Ann: GUIDANCE ON CLINICAL TRIAL UPDATES, page-20

I think they can recruit but they cannot dose. They may not be allowed to screen.

This is what happened with the Calimmune trial. Several patients where recruited but they were not screened until the previous patient was dosed and then only one at a time. This slowed down the whole trial. Calimmune eventually got FDA permission to screen in parallel. We should now be recruiting for the next cohorts but those patients won't have the final screening until each safety hurdle is overcome.

As I understand the process, our CRO and the clinical site recruit patients who volunteer for the trial. The initial tests, eg over 18 years, not female of childbearing age, etc., are carried out and names are put on a register. When the time comes, the CRO contacts the patients and final screening takes place, blood test etc.. Only those who meet all the criteria continue on and only when the DSMB says so. We should have our next candidate lined up just waiting the approval of the DSMB.

I cannot see any reason why UCSD could not be actively recruiting and getting names on our CRO's register. If there is a reason why they cannot do this, then it is that piece of information that I would have liked the company to have shared with shareholders.

This is not a major issue but we have had delays and knowing that two sites are recruiting would make it seem as if the process is likely to speed up. After all, if each of the 14 patients takes 14 weeks to recruit and each treatment is 6 or 10 weeks, just think how long the trial would take.