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Saturday, 05/16/2015 10:46:23 AM

Saturday, May 16, 2015 10:46:23 AM

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The Company outlined its plans for additional phase 2 clinical assessment, including a phase 2a dose expansion in 29 to 34 weeks gestational age infants to evaluate increased doses and repeat dosing, which is expected to begin in the second quarter of 2015 and be completed in the fourth quarter of 2015; a phase 2a clinical trial assessing the safety and tolerability of escalating doses of AEROSURF administered to 26 to 28 weeks gestational age infants, with an ability to administer repeat doses, which is expected to begin in July 2015 and be completed in the fourth quarter of 2015; and a phase 2b clinical trial to determine the optimal dose and define the expected efficacy margin of AEROSURF treatment, which is expected to begin in the fourth quarter of 2015 and be completed in mid 2016.

In addition, the Company reaffirms its forecast set forth in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, as follows: before any additional financings the Company anticipates that it will have sufficient cash available to support the AEROSURF clinical program as outlined in this Current Report on Form 8-K, pay debt service and fund its operations through the first quarter of 2016.
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