Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Below is a summary of press releases from Acusphere, Inc. (OTC:ACUS) from this year, which are available in full directly from the Company's website at http://www.acusphere.com/. Based on the most recent press release last week, ACUS expects to have sufficient liquidity to fund operations until the end of 3Q09 due to cost-cutting initiatives.
However, the most recent press release states that discussions with the FDA continue regarding the design of a clinical program to address the FDA's complete response letter (CRL) for Imagify and makes no mention of the amended NDA with a narrower claim referenced in earlier press releases. While previous press releases in February and March mentioned FDA meetings to "discuss alternatives", an "amended NDA", and a "narrower claim" for Imagify; the Company's latest press release from 5/19/09 only mentions that discussions continue with the FDA regarding the design of a clinical program to satisfy the issues raised in the CRL by the FDA for Imagify.
Since ACUS no longer mentions the amended NDA for Imagify as part of its discussions with the FDA; there is no definitive timeline for a FDA decision on the NDA until further notice from the Company on the strategy and timeline to satisfy the issues raised by the FDA in the CRL for Imagify. BioMedReports.com contacted the Company in an attempt to receive more clarity on the strategy and timeline for Imagify in early May, but has not received a response as of yet.
The other major variable with ACUS beyond the Imagify story at the FDA the role of Cephalon (NASDAQ:CEPH) as the Founder, Chairman, and CEO of CEPH, Dr. Frank Baldino, also serves on the Board of Directors for ACUS.
