Pacira Pharmaceuticals, Inc. (PCRX)

[enchanted]

I dont know why this is falling so badly. The company seems to have a very good potential with exparel.

[surf1944]

bought back into PRCX on the continued drop this morning

[ddls]

Seeking Aplha

Quote: 10/28

I am showing Pacira Pharmaceuticals short interest has increased in recent days to 600,000 shares from 200,000 shares. This is dramatic. The company does not have options for a short seller to position a synthetic long position. I would avoid this stock. The short position is extremely strong and worth noting.


Looks like Seeking Alpha was right!

[Big_R]

You left @ 11.85, thats where you should have shorted it.

What site are you using to see the short interest increasing?

[ddls]

The short interest has been rising. Someone smells dilution. Glad I left at 11.85

[Big_R]

Look @ POZN, Got FDA approved, went to 12.50, just like this one. Guess what......now its 2.50. Good luck

[TradewindsTX]

I just don't get why people would be selling for less than $15 per share so early after approval.

[ddls]

Guess we'll have to wait and see if they can sell this or not. If it catches on with surgeons "and the patients like it", it could be a game changer.

[mlkrborn]

. Pacira grabs FDA nod for post-surgery pain drug Exparel
By Ryan McBride

Pacira Pharmaceuticals ($PCRX) has gained its first big FDA green light for a drug since wrapping a small IPO in February. U.S. regulators approved the company's long-acting bupivacaine product, Exparel, for treating pain after surgeries, the company said this morning.

The company's stock was up just shy of 2% as of 12:30 pm ET today, after the price had surged considerably and then settled down in pre-market trading this morning.

The FDA approval of the Parsippany, NJ-based developer's drug came after a series of successful clinical trials, including a pivotal study in which it was used to treat pain in patients who underwent surgeries to remove hemorrhoids. That study showed that the one dose of the long-acting drug, which is injected at the surgical site, provided significant drops in pain and opioid use for up to 72 hours after the surgeries.

Typically, the product's active ingredient alone, bupivacaine, lasts only about 7 hours when injected after surgeries and then clinicians have to turn to opioids and other remedies to control post-surgical pain, according to the company.

"Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects," Dr. Sonia Ramamoorthy, associate professor of surgery at the University of California, San Diego, said in Pacira's release. "Exparel, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures."

With expected sales of Exparel, Pacira can now bank on revenue from a third marketed product and deliver a key victory to investors who supported the firm's initial public offering back in February. While the difficulty of the market for public debuts in biotech forced the company to significantly reduce its IPO price from a desired $14 to $16 per share down to $7 per share, now those backers who had faith in the company will be rewarded. Exparel is expected to be the No. 1 product for Pacira, which also gets revenue from two marketed products that use its drug-delivery technology. Still, new drug launches have been difficult as of late and are not always home runs for developers.

"This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year," Dave Stack, the company's CEO, said in a statement. "We are excited to launch Exparel in the United States."
SOURCE: FIERCEBIOTECH

[brig]

Which way is this thing going from here

[lady glueck]

so whats the deal with PCRX. what u guys expect she is going to now? chat says hmmpf

[DADDY FAT SAXX]

I bailed at $10.80 after buying in at $9.45. Not at all what I was expecting but profit is profit. On to the next one. GLTA

[Billybob_TX]

Got some 10.25's on the dip.

[ddls]

Hey! Hey!, this was not suppose to happen. It's going the wrong way!

[thegoat]

Must say, I'm a little surprised by the price action. I figured it'd at least flirt with the 52 week high.

Either way, solid approval.

[dav1234]

Yupp low float and high insider holding bodes well,will swing it for a bit

[andrius]

guess since approval was expected it was mostly priced in? had they filled it would have tanked huge. not good risk/reward but never know with these ahead of time.

[surf1944]

Too many biotech stocks have nice up moves into the FDA meeting & then fall on the positive news, but PCRX may still be a buy on weakness sometime today.


surf1944

Share
Thursday, October 27, 2011 3:39:53 PM
Re: surf1944 post# 23
Post # of 154
PCRX approval tomorrow may get the stock price to $15, a no from the FDA could send it to $5, the risk/reward was too great for me, sold out. I usually always sell prior to an FDA meeting, if the stock had a nice run into the event.

[dav1234]

silly huh,shoulda taken 12's and rebought 1 buck lower,lol, cc starts at 9am, guess we wait for analysts and such

[andrius]

don't have a position but man up less than $1 on approval?

