...I would not expect anything till mid november at least...
IMO by Oct. 23rd.
Although, I keep thinking about the 10-Q (August 7, 2009) statements about the third party facility and the toxic test results (pg. 22).
Most important is this:
A satisfactory recommendation from the FDA Office of Compliance based upon an acceptable preapproval inspection is required prior to approval of the product.
Looks like two issues:
(1)
The FDA conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington in mid-2008. The Ampligen® final fill operations are performed under contract with Hollister-Stier. The inspection resulted in a FDA Form 483 with two observations dealing with reviews and validations of process variability. We continue to work with Hollister-Stier to finalize specific actions to address the FDA Form 483 issues and Hollister-Stier has submitted a specific action plan to the Seattle, Washington office of the FDA. It is our expectation that these issues will be resolved and we will be able to complete the resultant sequential validations by the end of 2009.
(2)
On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen® NDA. These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility. These studies have been substantially completed with summary reports expected to be issued to the FDA during the third quarter of 2009. Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010.
If there is a satisfactory recommendation and the studies are completed, we're on the home stretch.
GLTA
HEB Long
