pediatric patients. Since NSAIDs do not produce respiratory depression or impair gastrointestinal motility, they are considered to be useful alternatives or adjuncts to opioids for the relief of acute pain. However, the use of NSAIDs is limited in the post-operative period due to their potential to cause increased bleeding. Non-specific NSAIDs, such as ketorolac, block both COX-1 and COX-2, which results in an anti-inflammatory effect but also reduces platelet aggregation and increases gastric irritation, creating the potential for gastric ulcers and bleeding. Additionally, renal toxicity and the potential for increased cardiovascular events further limit the post-operative use of NSAIDs. All NSAIDs carry a boxed warning for a number of side effects. A boxed warning is the strongest type of warning that the FDA can require for a drug and is generally reserved for situations where prescribers should be aware of the potential for adverse drug reactions that can cause serious injury or death.
Status outside of United States of America: Intravenous acetaminophen is marketed by BMS outside of the U.S. and Canada under the brand name Perfalgan. This product is currently approved in approximately 80 countries and is marketed throughout Europe and other parts of the world. Intravenous acetaminophen was launched on a country-by-country basis, beginning in France in 2002, followed by Germany and Spain in 2003, and Italy and the United Kingdom in 2004. Based on 2008 data from IMS Health, Inc., or IMS, an independent marketing research firm, Cadence estimated that more than 400 million doses of intravenous acetaminophen have been distributed since the introduction of this product in Europe, and it has become the market and unit share leader among injectable analgesics, with approximately 90 million units sold, or approximately $250 million in product sales, in 2008. This performance corresponds to an estimated market share in Europe in 2008 of 20% of all injectable analgesic units, and an estimated 45% market share of all injectable analgesic dollar sales. In some European Union, or E.U., countries, such as France and Belgium, intravenous acetaminophen has a unit market share greater than 40% based on 2008 data from IMS. The company believes these and other countries are utilizing intravenous acetaminophen as the foundation for multi-modal analgesia, particularly in the post-operative setting.
Status in United States of America: Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference. Supportive information may also include scientific literature and publicly available information contained in the labeling of other medications. Accordingly, the NDA Cadence submitted for Ofirmev in May 2009 included data from its own clinical trials in the U.S., trials of Ofirmev previously completed by BMS in the U.S. and Europe, and other studies published in the scientific and medical literature. A total of 1,020 adult patients and 355 pediatric patients, consisting of 47 neonates, 64 infants, 171 children and 73 adolescents, received Ofirmev in clinical trials. Cadence stated, it also believes that, prior to the receipt of the complete response letter in February 2010, it had substantially completed labeling discussions with the FDA for Ofirmev. Based upon these discussions, it plans to seek approval for the use of Ofirmev for the management of pain and reduction of fever in adults and children. In the complete response letter, the FDA did not indicate that any additional clinical trials were required in order to approve the NDA for Ofirmev and did not cite any safety or efficacy deficiencies.
The safety of acetaminophen has been well-established through decades of use in oral and suppository formulations. The primary safety concern with acetaminophen is hepatotoxicity, which is a well-understood and dose-dependent effect. Liver failure can occur in people who have taken a substantial overdose of acetaminophen, but it occurs only rarely when acetaminophen is dosed in accordance with the recommended guidelines. In addition, an effective antidote, N-acetylcysteine, is available to treat acetaminophen overdose.
In pharmacokinetic trials, the average peak plasma concentration of acetaminophen was briefly higher for Ofirmev when compared to the same dose of oral acetaminophen, but levels over time were not meaningfully different. These trials also demonstrated that Ofirmev does not accumulate over multiple doses after 12 hours and that urinary elimination of acetaminophen metabolites, including metabolites with potential to interact with the liver, was not meaningfully different for Ofirmev compared to oral acetaminophen at 12 and 24 hour measurements.
