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Windtree Therapeutics Inc. (WINT)

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Last Post: 10/9/2018 3:39:07 PM - Followers: 106 - 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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News News Alert: Current Report Filing (8-k) 10/16/2018 04:41:57 PM
PlusOneCoin Top Posts
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PostSubject
#3059   Would somebody please be kind enough to inform big bambino 10/09/18 03:39:07 PM
#3058   Shanak10: I too was just about to post big bambino 07/24/18 11:40:14 AM
#3057   https://finance.yahoo.com/news/windtree-announces-completion-design-development- shanak10 07/23/18 04:36:29 PM
#3056   https://finance.yahoo.com/news/westpay-additional-order-absa-bank-110810833.html shanak10 06/19/18 07:44:38 AM
#3055   https://backend.otcmarkets.com/otcapi/company/sec-filings/12755955/content/html shanak10 05/15/18 12:20:21 PM
#3054   Shanak10: Thanks for the heads up on the 13D big bambino 04/16/18 09:54:40 AM
#3053   https://backend.otcmarkets.com/otcapi/company/sec-filings/12684947/content/html shanak10 04/16/18 07:07:36 AM
#3052   Seems, Lee Pham acquired 541,000 shares on Wednesday. big bambino 04/07/18 01:45:44 AM
#3051   I don't follow changes in board, but hope RodinLP 04/04/18 05:12:11 PM
#3050   Rodinlp: Thanks for the reply. Unfortunately big bambino 04/04/18 02:53:52 PM
#3049   Unfortunately I don't know either what we're waiting RodinLP 04/04/18 02:07:47 PM
#3048   I can't seem to get an answer or big bambino 04/03/18 02:55:14 PM
#3047   8K http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=12505287 shanak10 01/30/18 06:36:28 PM
#3046   8K http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=12505287 shanak10 01/30/18 06:35:57 PM
#3045   starting to get to where it belongs. big bambino 01/05/18 01:01:59 AM
#3044   Moving along nicely. shanak10 01/04/18 11:08:57 AM
#3043   Nice move today. shanak10 01/02/18 02:14:11 PM
#3042   $WINTD Windtree Therapeutics Announces Reverse Stock Split Source: PR $Pistol Pete$ 12/23/17 04:59:38 PM
#3041   David: It had to happen. Maybe big bambino 12/21/17 12:18:41 PM
#3040   1:20 R/S Tomorrow, per FINRA: http://otce.finra.org/DailyList davidsson10 12/21/17 05:18:07 AM
#3039   Shanak10: nice find and share. big bambino 12/10/17 01:20:31 AM
#3038   looks to me like LEE’S PHARMACEUTICAL HOLDINGS LIMITED shanak10 12/09/17 09:11:19 PM
#3037   I tried calling P/R 3 separate times and big bambino 12/08/17 12:56:48 AM
#3036   I suppose if I were more motivated I wodehouse 12/07/17 04:11:58 PM
#3035   I do remember. Both here and Yahoo, big bambino 12/07/17 04:06:47 PM
#3034   Remember when this was Discovery Labs? Lots of wodehouse 12/07/17 03:06:14 PM
#3033   So does Scottrade. Don't know who keeps big bambino 12/07/17 02:50:20 PM
#3032   Yahoo has days range .25-.30. wodehouse 12/07/17 02:29:23 PM
#3031   WHERE THE H__L IS IHUB GETTING THERE BID big bambino 12/07/17 01:47:00 PM
#3030   Pop goes the weasel. willlbone 11/29/17 11:25:32 AM
#3029   Hello, is anyone home? shanak10 11/22/17 01:31:27 PM
#3028   Nice 13D filed today. shanak10 11/21/17 03:44:03 PM
#3027   Something must be up. To rise 100% big bambino 11/07/17 10:08:05 AM
#3026   Looks like this restructuring with Lee Pharm & big bambino 11/03/17 07:21:40 PM
#3025   Are there any events we can hope for big bambino 09/12/17 06:52:27 PM
#3024   Probably because it was a Friday before a RISK-TAKER 07/02/17 08:10:49 PM
#3023   Then why is it is there no volume today? wodehouse 06/30/17 03:18:06 PM
#3022   Due for a big bounce imo because weak BERKSHIRE AGENT 06/30/17 02:32:52 PM
#3021   It was good news though right? Brooksda 06/30/17 02:28:56 PM
#3020   Hi BA, why is that? adamski 06/30/17 01:35:34 PM
#3019   Buying here. MEGA bounce Commeth BERKSHIRE AGENT 06/30/17 01:26:36 PM
#3018   Thanks for your input. Best of luck big bambino 06/30/17 01:15:41 PM
#3017   Hello Big Bambino, H2R 06/30/17 12:00:18 PM
#3016   I'm in...looks interesting that filters were the issue.. RISK-TAKER 06/30/17 10:41:23 AM
#3015   H2R: are there any other catalyst after this big bambino 06/30/17 10:18:51 AM
#3014   Hi Davidsson10, H2R 06/29/17 05:42:04 PM
#3013   http://www.marketwatch.com/story/windtree-announces-top-line-results-from-aerosu davidsson10 06/29/17 04:08:26 PM
#3012   SoS article after the Lee's agreement: H2R 06/15/17 02:47:26 PM
#3011   Thanks H2R, Great news, when we haven't had big bambino 06/12/17 07:11:51 PM
#3010   Hi wodehouse, H2R 06/12/17 07:10:49 PM
PostSubject