keep an eye on ACUS if it keeps trending lower.......def speculative though:
Acusphere (ACUS): In February, ACUS.PK amended its New Drug Application (NDA) for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. The amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use.
On 3/11/09, Acusphere received a complete response letter (CRL) from the FDA which stated that additional clinical studies would be necessary for the Company's original broad label of use claim.
The goal of the amended NDA and narrower claim for Imagify is to improve the risk/benefit ratio for the cardiac imaging agent by limiting its use to patients undergoing pharmacologic stress tests so that additional clinical studies are not required as outlined in the CRL from the FDA. The last update from Acusphere indicated that the Company was invited by the FDA to discuss alternatives and is in the process of scheduling such a meeting. In addition, Acusphere has implemented cost-cutting measures, including a workforce reduction of 40 people (about two-thirds of all employees), moving the stock listing to the pink sheets, suspending SEC reporting obligations, and terminating the Company's Watertown, MA headquarters lease and relocating all personnel to its facility in Tewksbury, MA.
The previous estimated decision date for Acusphere in the BioMedReports.com FDA calendar for Imagify was 5/31/09. However, since the FDA issued a CRL on 3/11/09 for the original NDA with a broad claim of use label, the exact timeline for a new decision on the amended NDA with a narrower claim is still pending. The aggressive cost-cutting initiatives by the Company provide expected liquidity to fund operations into 3Q09, which provides time for Acusphere to explore strategic partnerships and financing arrangements as discussions continue with the FDA to clarify the timeline for a new decision on the amended NDA.