[surf1944]

6:30AM Pacira Pharma announces U.S. FDA approval of EXPAREL for postsurgical pain management (PCRX) 10.18 : Co announces that the FDA has approved EXPAREL 1.3% for administration into the surgical site to produce postsurgical analgesia. In a pivotal hemorrhoidectomy trial of EXPAREL compared to placebo, where all patients with inadequate pain control received opioids for rescue pain relief, EXPAREL demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours.

[invest2win]

Yes awesome. Should be a good trading day. Watch the PM Trading!

[spottrader]

nice double dose of news this am. approval and narrower than expected loss.

[invest2win]

Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of EXPAREL™ For Postsurgical Pain Management

PARSIPPANY, N.J., Oct. 31, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX - News) announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL™ (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia. In a pivotal hemorrhoidectomy trial of EXPAREL compared to placebo, where all patients with inadequate pain control received opioids for rescue pain relief, EXPAREL demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours.

"As a non-opioid local analgesic, EXPAREL represents an evolution in the management of postsurgical pain by providing analgesia for several days with a single intraoperative infiltration," said Dave Stack, president and CEO of Pacira Pharmaceuticals, Inc. "This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year. We are excited to launch EXPAREL in the United States."

EXPAREL is an innovative product that combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics, which provide a relatively short duration of efficacy.

"The inability to effectively manage postsurgical pain is a challenge anesthesiologists and surgeons deal with on a daily basis," said Harold Minkowitz, M.D., Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas. "Typically, the first 48 to 72 hours after surgery are the most difficult from a pain management perspective, so a product like EXPAREL, which can provide pain relief with reduced opioid consumption for up to 72 hours, represents a significant, much-needed addition to the currently available postsurgical pain management options."

"This approval is welcome news for surgeons, for whom patient safety, comfort and satisfaction are of primary importance," said Sonia Ramamoorthy, M.D., associate professor of surgery, University of California, San Diego. "Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects. EXPAREL, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures."

Important Safety Information
The safety of EXPAREL has been evaluated in 21 clinical trials, which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was evaluated in 10 randomized, double-blind, clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL. EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. In these studies, the most common adverse reactions (incidence >10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see the full Prescribing Information for more details available at www.EXPAREL.com

Conference Call
As announced previously, Pacira will host its third quarter financial results conference call today, Monday, Oct. 31, 2011 at 9 a.m. ET and management expects to comment further on the FDA approval of EXPAREL. To participate in the live call by telephone, please dial 1-866-831-6272 (domestic) or 1-617-213-8859 (international) and provide the participant passcode 24414196. A telephone replay will be available for two weeks from the date of the live call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), and providing the passcode 74599996.

About Pacira
Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX - News) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL (bupivacaine liposome injectable suspension), was approved for administration into the surgical site to produce postsurgical analgesia by the U.S. Food and Drug Administration in October 2011. EXPAREL and two other commercially available products utilize the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

[wamuer]

cash will be made
the question how much lol!!
see u monday daddy

[DADDY FAT SAXX]

Nice work. I love a good Monday FDA approval. Now if we can just keep the pps up and moving we can make some serious cash.

[wamuer]

no prob my friend lol!!!

[wamuer]

ty bio
respect returned back at ya
take my friend

[invest2win]

Hey ddls, Congrats and happy trading!

[biolover]

U know I person marked u even before this as u r a trustworthy and experienced guy. Lot of respect for u sir!

[ddls]

Thanks Trade,

I'll be eating crow tonight.

[TradewindsTX]

DDLS, that took some guts to share with everyone. Thanks.

There are a number of other good plays to make before the end of the year based on expected FDA decision dates. IMO, one of the most solid is Antares Pharma's (AIS) Anturol (Oxybutinin gel) on December 8. GLTA!

http://www.rttnews.com/CorpInfo/FDACalendar.aspx?Node=B8

[invest2win]

Awesome! Don't forget the person marks! lol!

[ddls]

The great skeptic has to congratulate everyone one holding long and strong. I just relieved an email back from Shelly.

It's been approved.

Here is the official email.

Yes it was approved
Sent from Blackberry

[wamuer]

just found out from shelly burgess too,
drug is approved
thx invest2win for the heads up
congrats everyone

[invest2win]

Bio-runup got the word from me on Twitter. He texted after reading my post.No one else has a confirmation yet other than me. Gekko has contacted the FDA for confirmation but hasn't heard back yet. I haven't heard anything from Adam F thus far this weekend. I'm sure they'll hear something in the AM or the PR will be out by then.

