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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."
Does this 24 hour period exclude weekends/holidays? They should have stated that if so....
All pdufa plays are going to be volatile going into the pdufa date! Look at the history of any stock that goes into a pdufa date and you will see that. Some trade even crazier like POZN, AVNR, etc.
The reason for the selloff on Thursday was because sheff sold 3/4 of his position to take profits off the table and he has a ton of followers who probably did the same.
Nonetheless, just wait till Monday and you'll see how crazy it is that one can get the yay or nay from the FDA itself before it reaches the public from the company.
Although, I'm not sure I'v heard of the FDA saying 'Not Approved' in an e-mail reply, I feel like most of the e-mail's received back from the FDA have said approved.
A lot of companies do hold it over. For that matter, in today's market, a lot of investors sell (usually not their entire position though)going into a PDUFA date. It's a lot better to have money in the bank with this economy. With that being said, there are also a lot that roll the dice, especially since this had/has a great chance for approval. I think this is pretty normal for a bio PDUFA date, just my opinion though.
Just can't stop and think about the last three days what has happened.
Wednesday the stock moves higher. Thursday the stock moves higher, till midday then sells off. Friday "the day" sell a little then stabilizes.
I would say Mr.Shorty increased his position.
But, why didn't PCRX report an approval if they found out Friday.
Dendreon's date was a Sunday. They issued a PR on the prior Thursday "after the close". That had to have been right after they found out. They also did their CC on the following Monday.
What's the point in holding approval info over til Monday?
You know, it,s funny that you get stuborn bashers all over the IHUB at almost every board. Only thing you can do is to ignore those bashers with poor child hood with bad experiences which they spill all over the community when they become adults.
dude you need to update rockin biotech stocks to reflect the info you pulled! get the word out son! i just sent a linkedin requetst to shelly burgess! whoohoooo!!!
hahaha!
I don't believe that applies here. The FDA is a government regulatory agency and do not have an interest in the stock price of PCRX. I agree, I think that is a bad business practice if they are releasing information before they publish it on their own website, but legally I don't believe that they have done anything wrong.
I personally don't believe it until I see it on the FDA website or see it PR'd from the company. Before anyone asks, I don't believe posted emails either. Someone may in fact talk with someone in the FDA but should prob keep those emails confidential because it only creates controversy.
This could end being a really good investment especially for those that got in around the mid 9's.
http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm
Save it for Monday. EOM
From yesterday
Federal regulators were set to rule today on the new drug. However, the agency typically lets drug makers announce the outcomes of such regulatory reviews.
http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm
You do this same kind of thing on multiple boards however. If the FDA approved then that is good news. Are you trying to prove something by bashing on a weekend? No on is trading we have confirmation if approval but you still keep pissing. Go out to a movie or take your dog for a walk. Better yet go watch some football.
You will get little respect standing and pissing here right now. Usually when people sell they go away.
You sound like a guy with regrets. Wishing you would have bought in but did not.
Good luck to you. You have all Sunday to kee pissing too and Monday morning.
But i dont understand if you sold why should u be so concerned!!!!!!!!!!
Yes I sold, that doesn't mean I can't stick around and see who's right and who's wrong. I'm remembering everyone that has pumped this thing today. Maybe I'll eat crow, maybe they will, we'll see.
GLTY
ddls, how can anyone believe anything you say.
one post says you sold on thursday at 11:85 right near the top
and this post says the suspense is killing you
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68469232
PCRX has their quarterly CC scheduled at 9:00am on Monday, you'll likely have FDA update prior to that call. Posting opinions on what may have taken place, I guess posters have nothing else to do on the weekends.
acira Pharmaceuticals, Inc. Announces Timing for Third Quarter 2011 Financial Results Webcast and Conference Call
PARSIPPANY, N.J., Oct. 24, 2011 /PRNewswire via COMTEX/ --
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that financial results for the company's third quarter ended September 30, 2011 will be released before the market opens on Monday, Oct. 31, 2011. The Pacira management team will host a conference call to discuss the company's financial results and recent and upcoming developments on Monday, Oct. 31, 2011 at 9 a.m. ET. The call can be accessed by dialing 1-866-831-6272 (domestic) or 1-617-213-8859 (international) and providing the passcode 24414196.
