Checking the 10-Q, August 7, 2009
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.
The FDA may have decided already. They could be withholding the final approval until they get all items checked off their list and this may one of two items, IMO, not completed.
IMO, the other is the pending recommendation from the Seattle FDA office.
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.
Hopefully these two items are completed sooner than later.
It's been a long dance.
GLTA
HEB Long