[TradewindsTX]

Excellent post from the PCRX Yahoo Board. Hits the nail square on the head:

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_P/threadview?m=tm&bn=122937&tid=923&mid=966&tof=1&rt=2&frt=2&off=1

"Re: biorunup sent text saying they got approval...     15 minutes ago    
He received the e-mail on Saturday, just a tad bit later after the markets have closed.
How is releasing information on a Saturday when the market is closed an SEC violation if everyone will receive the same info before any trading begins? I can assure you he was not the only one who was given a confirmation of approval. Perhaps you should seek sanctions against the institution that purchased 350k shares within the last 10 minutes of the trading day, I'm sure dropping almost $4 mil coinciding with the approval was purely a coincidence lol.
Dont worry, odds are pre-market trading will be halted monday morning pending co's announcements, then when the gates open you will have plenty of opportunities to cover your short position.
Although I am a bit surprised that a 350k single block purchase order didn't tip you off that somethings up on a stock with an avg vol of 90k PER DAY... Not peculiar one bit ?...

= ) sleep tight"

GLTA! Tomorrow should be one heck of a day.

[JollyGreenSatan]

I'll ask again...is does this 24-hour period include holidays and weekends?

Referring to this:

http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm#updating

check #9:
"How often do you update Drugs@FDA?

We make changes to the database every day, sometimes several times throughout the day. When we are notified that a supplement has been approved, we wait 24 hours to add the information, with the exception of special approvals."

Anyone know?

[biolover]

Now it makes sense what you said. There was some leak either FDA or either company. I don't mind that , as it's good for us LOL

[invest2win]

From the article below:

For the individual as well as the institutional investor, Form T trading does present a few important advantages. If the investor happens to find out something that may have an effect on the price of a stock after hours, they have the convenience of acting on that information immediately. Otherwise, it would be necessary to wait until the markets open again, by which time the information will have reached many more investors, making it harder to profit from the situation. Form T trading also makes buying and selling U.S. stocks more convenient for foreign investors who operate outside the usual hours of trading in the U.S.

http://www.wisegeek.com/what-is-a-form-t.htm

[biolover]

Thanks

[invest2win]

http://www.investopedia.com/terms/f/formt.asp#axzz1cGwq1lJE

[biolover]

How can one find about form T. Thanks buddy

[invest2win]

Did anybody else see the Form "T" buys on Friday just about 4:00. This is also a dead giveaway. Form "T" orders are trades when the market is not open. Why else would anyone not wait until 4:30 unless they knew something we didn't.

Because they knew it was approved and Monday it will open at a higher price.

[invest2win]

That's the same story I got from the original person I talked to at the FDA. Every early word that either Gekko, AF or I received, this list WAS NOT updated until later on.

Those lists are not updated fast enough and it is old news by the they are. I remember someone being in a panic when SPPI was approved about 9PM on a Friday because he kept referring to that list. They are not reliable no matter what they tell you.

[invest2win]

but legally I don't believe that they have done anything wrong.

Obviously they have not being they have been giving out the word for awhile now. Like someone said on YMB. Once the decision is made and the company is notified they can say anything they want but not beforehand. The company obviously knew it was approved on Friday.

I was given the news of a CRL for DRRX and PTIE on a Friday night and Pfizer did not release a PR till Monday in the AM. As a matter of fact I had consulted with Geoff (Gekkowire) and Adam F because I didn't know whether I could release the information to the public beforehand. But there was no way I was not going to let Shareholders lose money by not knowing what was going on till Monday morning.Hence the early morning sell-off pre-market.

The FDA has been releasing early info for awhile now. Anybody who has really been paying attention would know this and not be so skeptical.As far as I can tell Geoff (Gekkowire) has been getting the early word for years.

[invest2win]

Yeah I'm working on it. I don't really have the time or the enthusiasm anymore to keep the site updated. Hey at least I got the word out and most except for the non-believers we able to sleep better last night.

The will find out tomorrow morning and maybe learn not to be so skeptical. May be a little envy there.

[biolover]

Well, i understand what you said. But i am not trusting anybody on the internet, i know invest2win is a reliable poster. he has posted his communication with the fda in his posts. He is asking to check his twitter account to confirm the fda communication. he is not going to benefit now by misleading people. There is a difference between skeptical and ......

GOOD NIGHT

[andrius]

they might have got an approval very late in the day. still need write up the PR, have lawyers look over it, etc. plus most traders are gone for weekend and price can easily be manipulated.

[andrius]

no-one is bashing. everyone should be a little skeptic about posts on internet that appear to be inside information before actual news is out. You can't even trust some of the companies, how can you not question a random poster on a msg board with questionable information?

It is the weekend and news will likely hit before trading starts Monday. Someone misleading now likely couldn't benefit spreading rumors so I would think chances are high FDA did approve. This looks good but don't count the chickens yet. Still need a PR and who knows where this will trade. good luck.