Larry Smith

Question 1

Larry Smith's questions to WINDTREE THERAPEUTICS INC /DE/ (WINT) leadership • Q4 2015

Mar 10, 2016

Question

Larry Smith asked for a potential timeline for the completion of a Phase III trial, assuming positive Phase IIb results, and questioned the potential regulatory issues arising from the variable dosing strategy in the Phase IIb trial.

Answer

CEO Craig Fraser and Chief Development Officer Dr. Steve Simonson responded that it is premature to forecast a Phase III timeline, as the trial's size and design will depend on the effect size demonstrated in the Phase IIb study. Regarding dosing, Dr. Simonson confirmed that while repeat dosing is based on clinical need, the data gathered will be crucial. Craig Fraser added that the Phase IIb results are expected to help them "zero in" on a more optimal dosing regimen for the pivotal Phase III program, which will ultimately inform the product's label.

Ask Fintool Equity Research AI

Question 2

Larry Smith's questions to WINDTREE THERAPEUTICS INC /DE/ (WINT) leadership • Q2 2015

Aug 11, 2015

Question

Larry Smith sought confirmation on the patient numbers and dosage in the completed 60-minute dose group, asked about repeat dosing instances, enrollment timelines, the safety committee's criteria for advancing to a 90-minute dose, the occurrence of pneumothoraces, and the expected timing for topline data release. He also questioned the plan to include younger babies in the Phase IIb trial before full safety data is available and inquired about the nature of the NIH grant.

Answer

CEO John Cooper confirmed the 16-patient cohort (8 AEROSURF, 8 control) for the 60-minute dose group was enrolled in under two months but stated that specific data on repeat dosing or adverse events like pneumothoraces would not be released until the full trial segment is complete. Chief Development Officer Steven Simonson explained the safety committee reviewed standard safety and tolerability data before approving the 90-minute dose. Cooper affirmed the company is on track to complete the study in Q4 and expects to release topline data for the 29-34 week group by year-end. Simonson clarified the Phase IIb trial has a staggered start, pending safety results from the younger cohort's Phase IIa study. Both executives confirmed the NIH grant is for an animal model study.