I'm long and holding but more DD is needed on the Hollister/Stier 483 and the Lovelace lab tests. These two issues have been in every 10Q this year and date back to 2008.

In the 10Q on March 16th, 2009 we see the following:

http://www.sec.gov/Archives/edgar/data/9...

"The FDA conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington in mid-2008 (June 19 to July 2, 2008). The Ampligen(R) final
fill operations are performed under contract with Hollister-Stier. The
inspection resulted in a Form FDA 483 with two observations dealing with reviews
and validations of process variability. We are working with Hollister-Stier to
finalize specific actions."

"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(R) NDA. These studies were
requested by the FDA and will be done in collaboration with the resources of the
New Brunswick facility. We expect these studies to be complete in April 2009."

Dr. Carter did not lie in his statements and conf calls. I believe that Dr. Carter truely believed he would get an NDA decision on May 25th. He must have assumed that the Hollister Stier 483 and validated Lovelace toxicology results did not need to be fully completed before a final decision. (i.e. there is 20 years of safety data on humans already) JJ has shown examples NDA approvals without toxicology data in place. I recall he also gave an example of NDA approval given with only an action plan to resolve a 483.

Looks like it took 1 year to resolve the 483 at Hollister-Stier and to produce validated Lovelace reports. Does it normally take this long to complete these? These are separate companies and not much Dr Carter can do here.

Yesterday's PR also used the word "pharmacokinetic" to describe the Lovelace studies which will be completed in Nov/Dec.

Pharmacokinetic definition is:
The process by which a drug is absorbed, distributed, metabolized and eliminated by the body.
http://www.answers.com/topic/pharmacokin...

The great news is now we know that efficacy is NOT the reason for the FDA delay. If efficacy were the issue, we would have received a CRL in Feb or May. Adam F-Stein is an idiot to think there is still an issue about efficacy. The delay is about the FDA not getting what it requested from HEB.