The Management of Advanced Life Sciences Holdings, Inc. (ADLS) held a conference call today to address concerns regarding a FDA workshop last week and an upcoming meeting of the Anti-Infective Drugs Advisory Committee to discuss product development and clinical trial design for community acquired pneumonia (CAP).
Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences, said, As part of a mandated review process, the FDA is reviewing CAP trials through workshops. The Company anticipates that upcoming meetings will continue the discussions conducted last week, but an agenda is unknown at this time."
"We view the workshop as an idea generation event. Participants are focused on appropriate margins for the trials and scientific justification for those margins, because of the serious nature of the disease. The spotlight on antiobiotic resistance continues to grow. If approved our Cethromycin is well positioned to address these issues."
"The workshop discussions were not worrisome. We have confirmed suitability of our trial design. We have captured extensive important data to support development. We believe that our plans are on track for a strong NDA submission, and no meetings or conversations with the FDA have changed that. We feel certain that changes will not be placed on our trials."
"Be assured that nothing clinical is on hold."
Dr Flavin added, "We have also made progress with prospective partnerships and feel that developments regarding these could be likely in 2008."
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