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EXEL..$5.77 A new peer-reviewed article demonstrates reduction of tumor invasiveness & metastasis in preclin pancreatic cancer. Interesting data here in a hard to treat tumor.
http://bit.ly/ylEewN
TLON..$.93 Key information from their 2010 ASCO presentation from their RALLY study. The data is far from "underwhelming" and is very impressive. This is in 3rd-6th line patients who had already been on regular vincristine. The results are significant in a disease with few options. This is why the FDA granted "accelerated approval." Accelerated meaning conditional approval with Phase II instead of Phase III data and not standard review to priority review. Priority review meant nothing to Talon if they could not get the confirmatory studies up and running in time. The extra 4 months (standard review) has given them time to get their studies in place. Still waiting on a pt to be enrolled in the HALLMARQ conf Phase III study. Standard review was best for Talon.
The FDA also gave them a SPA for their confirmatory Phase III study understanding that if they approved them on single trial Phase II data that the company would have sufficient time to demonstrate that their durable response would translate into a meaningful clinical benefit (i.e. increased survival advantage). This was the 56 pt study as the data has been updated to include the 65 pt study as well. Still solid data.
TLON..$.93 The company's recent financing of the 11m can only be satisfied if the company increased the A/S. There are shares that need to be converted at .30 from that deal eventually. The company had to increase the A/S. The deal is with Deerfield. That is the least of an investor's worry right now. What is on my mind is making sure the company has dotted the I's and crossed the T's with the upcoming AdCom Panel.
do you have a link for this calender?
TLON what do you thinking about raising A/S and the last 8K filling
from tlon board
ErnieBilco Member Profile ErnieBilco Member Level
Share
Sunday, February 26, 2012 10:07:28 AM
Re: None
Post # of 2040
Appears they are getting their golden parachutes ready for a take over..... by the looks of the Feb 24th 8K.
I'm not happy that they were paid milestone bonuses for only hitting 40% of their milestone targets......... what does their base salary "compensate" for? Just showing up for work?
http://www.otcmarkets.com/edgar/GetFilingPdf?FilingID=8436937
OT: FDA Panel Calendar
Stocks that have PDUFA decisions in March and one key stock with advisory committee meeting!
Date:02/26/2012
Company:Columbia Laboratories, Inc.
Ticker:CBRX
Drug:PROCHIEVE
Event:PDUFA 2/26/12 of PROCHIEVE for reduction of risk of preterm birth.
Date:03/06/2012
Company:Astex Pharmaceuticals, Inc.
Ticker:ASTX
Drug:Dacogen
Event:PDUFA 3/6/12 of sNDA of Dacogen for Acute myeloid leukemia (AML)
Date:03/06/2012
Company:Discovery Laboratories, Inc.
Ticker:DSCO
Drug:Surfaxin
Event:PDUFA 3/6/12 of Surfaxin for Respiratory Distress Syndrome
Date: 03/07/2012
Company:NeurogesX, Inc.
Ticker:NGSX
Drug:Qutenza
Event:PDUFA 3/7/12 of Qutenza for Neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)
Date:03/21/2012
Company:TALON THERAPEUTICS
Ticker:TLON
Drug:Marqibo
Event:Advisory Committee Meeting March 21, 2012 for Marqibo in patients with Philadelphia chromosome-negative acute lymphoblastic leukemia
Date:03/26/2012
Company:MAP Pharmaceuticals, Inc.
Ticker:MAPP
Drug:Levadex
Event:PDUFA 3/26/12 of LEVADEX for Migraine
Date:03/27/2012
Company:Affymax, Inc.
Ticker:AFFY
Drug:Peginestide
Event:PDUFA 3/27/2012 of Peginesatide for Anemia in chronic renal failure (CRF)
Date:03/28/2012
Company:Chelsea Therapeutics Internatio
Ticker:CHTP
Drug:Northera
Event:PDUFA 3/28/2012 of Northera for Neurogenic Orthostatic Hypotension
Investor 100
$GTXI -
Ostarine is the breadwinner....
http://www.bizjournals.com/memphis/news/2012/01/30/gtx-inc-shares-soar-after-citigroup.html
Link to cc from Feb 21rst:
http://edge.media-server.com/m/p/6xx8e375/lan/en
Pipeline:
http://www.gtxinc.com/Pipeline/Overview.aspx?Sid=1
Big opportunity here on the FDA hold on Capesaris clinical hold selloff imo!
http://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120221005753&newsLang=en
ECYT
this is probably old news, but havent seen it on the board.