With the well established marketing track record throughout Europe(and many parts of the world) for many years and in addition to the pivotal clinical trials, Cadence said, data from the following clinical trials will be included in the re-submitted(May 2010) NDA:
1. Data from Clinical Trials Supporting Safety and the pharmacokinetic profile of Ofirmev in adults
2. Data from Clinical Trials Supporting Safety and Efficacy in Pediatric Patients
3. Data from Clinical trials to demonstrate comparable pharmacokinetics between children and adults
U.S. Market Opportunity: The Company believes that the U.S. market represents a potentially larger sales opportunity for intravenous acetaminophen than Europe with respect to potential unit market share and pricing. The Company estimated that the U.S. market is comparable to the European market when viewed from the perspective of the number of days of analgesic therapy administered to patients annually, which is calculated based on analgesic equivalent doses of the various therapeutic options. Based on sales reported to IMS in 2008, it estimated that analgesic equivalent doses represented approximately 90 million analgesic patient days in the E.U., compared to approximately 80 million patient days in the U.S. The E.U. analgesic therapy market consists of intravenous opioids, NSAIDs and acetaminophen. There are multiple intravenous NSAIDs available in Europe, as well as other intravenous opioids not available in the U.S. According to IMS, 287 million vials of injectable analgesics were sold in the U.S. in 2009. Morphine is the current market leader and accounted for more than 159 million vials sold in 2009. Approximately 90 million vials of other injectable opioids, such as meperidine, hydromorphone and fentanyl, which are all available in generic forms, were sold in 2009. Toradol (ketorolac tromethamine), an NSAID that is available as a generic drug, and Caldolor (ibuprofen), another NSAID, are the only non-opioid intravenous injectable analgesics available for treating acute pain in adults in the U.S. According to IMS, more than 38 million vials of injectable ketorolac were sold in the U.S. in 2009.
On average, pharmaceutical pricing continues to be higher in the U.S. than in Europe. According to IMS, the average selling price in Europe in 2008 was approximately $2.85 (U.S. dollars) per vial of Perfalgan, or intravenous acetaminophen. Cadence believes the unit price of Perfalgan in major European countries was largely driven by government-controlled reference pricing in those markets. In Scandinavian countries with less restrictive pricing controls, the average Perfalgan selling price is as high as $10.42 (U.S. dollars) per vial. The price of ketorolac in the U.S. in 1997, prior to the entry of generic competitors, was approximately $7.00 (U.S. dollars) per vial, according to the American Journal of Health-System Pharmacy. The price of Caldolor in the U.S. was $10.50 (U.S. dollars) per 800 mg vial at launch in 2009.
The Company believes that, upon the approval of OFIRMEV in the U.S., the key product attributes that will drive the adoption of this product candidate include the efficacy and safety profile of Ofirmev demonstrated in multiple clinical studies, the excellent safety profile and familiarity physicians have with oral acetaminophen, alone and in combination with opioids, the potential for reducing concomitant use of morphine and other opioids, the need for a more convenient dosage form for patients unable to take mediation orally, and a more rapid onset of action. In a market survey by IMS in 2007, 81% of the 126 U.S. physicians surveyed indicated readiness to use Ofirmev immediately following the product’s approval by the FDA.
Wedbush recently rated an Outperform on shares of Cadence Pharmaceuticals. The firm notes that "if approved, OFIRMEV would be the only injectable non-opioid, non-NSAID pain product available in the US." Wedbush points out that the current post-operative pain market in the US is dominated by injectable opioids, specifically morphine, and that these products obviously carry significant side effects. The firm believes that OFIRMEV could launch in Q1 of next year and reach full year profitability in 2013 with peak gross revs of $465 million in 2015.
Cadence Pharmaceuticals is among the companies in the Pharmaceuticals industry with the highest short interest ratio, which is 44.5 based on average daily volume of 193,000 shares and 8.6 million shares short. That equates to 17% of the 50.6 million shares outstanding. Insiders hold more than 50% of the shares, while Institutional & Mutual Fund Owners hold the major chunk of the remaining shares. With such a low float and high short interest the price can spike with momentum going close to the FDA decision date of November 4th 2010.
--------------------------------------------------------------------------------
Disclosure: Venkat Nukala has a long position
--------------------------------------------------------------------------------
Disclaimer: This article is an expression of an opinion on a particular company or matter. TapeBeat.com or the author(s) of the article(s) is (are) not a financial advisor(s) or professional analyst(s). This is not a solicitation to trade any security. Although the author relies on company approved public documents and makes all reasonable efforts to confirm the accuracy of author's statements, the comments made in the articles should be considered only as opinion and should not be considered as current or as absolute fact. All investors are strongly encouraged to not rely entirely on any single opinion and perform their own due diligence when investing. Investing in equities includes considerable risk, and investors should be prepared for the risk of capital loss.
DrChik23, you are right on here. The benefit is clearly not worth the risk. We're not talking oncology or a specialty drug treating a condition for the first time (e.g. AVNR - and even that didn't run as hard as we all thought). This is IV Tylenol.
