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Discovery Laboratories Inc (DSCO)

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Last Post: 6/27/2015 8:13:43 AM - Followers: 99 - Board type: Free - Posts Today: 0

The Big Day is Coming!!!!!!!!!!


 The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.

 





Discovery Laboratories, Inc., a biotechnology company, engages in developing surfactant therapies to treat respiratory disorders and diseases based on its KL4 surfactant and capillary aerosol-generating technologies. Its development stage products include Surfaxin, a synthetic, peptide-containing surfactant in phase III clinical trial for the prevention of respiratory distress syndrome in premature infants; Surfaxin LS, a Phase III trial product to improve ease of use for healthcare practitioners; and Aerosurf, an aerosolized KL4 surfactant that has completed first pilot Phase II clinical trial for the treatment of respiratory distress syndrome in premature infants.

The company has a license agreement with Philip Morris USA Inc. to use its capillary aerosolization technology for use with pulmonary surfactants for the respiratory diseases and conditions; and a strategic alliance agreement with Laboratorios del Dr. Esteve, S.A. for the development, marketing, and sale of a portfolio of potential KL4 surfactant products in Andorra, Greece, Italy, Portugal, and Spain.

Discovery Laboratories, Inc. was founded in 1992 and is headquartered in Warrington, Pennsylvania.



 

MUST READ!!!!!!!!!!!!!!!!!

  On May 11, 2011, the Company issued a press release highlighting the results of operations for the quarter ended March 31, 2011, and providing an update on its pipeline development as follows:
 
Surfaxin® (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants: The Company is conducting a comprehensive preclinical program to validate its optimized biological activity test (BAT), a key remaining issue that must be addressed to potentially gain U.S. Food and Drug Administration (FDA) marketing approval for Surfaxin in the United States.  The Company has had several interactions with the FDA intended to ensure that the comprehensive preclinical program would ultimately satisfy the FDA.  In January 2011, the Company announced that the FDA had provided guidance to increase the sample size of a specific data set by testing additional Surfaxin batches.  To comply with the FDA's suggestion, the Company has successfully manufactured eight Surfaxin batches and presently plans to manufacture two additional Surfaxin batches for use in the comprehensive preclinical program. The Company presently plans to complete all related analytical testing and concordance studies, and be in a position to file a Surfaxin Complete Response in the third quarter of 2011.
 
Surfaxin LSTM (lyophilized lucinactant) for neonatal RDS :  The Company continues to advance this program. Its plans for 2011 include establishing a commercial-scale manufacturing capability at a cGMP-compliant contract manufacturer with expertise in lyophilized formulations and seeking regulatory guidance from the FDA and the European Medicines Agency (EMA) for the planned clinical development program.
 
Aerosolization Technology :  Recently, at the 2011 Pediatric Academic Societies Annual Meeting (PAS), new data was presented including: (i) a collaborative study indicating that aerosolized KL4 surfactant significantly improved lung function and survival when treating Acute Lung Injury in a well established preclinical model of this severe respiratory condition, (ii) a dose-ranging assessment of aerosolized KL4 surfactant in a widely recognized preclinical model of RDS, demonstrating significant improvement in lung function, lung structural integrity and pulmonary inflammatory mediator profile following treatment with aerosolized KL4 surfactant versus controls, and (iii) a study highlighting the Company's novel patient interface technology intended to increase the efficiency of pulmonary aerosol drug delivery to patients requiring positive pressure ventilatory support.
 
 
2

 

 
 
Regarding the Company's lead aerosolized KL4 surfactant program, Aerosurf® (aerosolized lucinactant for neonatal RDS), data from the preclinical dose ranging assessment study presented at PAS mentioned above suggests that, out of several doses tested, KL4 surfactant delivered via the Company's proprietary capillary aerosol generator during a 20 to 30 minute dosing interval results in the most favorable physiologic outcomes.  This study provides guidance for future clinical dosing strategies for this program. The Company's plans for 2011 include finalizing the clinical and potential commercial design of the capillary aerosol generator, finalizing the clinical and potential commercial design for the novel patient interface, and seeking regulatory guidance in the U.S. and Europe for the planned development program.
 
For the quarter ending June 30, 2011, the Company projects cash outflow of $5.8 million.