Seems like a solid entry point!
European Medical Society
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/02/human_orphan_001023.jsp&mid=WC0b01ac058001d12b&murl=menus/medicines/medicines.jsp&jsenabled=true
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/02/human_orphan_001023.jsp&mid=WC0b01ac058001d12b&murl=menus/medicines/medicines.jsp&jsenabled=true
http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2012/02/WC500123294.pdf
gl
Credit goes to Pmony for that QCOR idea...I just did a little DD and spread the word. Due to the 17 percent short interest, I was afraid shorts would revisit the stock after the earnings pop. Therefore, I sold half after hours on the earnings pop and the remainder the next day...I ended up with +6.4% and +12%, although QCOR kept moving and by today it got to $39.80, which would be about +18% from the $33 low range near the end of last week.
TLON..$.935 Will be revisiting this one as well this weekend and posting some good information (article from Nov 2011) I came across on "accelerated approvals". Really strong in favor of what TLON is doing during this FDA process. Whether they enroll a patient on the Phase III conf study is important. I think it adds "icing" to the cake. Even without that, the study has been initiated. The FDA has indicated they want to see patient enrollment at the time of approval (5/13) so that would be the most important thing for the company.
RGEN..$4.25 Going to do a solid DD post here this weekend on this one. Should turn out to be a strong performer in the near-term based on what I have found thus far. Love the priority review on this one! That is absolutely big for these biotech companies as few are granted this designation. That also goes for "accelelerated approval" designation.
Correct and very interesting your accounts and not difficult to do that!The reason i believe could go higher than $14, good luck to all in!
VVUS..$21.90 What a hugh bounce today up over $3. A lot of covering today for sure.
AFFY..$10.41 There are around 22 more trading days until the FDA decides (March 27th). If it goes up and avg of .10 cents per day over that period then it will be pushing $13 pre-pdufa. I see no reason why it cannot be done. It has a low market cap here imo.
i don't know if there are any reason for the company change the hour of results to be out. First is to be AH, now is until the market opens, i hope to heard good news!
If they have the approved don't see any doubt the AFFY will be above $14 in minimum!
AFFY..$10.41 March is around the corner and so is their PDUFA date of March 27th. Should start to move higher here soon into their PDUFA. Extremely low market cap for the space that the company is in.
DNDN..$15 it could see a sharp spike higher to $15.15 end of day if market does not melt here at the close.
Correct!i believe to see higher next week! Let's see, good luck to all.i'm in!
Excellent..when trading in your portfolio think "incremental" instead of "monumental" and it will go a long way in growing your portfolio.
Message in reply to:
Sheff, I was doing some goal setting earlier this month...to be successful I just need the 10% ers.... think what that would do to a profolio over a period of a few years ...10% trades more often...
I have changed my approach...looking for solid gains..not braggart wins and shut my mouth losses
Sheff, I was doing some goal setting earlier this month...to be successful I just need the 10% ers.... think what that would do to a profolio over a period of a few years ...10% trades more often...
I have changed my approach...looking for solid gains..not braggart wins and shut my mouth losses
PGNX..$10.08 Nice trade Cabos! That is what we are after here and that is singles. Every now and then we get a home run but we want high percentages here. We want to limit the strikeouts!
DNDN..$15 They have earnings next Monday. Could see solid upside on this one next week. High alert here for an entry.
TLON..$.89 Just moving along nicely here. 3 weeks from Advisory Panel on March 21st. Company is doing all the right things with the FDA. I will dive into this more in the coming weeks. Lots of ammunition here!
RGEN..$4.25 I expect big things here from this company in the next few months. A lot of cash and no debt as well. A low float company with historically low volume.
