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Windtree Therapeutics Inc. (WINT)

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Last Post: 5/9/2017 11:24:34 AM - Followers: 112 - 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 

May 13, 2011       A Brighter Decade Ahead for Biotech - Equity Research on Discovery Laboratories and Mylan Inc   

May 11, 2011 8k     

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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Current Price
Bid Ask Day's Range
WINT News: Proxy Statement (definitive) (def 14a) 05/18/2017 05:30:52 PM
WINT News: Quarterly Report (10-q) 05/15/2017 05:43:47 PM
WINT News: Proxy Soliciting Materials (revised) (prer14a) 05/09/2017 01:01:30 PM
WINT News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 05/08/2017 05:30:39 PM
WINT News: Current Report Filing (8-k) 05/03/2017 04:17:28 PM
#3001   OVER SOLD ! DeafTrader2 05/09/17 11:24:33 AM
#3000   WINT delisted from the Nasdaq to the OTC: Renee 05/04/17 05:07:07 PM
#2999   I picked up another 4k@.79. Was going big bambino 05/04/17 03:56:51 PM
#2998   Getting delisted from the NASDAQ is what is jonnyb 05/04/17 11:24:28 AM
#2997   What is going on with the stock? docprep 05/01/17 09:53:59 PM
#2996   Thanks Padin, H2R 04/12/17 09:05:36 AM
#2995   The product sounds awesome i would love to Padin 04/11/17 11:04:26 PM
#2994   Hi Padin, H2R 04/11/17 10:53:07 PM
#2993   * * $WINT Video Chart 04-11-17 * * ClayTrader 04/11/17 05:17:21 PM
#2992   I work on a level 3 NICU i Padin 04/11/17 04:12:22 PM
#2991   I believe it's between the synthetic makeup and big bambino 04/11/17 04:09:40 PM
#2990   My question would be how does the drug Padin 04/11/17 03:51:53 PM
#2989   Nice job Big Bambino :) H2R 04/11/17 03:15:38 PM
#2988   H2R, big bambino 04/11/17 02:59:42 PM
#2987   H2R, big bambino 04/11/17 02:59:30 PM
#2986   Ph 2b Catalysts: Reuters H2R 04/11/17 10:10:35 AM
#2985   WINT Cash Position H2R 03/31/17 10:13:31 AM
#2984   WINT Catalysts H2R 03/31/17 10:11:05 AM
#2983   Sorry, wrong post. big bambino 03/21/17 11:13:42 PM
#2982   First time I've ever seen shares sold A/H. big bambino 03/21/17 04:53:00 PM
#2981   Windtree Therapeutics, Inc. (NASDAQ:WINT) Files An 8-K Other trendmkr 02/16/17 03:03:00 PM
#2980   Latest Institutional Activity, Top 10 Owners of Windtree lecorb 02/16/17 12:45:34 PM
#2979   WINT: Consensus reco Buy:1 Outperform:1 lecorb 02/16/17 11:47:02 AM
#2978   From the 13G SEC filing today, it looks value1008 02/10/17 05:33:56 PM
#2977   WINT new Presentation , Phase2, September2016,Fast Track designation ash111 02/03/17 12:10:20 PM
#2976   holding mine. there is a reason for those ash111 02/03/17 10:39:53 AM
#2975   No but would love to see another 1M ElCollector 02/03/17 08:22:30 AM
#2974   Nice 27% up day :) H2R 02/02/17 06:07:49 PM
#2973   If the drug is good this will trading ash111 02/02/17 05:24:14 PM
#2972   Do you know who is buying bigly here ? ash111 02/02/17 05:12:54 PM
#2971   Recently Brokerages Set $5.65 Target Price for Windtree ash111 02/02/17 04:11:52 PM
#2970   Baker Bros, Sabby, big names. ash111 02/02/17 04:06:10 PM
#2969   I've been thru a few R/S's, but have big bambino 02/02/17 04:01:21 PM
#2968   nice P.T too ash111 02/02/17 03:54:58 PM
#2967   Very interesting indeed Ash. Need to do some rnoutlaw21 02/02/17 03:53:26 PM
#2966   WINT I think another stake coming. ash111 02/02/17 03:52:43 PM
#2965   Good luck. That 1/14 R/S must have been sour. Citrati 02/02/17 03:49:46 PM
#2964   I've been waiting since April of '13 for big bambino 02/02/17 03:44:12 PM
#2963   Yes, exactly. Citrati 02/02/17 03:40:05 PM
#2962   yes and that's very rare also not to ash111 02/02/17 03:37:43 PM
#2961   There is definitely accumulation going on as the Citrati 02/02/17 03:36:38 PM
#2960   WINT-wow about 1m shares been bought since Aug. ash111 02/02/17 03:32:49 PM
#2959   WINT ty. nice information. where the huge buy ash111 02/02/17 03:19:00 PM
#2958   'ash111' about your post on WINT on your Citrati 02/02/17 03:13:11 PM
#2957   This will go to $3-4 in the next week... ElCollector 02/02/17 12:19:09 PM
#2956   Looks like the market is taking this company big bambino 10/21/16 12:59:46 PM
#2955   Windtree Therapeutics to Host Conference Call and Webcast N_B 10/21/16 11:17:37 AM
#2954   Yessiree wodehouse 09/20/16 11:23:53 AM
#2953   FAST TRACK! => Gap Up? H2R 09/19/16 09:57:33 PM
#2952   So, no one knows nothing, and seems we've wodehouse 08/20/16 02:17:31 PM