 





 

Investor Relations Contacts

John G. Cooper
Executive Vice President, Chief Financial Officer
Discovery Laboratories, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Tel. 215.488.9490
Fax. 215.488.9391
jcooper@discoverylabs.com


 



As of November 8, 2011, 24,499,497 shares of the registrant's common stock, par value $0.001 per share, were outstanding

As of  May 2, 2011, 24,178,502 shares of the registrant's common stock, par value $0.001 per share, were outstanding.  AutAeeeeee

Authorized 50 Mill

85 BM's 5-15-11



 

 

 

2010-11 Press Releases

 

May 13, 2011 10-Q http://ih.advfn.com/p.php?pid=nmona&article=47677338 

May 13, 2011 http://ih.advfn.com/p.php?pid=nmona&article=47666790       A Brighter Decade Ahead for Biotech - Equity Research on Discovery Laboratories and Mylan Inc   

May 11, 2011 8k http://ih.advfn.com/p.php?pid=nmona&article=47626029     

May 19, 2010
Discovery Labs Achieves Key Milestone Towards Potential Surfaxin® Approval

May 17, 2010
Discovery Labs' KL4 Surfactant Demonstrates Potential Protective Role for Lung Transplantation in Established Preclinical Model

May 14, 2010
Discovery Labs' Phase 2a Aerosurf® Study Published in Journal of Aerosol Medicine and Pulmonary Drug Delivery

May 5, 2010
Surfaxin LSTM Improves Pulmonary Function and Reduces Lung Inflammation in Established Model of Respiratory Distress Syndrome

April 28, 2010
Discovery Labs' KL4 Surfactant Data to be Presented at Pediatric Academic Societies Annual Meeting and American Thoracic Society International Conference

April 27, 2010
Discovery Labs Provides Updates on Surfaxin®, Other Key Programs and First Quarter 2010 Financial Results

March 10, 2010
Discovery Labs Reports Fourth Quarter 2009 Financial Results and Provides Business Update

February 23, 2010
Discovery Labs Announces Completion of $16.5 Million Public Offering

February 18, 2010
Discovery Labs Prices $16.5 Million Public Offering of Common Stock and Warrants

February 17, 2010
Discovery Labs Announces Proposed Public Offering of Common Stock and Warrants

February 16, 2010
Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval

January 19, 2010
POPG, a Key Component of Discovery Labs KL4 Surfactant, Identified as a Novel Anti-Viral Therapeutic Approach

 



Management Team View Bio

W. Thomas Amick, Interim CEO

Russell Clayton, D.O.
Vice President, Academic and Medical Affairs, Acting Head, Regulatory Affairs and Preclinical Research

Kathryn Cole
Senior Vice President, Human Resources

John G. Cooper
Executive Vice President, Chief Financial Officer

David L. Lopez, C.P.A., Esq.
Executive Vice President, General Counsel

Charles F. Katzer
Senior Vice President, Manufacturing Operations

Thomas F. Miller, Ph.D., MBA
Senior Vice President, Commercialization & Corporate Development

Gerald J. Orehostky
Senior Vice President, Quality Operations

Robert Segal, M.D., F.A.C.P.
Senior Vice President, Medical & Scientific Affairs, Chief Medical Officer

Mary B. Templeton, Esq.
Senior Vice President, Deputy General Counsel

 



