has asked Dr. Walter Hauck to provide us with his assessment of the PTIT issues and how the IPAC-RS approach deals with them.
And then question number 2 is an issue that was raised by Dr. Hussain, and it has to do with a validation of manufacturing processes issue. It says, does ACPS feel that the DCU quality standards should provide an assurance that batch failure rates do not exceed some specified level, e.g., 10 percent?
The genesis of that question comes about from a court decision back in February of 1993, Judge Wolin, who said the following, and I'm paraphrasing. The government first argues that the failure rate associated with the firm's products demonstrate the need to revise the underlying manufacturing processes. To the extent that batches included in retrospective studies exhibit a failure rate of 10 percent or more, the court agrees. So, therefore, we've been looking at this 10 percent issue and trying to determine if somehow this level of protection could be built into this test.
Now, we could look at this in a couple of ways. One is to say that the DCU test is only one of a