Message in reply to:
RGEN..$4.26 Will be looking to take a position here soon. Company has priority review for their Secreflo as well as solid data of it in use with an MRI.
Repligen announced that the FDA has accepted for filing and granted Priority Review to the co's new drug application for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis (RGEN) 4.21 : Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo NDA.
Out PGNX at 10.05 from 9.54 entry.
Thanks Sheff for a solid base hit!
ECYT..$3.52 is lying dormant here. Waiting for this one to pop here. March will be a busy month!
PGNX..$10.07 is over $10 now. Nice two day run here!
CHTP:FDA Advisory Panel Recommends Approval of Chelsea's NORTHER(TM) (droxidopa) for the Treatment of Symptomatic Neurogenic OH
CHARLOTTE, N.C., Feb. 23, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP - News) today announced that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA(TM) (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (also known as Neurogenic OH or NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Deutsche Bank Sees Upside in Chelsea Therapeutics (CHTP) to $9 On FDA Approval
http://www.streetinsider.com/Analyst+Comments/Deutsche+Bank+Sees+Upside+in+Chelsea+Therapeutics+%28CHTP%29+to+%249+On+FDA+Approval/7210845.html
http://finance.yahoo.com/news/FDA-Advisory-Panel-Recommends-pz-1041433021.html?x=0
Investor 100
CYTR: Form 4 (today)
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8090284
GL
Investor 100
YM BioSciences prices $70 million public offering of common shares
Feb 24 (Reuters) - YM Biosciences Inc <YM.TO>:
* Prices $70 million public offering of common shares
* Says offering of 35 million common shares priced at $2.00 per share
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))
((For more news, please click here [YM.TO]))
Celldex Announces Public Offering of Common Stock <CLDX.O>
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20120223:nBw236682a
NEEDHAM, Mass.--(Business Wire)--
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that it is offering
shares of its common stock in an underwritten public offering. All of the shares
in the offering will be sold by Celldex. The offering is subject to market
conditions, and there can be no assurance as to whether or when the offering may
be completed, or as to the actual size or terms of the offering. The shares will
be issued pursuant to a prospectus supplement filed as part of a shelf
registration statement previously filed with the Securities and Exchange
Commission (SEC) on Form S-3.
Jefferies & Company, Inc. is acting as the sole book-running manager for the
proposed offering. Wedbush PacGrow Life Sciences, Oppenheimer & Co. Inc., Brean
Murray, Carret & Co. and Roth Capital Partners, LLC are acting as co-managers
for the proposed offering.
A shelf registration statement relating to the shares was filed with the
Securities and Exchange Commission and is effective. A preliminary prospectus
supplement related to the offering will be filed with the SEC and will be
available on the SEC's website located at www.sec.gov. Copies of the preliminary
prospectus supplement and the accompanying prospectus relating to this offering
may be obtained from Jefferies & Company, Inc., Attention: Equity Syndicate
Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY, 10022, or
by telephone at 877-547-6340, or by email at
Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of
an offer to buy these securities, nor shall there be any sale of these
securities in any state or other jurisdiction in which such offer, solicitation
or sale would be unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction. Celldex intends to file
a preliminary prospectus supplement relating to the offering with the SEC, which
will be available along with the prospectus filed with the SEC in connection
with the shelf registration, on the SEC's website at www.sec.gov.
Future Link & Business News
http://www.finviz.com/futures.ashx
Jobless claims unchanged at four-year low
New claims for unemployment benefits were unchanged in the latest week, foiling expectations that they would rise and providing further evidence that the job market was slowly healing.
http://bottomline.msnbc.msn.com/_news/2012/02/23/10486216-jobless-claims-unchanged-at-four-year-low
JC Penney Earnings Top Estimates Even as Sales Fall
JC Penny posted quarterly earnings that beat Wall Street's estimates, sending its shares higher in premarket trading.
http://www.cnbc.com/id/46468949
Citi Sells Stake in India's HDFC Bank for $1.9 Billion
Citigroup sold its stake in India's Housing Development Finance for $1.9 billion, as global banks focus on shoring up their balance sheets to meet stricter capital requirements.
http://www.cnbc.com/id/46507585
Lloyds Makes $5.5 Billion Loss, Gives Gloomy Outlook
Lloyds Banking Group, the state-backed UK bank, said Friday that it made a 3.5 billion pound ($5.5 billion) pre-tax loss in 2011, down from a profit of 281 million pounds in 2010, and warned that its outlook remained “challenging.”
http://www.cnbc.com/id/46508834
Long-term investments in Facebook could be a bad bet, experts warn
Investors, social media watchers and Facebook users may be looking forward to the social network’s expected public stock offering later this year, but corporate governance experts aren’t quite so enthusiastic.
http://bottomline.msnbc.msn.com/_news/2012/02/24/10489066-long-term-investments-in-facebook-could-be-a-bad-bet-experts-warn
Investor 100
CHTP: Pre-market $4.17 (+72%)
Nice MOMO coming into this stock today!
GLTA
Investor 100
Onty? any one know whats going on with this one?
CHTP..$4.21 (AH) FDA panel recommends Chelsea Therapeutics drug. http://dlvr.it/1Dz7dv
ECYT..$3.54 Catalysts upcoming: Two investment conference in Feb. Citibank on 27th & RBC Capital on 28th.
NEAR-TERM CATALYSTS
3/1 Endocyte (ECYT) Earnings Q4:11 results and update on path forward in the EU and other programs
3/24-3/27 Endocyte (ECYT) Clinical Data
Potential presentation of updated PFS and overall survival Data from the
randomized PII study of EC145 in the platinum resistant ovarian cancer setting
Society for Gynecologic Oncology; Austin, TX
Thanks for the quick reply. Have a good evening!
Is it a positive for the stock? I have no idea about these votes. Thanks!
CHTP vote: 7 Yes to 4 No 1 Abstain 1 No vote
AMRN..$8.99 Missed my opportunity to buy back in today. Rats!! It took off strong this morning. Was not watching it very close and now...there she goes!
If SCON no close above a buck _> stop out for now
Nice move on this one today.
Follow Me on Twitter: http://twitter.com/SheffStation/
New Economy Portfolio: Larger Cap stocks for slower but more consistent gains. Some Longer-Term Plays (30-60 days maybe longer)
Beginner Portfolio: Scalp Plays & Low Float Biotechs for potential explosive Growth. Quick Turnover 1-30 days (smaller balance want aggressive growth)
Position Size: STARTER: (1-5% Portfolio Balance) SOLID: (6-10% Portfolio Balance) FULL : (11-20% Portfolio Balance)
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$HEFF LEARNING STATION-LINKS
REAL-TIME Futures Quotes: http://www.sgxniftydowfutureslive.com/index_files/DOWFUTURES.htm …
JANNEY HEALTHCARE NEWSLETTER-http://www.janney.com/institutions--corporations/investment-banking/industry-groups/healthcare/life-sciences-newsletter
Traders: Develop Your Mental Edge by Dr. Andrew Menaker http://j.mp/1phyFIY
Jesse Livermore-Reminiscences Of A Stock Operator-Great Book http://bit.ly/VOObyM
LIFE SCIENCES MARKET : http://www.thelifesciencesreport.com CHMP Decisions Here: http://t.co/7jjqFyn3tx
E-booklet onTrend Determination: A quick accurate and effective methodology using RSI. http://bit.ly/17PmHZ8
The Original Turtle Trading Rules: Rules of the “Turtle Traders;” one of the greatest trading experiments conducted.
http://bit.ly/17jXegf
FAVORITE QUOTES:
"Compounding interest is the eighth wonder of the world. He who understands it, earns it..he who doesn't.. pays it." - Albert Einstein
"Your actions speak so loud I can't hear your words! When that happens, you have found a certain level of success others haven't." Sheff
"IF YOU ARE NOT TAKING YOUR PROFITS, SOMEBODY ELSE IS !" SHEFF
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Favorite Sheff Quote: "You can't let praise or criticism get to you. It's a weakness to get caught up in either one." -John Wooden
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A Trading Plan = Study. A watch-list. Position Sizing. Entries. Exits. Records. Discipline. h/t @sjburns
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