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Last update: June 03,2010

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DSCO
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Option Chain for DSCO
DSCO News: Current Report Filing (8-k) 07/01/2015 07:48:29 AM
DSCO News: Discovery Labs Receives Nasdaq Notification Related to Minimum Bid Price 07/01/2015 07:30:00 AM
DSCO News: Current Report Filing (8-k) 06/09/2015 04:55:49 PM
DSCO News: Specialized Disclosure Report (sd) 05/21/2015 04:40:32 PM
DSCO News: Discovery Labs Announces Enrollment of First Patient in AEROSURF® Phase 2a Dose Expansion Trial 05/20/2015 07:30:00 AM
PostSubject
#2788   don't know. ..IDGC Fibanotch 06/27/15 08:13:43 AM
#2787   Where's the bottom? This looks like a king oil 06/26/15 09:47:13 PM
#2786   ill give it 6 mo's Fibanotch 06/25/15 04:03:51 PM
#2785   Looks like it's still headed down. The king oil 06/25/15 02:47:47 PM
#2784   should go north from here Fibanotch 06/21/15 08:58:41 AM
#2783   Thanks kofikbaz 05/20/15 06:49:52 PM
#2782   yup. probably headed for subpenny. king oil 05/20/15 02:38:47 PM
#2781   Still going to down? kofikbaz 05/19/15 11:47:13 PM
#2780   really? the long term trend is from king oil 05/18/15 07:50:11 PM
#2779   The Company outlined its plans for additional phase Transparency 05/16/15 10:46:23 AM
#2778   Filing that came out today said they have cheche770 05/15/15 01:16:58 PM
#2777   No this thing did not drop because of dmwes4 05/14/15 10:13:40 PM
#2774   It's amazing this thing got as far as king oil 05/14/15 06:46:29 PM
#2773   "This was shorted attacked hard" sunspotter 05/14/15 05:22:39 PM
#2772   I totally agree. bleu22 05/14/15 05:14:48 PM
#2771   This was shorted attacked hard cheche770 05/14/15 04:34:31 PM
#2770   how does it go lower than where it sunspotter 05/14/15 12:27:26 PM
#2769   how does it go lower than where it DITRstocks 05/14/15 12:22:22 PM
#2768   Nice target price. stressfreeliving 05/14/15 11:22:29 AM
#2767   I bought at 1.21 thinking perfect news, skyrocket cheche770 05/14/15 10:40:42 AM
#2766   Reuters Research: Target $3-$5. jfizx 05/14/15 10:40:03 AM
#2765   Less than 2 hours. Pretty crazy drop. KingDMC 05/14/15 10:17:39 AM
#2764   1.03 - 1.50 - .98 in less than DITRstocks 05/14/15 10:11:04 AM
#2763   Not sure I agree. sunspotter 05/14/15 09:51:38 AM
#2762   Eta see if she bounces off $1 KingDMC 05/14/15 09:51:26 AM
#2761   What a joke! DITRstocks 05/14/15 09:50:50 AM
#2760   Strong buy right here KingDMC 05/14/15 09:48:00 AM
#2759   And* KingDMC 05/14/15 09:47:31 AM
#2758   Ms there it is right on the money.... KingDMC 05/14/15 09:47:23 AM
#2757   Nice manipulation this morning. These mms are manipulating DITRstocks 05/14/15 09:41:27 AM
#2756   Where is that Gap sitting xlofer 05/14/15 09:03:28 AM
#2755   Got my eye on a trade here on KingDMC 05/14/15 08:50:47 AM
#2754   Discovery Labs Announces Results of Phase 2a Clinical KingDMC 05/14/15 08:46:40 AM
#2753   Have you been following? What's percentage on bleu22 05/13/15 02:40:16 PM
#2752   will announce top-line results from its AEROSURF® Phase DITRstocks 05/13/15 12:28:51 PM
#2751   Nice news here! Grold1387 05/13/15 12:13:43 PM
#2750   1.02 great entry DITRstocks 05/13/15 12:05:31 PM
#2749   http://ih.advfn.com/p.php?pid=news&symbol=N^DSCO [SMART MONEY] 05/13/15 12:03:38 PM
#2748   1.40 gap fill? DITRstocks 05/13/15 11:55:46 AM
#2747   52 week low .97 DITRstocks 05/13/15 11:50:15 AM
#2746   great news and the chart looks NICE DITRstocks 05/13/15 11:49:47 AM
#2745   top line results announced tomorrow as per news DITRstocks 05/13/15 11:49:31 AM
#2744   weeeeeeeee DITRstocks 05/13/15 11:43:41 AM
#2743   Nice drop today. willlbone 05/01/15 02:51:02 PM
#2742   Looks to me they were pushed and didn't jump. north40000 04/17/15 03:22:56 PM
#2741   Dumb people, I work closely with pulmonologists. There's dmwes4 04/17/15 02:59:04 PM
#2740   The rats are jumping ship. king oil 04/17/15 02:11:34 PM
#2739   UNITED STATES sunspotter 04/17/15 11:03:42 AM
#2738   I realize it may be "dead money" but someconcerns 04/14/15 10:28:44 AM
#2737   It's a real shame. I dumped it. This king oil 04/13/15 09:10:21 PM
PostSubject