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), and providing the passcode 74599996. The replay will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the company's website at www.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-news
So I'm new to this forum and investing in bios in general, but have delt with PR in buisness for some time and from an outsiders view here's my take. The list that has drug approvals for oct 28th is for NDA's (new drug applications). Historically the FDA approves for use about 20-40 drugs a year. However it seems as if they approve applications buy the 1000s per year... (doesn't mean these drugs are going to the market). I haven't yet but someone should research some of those drugs that say approve and see where there at.... As far as this shelly burgess emailing one private investor it seems skeptical. My take on that is.. If you go to eBay and buy a high dollar item your going to check there rating right? If there rating is high and they have sold thousands of products with positive response then your going to feel comfortable with buying from them.. If poeple don't believe invest2wins post do your own DD on him. It appears he moderates on several boards with 1000s of posts..... Credible? Idk that's up to you all.
As far as why the FDA would leak that info my take is that the FDA only needs to keep to themselves until the decision is made, but if asked the need to tell. It's probably the company's PR dept decision to handle it the way they did. Just my thots I have 1000 shares of pcrx so me to am anxious
OK, I did send an email but, it's a day late. Who's going to answer anyway on a Saturday?
Well, this guy seems to be to skeptical. Don't bother keep up great work . We all appreciate it
Like I said 30 times already. They have been answering Gekko, AF and I for awhile. I first got the idea after seeing them answering Gekko on his site. I said to myself why can't I do this. I can send them an email. Obviously it is not illegal. The company has 3 days to issue a PR if I am not mistaken. That is the reply I received what else do you want me to say.
If you are so worried about it why don't you send her an email and ask her or anyone else in public affairs. All the email addresses are on their site.
Why would someone in the FDA risk going to jail for leaking information prior to formally being published?
This was actually the third or forth email I sent. Like I said persistence pays off!
Brian Hall
To shelly.burgess@fda.hhs.gov
Thank you. You are a sweetheart!
Brian
From: Shelly.Burgess@fda.hhs.gov
To: bkhexcel2@live.com
Date: Sat, 29 Oct 2011 08:43:46 -0400
Subject: Re: New Drug Application for EXPAREL(TM)
Approved
Sent from Blackberry
From: Brian Hall [mailto:bkhexcel2@live.com]
Sent: Friday, October 28, 2011 08:43 PM
To: Ventura, Jeffrey; Burgess, Shelly; Walsh, Sandy; Riley, Karen; Liscinsky, Morgan; Jefferson, Erica
Subject: New Drug Application for EXPAREL(TM)
I am inquiring as the the status of Pacira Pharmaceuticals, Inc. PDUFA due today for its New Drug Application for EXPAREL(TM) (Bupivacaine Extended-Release Liposome Injection)
Any info would be greatly appreciated. Please reply one way or another.Thanks!
Brian Hall
http://rockinbiotechstocks.yolasite.com/
Wow, get a clue man
Something reeks of deception on this board.
That why I sold Thursday at 11.85
http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm
hey please please please send me the email with the conformation pcrx has been approved lcastiglione19@yahoo.com i thank you
I am an Investor just like you. Anyone can contact the FDA. Whether they choose to answer you or not is another thing. Believe what you want.
I found out about the PTIE, DRRX, CRL early on a Friday night also. Pfizer did not release a PR till Monday morning.
They have been answering me for a while now. If you are nice and persistent they will answer you. Gekko and Adam F will confirm also if they have not already. I just got back home. I will check it out.