Based on the odds alone, I will be short the stock or wait for a buying opportunity after the news. I actually think they do get approved, I just don't think the upside will be great and it's more likely this drops.
stop losses no doubt assisted the bear raid on avnr, maybe holders of cadx are on to what happened there and we are less likely to see it here.
i have bought a few- not having a bear raid will hopefully mean the shorts dont get a chance to cover lower and means we end up a with a higher price post -approval due to a squeeze.
thats my theory anyway- i have set some buys lower just in case, which i am sure i will profit on approval, the buy up here not as sure if indeed we have a raid.
i think many of the folks who saw what happened on avnr also have buys in lower so this will mean more support here.
guess we will have to wait and see
GL!
This is a tough one to figure. With AVNR, I was certain approval would occur. Despite the shorts, I knew that if they followed SPA protocol, they would be approved. (Others had doubts, but most criticism was truly unfounded if you did your DD).
Anyway, CADX is another story. It seems like there is little doubt that the drug is safe and effective. Despite some earlier studies that did not help their cause, this drug has been used for quite some time in Europe already.
So the real hold up has been the manufacturing? This is a little suspect to me. So is the fact that this is more heavily shorted than AVNR. With AVNR, I didn't care if it dropped from $3, because the drop couldn't be that bad. (OK BIOD fans, I know you'll disagree, but follow me here for a second.)
If this drug gets knocked down, where will IT go? VERY far down.
Now, I'm like most here, in that I feel that it WILL get approved. But the risk/reward is not that great. Here's what happens. Shorts find out that this is gonna get rejected and this stock goes to the $3's for sure.
They find that appproval is likely and they do the same bear raid that AVNR received. If you set a buy at $4 or $5, it may get filled on the way down if the drug gets rejected. And if a bear raid occurs, there's no guarantee that it gets filled on the way down, but probably will get filled on the slower way back up.
The safest way to play, I think, is to wait, watch and see. If it tanks on NO NEWS, then start buying when price begins to recover from drop. You'll make less profit but still significant money. And if it doesn't happen, don't worry. You haven't lost much.
I would have bet thousands that AVNR would be at $10, with the amount of shorts that existed two days before the PDUFA date, 26% of float. And the shorts took care of that. Also, how is the short ratio 56% of float when there is less than 10 million short and over 22 million shares float?
Scenerios:
Drug denied: we lose big
Drug delayed: we lose
Drug approved: we gain (but not likely as big as you think as bear raid eliminates many shorts)
You don't have to play it safe. Just play it smart. The similarities to AVNR are there, but that doesn't mean the result will be the same. I hope it does get approved. It seems like a valuable drug with an appropriate niche. But risk/reward is sometimes more important than being right.
Mega-short here. We know they won't go into a likely approval without a fight.
Paste CADX 9.05 shortsqueeze 56% of float is short that is alot of buying power.
http://finance.yahoo.com/q/ks?s=CADX+Key+Statistics
Trading Information
Stock Price History
Beta: 1.53
52-Week Change3: -1.66%
S&P500 52-Week Change3: 14.19%
52-Week High (Jan 7, 2010)3: 10.91
52-Week Low (Jun 23, 2010)3: 6.29
50-Day Moving Average3: 8.70
200-Day Moving Average3: 8.18
Share Statistics
Avg Vol (3 month)3: 261,135
Avg Vol (10 day)3: 436,656
Shares Outstanding5: 50.56M
Float: 22.84M
% Held by Insiders6: 56.10%
% Held by Institutions6: 44.50%
Shares Short (as of Oct 15, 2010)3: 9.77M
Short Ratio (as of Oct 15, 2010)3: 29.30
Short % of Float (as of Oct 15, 2010)3: 56.00%
Shares Short (prior month)3: 8.95M
Sheff just bought some 9.14 link . I bought the nov. 10 calls glta
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56154439
It's a shame it's like that now, but gotta roll with the punches I guess. I believe it will be approved this week; however, I'm not buying until the last minute. This will avoid me buying, then living through ANOTHER bear raid. If they raid, I'll be waiting this time. Good luck to you.
Thanx HOG - Gotta adapt to the new tactics the mm's are deploying.
We'll see what happens.
Are you in this one?
Best of Wealth!
Hello all! Took some profits from the AVNR play and put in a buy for CADX @$4.70 in case of the same 'flash crash' that both POZN and AVNR survived.
If you can't beat 'em... ;)
Best of Wealth!
Followers
|
8
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
131
|
Created
|
10/14/07
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |