301 results
8-K
EX-99.1
WINT
Windtree Therapeutics Inc
25 Nov 03
Other events
12:00am
independent Data Safety Monitoring Board (DSMB) informed the study's Steering
Committee and Discovery that the trial had achieved statistical significance … and a bioethicist,
were responsible for monitoring the overall safety of the trial. The DSMB
informed Discovery that statistical significance was achieved
8-K
EX-99.1
WINT
Windtree Therapeutics Inc
18 Apr 16
Amendments to Articles of Incorporation or Bylaws
12:00am
unmet needBuilding a data base of potential safety, clinical effect and benefit informationOpportunity to build a positive health economic … program is primarily to assess safety and understand the proper dosing regimen to support premature infants to surfactant self-sufficiency 13
Phase
8-K
EX-99.2
WINT
Windtree Therapeutics Inc
9 Dec 04
Entry into a Material Definitive Agreement
12:00am
call today at 11:00 AM EST. The call in number is 800-665-0669.
The ARDS Phase 2 trial is comprised of two parts; a dose-escalation/safety phase … and an efficacy/safety phase. As of November 15, 2004, a total of 89 patients were enrolled in the trial and completed the 28-day study. The table below
8-K
WINT
Windtree Therapeutics Inc
29 Jul 11
Other Events
12:00am
necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are: (i) Class I General … be made without using the 510(k) process if the changes do not significantly affect safety or effectiveness.
Pre-market Marketing Authorization
8-K
EX-99.1
WINT
Windtree Therapeutics Inc
7 Mar 12
Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome
12:00am
. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program … that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.
IMPORTANT SAFETY INFORMATION
8-K
EX-99.1
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31 Mar 06
Discovery Labs Announces Preliminary Results of Phase 2 Clinical Trial in ARDS
12:00am
8-K
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25 Nov 03
Other events
12:00am
8-K
EX-99.1
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31 May 19
Istaroxime Phase 2b Study Results Presented in Late Breaker Clinical Trial Session at the ESC Heart Failure Congress
4:17pm
8-K
EX-99.1
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5 May 22
Windtree Therapeutics Reports First Quarter 2022 Financial Results and Provides Key Business Updates
4:04pm
8-K
EX-99.1
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9 Jun 10
Discovery Labs Reports Preliminary Results from Phase 2 Clinical Trial of Surfaxin in Pediatric Acute Respiratory Failure
12:00am
8-K
v46ylnlda29p
31 Mar 06
Discovery Labs Announces Preliminary Results of Phase 2 Clinical Trial in ARDS
12:00am
8-K
EX-99.1
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14 Aug 19
Windtree Therapeutics Reports Second Quarter 2019 Financial Results and Provides Key Business Updates
12:00am
8-K
EX-99.1
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28 Sep 11
Other Events
12:00am
8-K
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5 Aug 14
Discovery Labs Reports Second Quarter 2014 Financial Results
12:00am