I'm happy with any of those numbers as well. I did a quick flip on my first buy for 5k but with this approval I could be looking at a 10 x return. Glad I jumped back in.
Yeah who knows could open around $20 in the PM then drift to somewhere in the 14-18 range.
Current PT's are:
$20 - Brean Murray Carret & Co - ~100% increase
$18 - Wedbush - ~78% increase
$14 - Piper Jaffary ~38% increase
$17.6 - average - ~73% increase
I'm assuming some of these targets will be increased and also we'll probably see some new coverage as well. I'd be happy even if the lowest target is only reached but I do suspect it will go higher.
I agree. Could go higher too but sometimes you see big selling premarket before the open at the top so it will depend on that as to what the actual open price is. I was happy to get back in below $10 on Friday and to see a small recovery. Worst case we make a few bucks and best case it runs toward $20.
Who are you, how can they tell you the results.
I looked up on net about FDA spokeswoman Shelly Burgess.
Looks ridiculous.
I think $15 is within reason given it was there earlier this year before the pdufa delay.
Someone said $15. I'm good with that. Higher is good too. All depends on premarket. I've see the price rise or drop quickly in premarket after approvals so that will set the trend.
No problem. Any price predictions? Don't worry I won't hold you to it. lol!
To me that last big buy of 350,000 made it obvious. They knew then!
Reloaded at 9.45 yesterday so should be a nice profit Monday. Thanks for the early information.
Yes indeed. Congrats!
Good News!! Should be a nice open Monday. :)
They reply to me, AF or Gekko everytime. I guess since they made the decision they can do what they want.
Yeah it amazes me that they can open their mouth like that but I suspose the company probably told them that they'd announce on Monday Morning and the market isn't open now but still.
OK I'm on it. She is the one he told me about the CRL for PTIE, DRRX
Follow me on Twitter @investor666 if you can and I can send you a copy there!
I'm not a premium message board member so I can't PM but I'll take your word! I suspect the company wanted to wait till Monday Morning on purpose.
I have it! I save all of them. Give me you email in a PM and I'd be happy to send it to you. That goes for anyone here.
At least copy the e-mail you have :)
Once again Shelly Burgess from the FDA informs me EXPAREL(TM) has been Approved
Shelly Burgess from the FDA Informs me EXPAREL(TM) has been approved!
PCRX- Monday it is...
PARSIPPANY, N.J., Oct. 24, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX - News), an emerging specialty pharmaceutical company, today announced that financial results for the company's third quarter ended September 30, 2011 will be released before the market opens on Monday, Oct. 31, 2011. The Pacira management team will host a conference call to discuss the company's financial results and recent and upcoming developments on Monday, Oct. 31, 2011 at 9 a.m. ET. The call can be accessed by dialing 1-866-831-6272 (domestic) or 1-617-213-8859 (international) and providing the passcode 24414196.
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), and providing the passcode 74599996. The replay will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the company's website at www.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
My eyes don't see it on that list.
Bummer Dude!
The 350k share trade at EOD must have been a cover worked thru over days,a straight trade that is more than a few days worth of volume would have spiked the pps,and it didnt budge.
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http://www.pacira.com/index.php
http://finance.yahoo.com/q/h?s=PCRX+Headlines
Pacira Pharmaceuticals, Inc., a pharmaceutical company, engages in the development, commercialization, and manufacture of pharmaceutical products for hospitals and ambulatory surgery centers. It provides its pharmaceutical products based on DepoFoam drug delivery technology. The company's product portfolio consists of EXPAREL, a long-acting bupivacaine product for postsurgical pain management; DepoCyt for the treatment of lymphomatous meningitis; DepoDur for controlling post operative pain; DepoNSAID, which is in preclinical trials for the acute pain; and DepoMethotrexate that is in preclinical trials for the treatment of rheumatoid arthritis oncology. Pacira Pharmaceuticals, Inc. is based in Parsippany, New Jersey.
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