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Windtree Therapeutics Inc. (WINT)

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Last Post: 9/29/2020 10:19:40 AM - Followers: 101 - 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.


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


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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#3092   More breaking news: Windtree Announces FDA Acceptance of big bambino 09/29/20 10:19:40 AM
#3091   Breaking News: $WINT Windtree to Present at H.C. whytestocks 09/08/20 04:00:32 PM
#3090   I was actually in this year’s ago when wodehouse 08/21/20 09:39:42 AM
#3089   I think they finally got back to work big bambino 08/21/20 09:29:21 AM
#3088   Any idea what happened the end of July Barrydeep 08/20/20 11:16:00 PM
#3087   9 years with this stock and @ $188 big bambino 08/20/20 02:42:13 PM
#3086   thanks PennyWorld 06/07/20 10:07:01 AM
#3085   The FINRA link is only good for the Renee 06/06/20 06:48:43 PM
#3084   This link is not pulling up anything for PennyWorld 06/06/20 03:48:06 PM
#3083   WINT moved to the Nasdaq from the OTC: Renee 05/20/20 08:58:41 AM
#3082   Have not seen any trades in last 2 days? big bambino 04/30/20 10:01:54 AM
#3081   WINT one for 3 reverse split: (***PPS closed Renee 04/28/20 04:34:15 PM
#3080   Does anyone know when the next catalyst for big bambino 03/03/20 09:28:54 AM
#3079   Nice to see CEO purchasing shares big bambino 02/13/20 10:58:04 AM
#3078   Finally some movement! big bambino 01/27/20 05:53:50 PM
#3077   I think I will just sell mine for shanak10 08/14/19 10:24:00 AM
#3076   Not really, they reinvented themselves and apparently didn’t wodehouse 08/14/19 10:21:07 AM
#3075   Not really but would look it up if shanak10 08/14/19 10:14:40 AM
#3074   Remember when this was Discovery Labs? wodehouse 08/14/19 10:11:13 AM
#3073   The street does not seem to like the news. shanak10 08/14/19 10:09:51 AM
#3072   The street is jumping up and down with wodehouse 08/14/19 09:36:13 AM
#3071   My pleasure. GL shanak10 08/13/19 04:41:12 PM
#3070   Thanks for the heads up. wodehouse 08/13/19 04:34:41 PM
#3069   https://www.otcmarkets.com/stock/WINT/news/story?e&id=1416373 shanak10 08/13/19 04:22:35 PM
#3068   I sold out years ago, but lurking to wodehouse 06/11/19 10:39:52 AM
#3067   wodehouse: I too have been in long before big bambino 06/11/19 10:21:45 AM
#3066   Yeah, but only 1688 shs traded, I was wodehouse 06/10/19 03:12:21 PM
#3065   I haven't seen this stock close to $5 big bambino 06/10/19 11:32:59 AM
#3064   I guess no one was impressed with CC, big bambino 01/03/19 04:07:00 PM
#3063   8K https://www.otcmarkets.com/filing/html?id=13131446&guid=zjL8Ual6YPlHb3h shanak10 12/31/18 05:17:01 PM
#3062   And some 13D forms today. shanak10 12/31/18 04:10:51 PM
#3061   A lot of SEC form 4's last week, big bambino 12/29/18 11:21:46 PM
#3060   Merry Christmas to all! big bambino 12/22/18 06:53:07 PM
#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
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