September 18,2008

I am really getting nervous about this whole thing. If you have read Nick's story and all the updates you should be caught up by now. Because Nicholas is Nicholas, the doctors have been unable to get his cornea thickness measured so therefore it is still questionable to whether or not he is a Candidate. With this CXL procedure, doctors do not sedate the patient so therefore, No doctor wanted to deal with Nicholas- NOT even the doctor in Europe. We are very grateful that Dr. Stulting and the Emory team want to be involved in our situation. Nicholas got the worst thing that ever happens to a cornea patient (Hydops). It was a crisis situation but now it is over and has left a scare on his right cornea. As of today the plan is: When the Institutional Review Board (IRB)of Emory approves the compassionate waiver then it is sent to the FDA. On July15 I wrote Senator Isakson to get in touch with the FDA about this situation and on July 19, David Bands from Washington FDA called me and said that it was not going to be a problem to get it through. Today, I got an update letter that you can read below. The plan is to put Nicholas under sedation and do a cornea transplant in the right eye and the CXL in the left eye. (It is said that if we do not get the cornea transplant in his right eye it will keep getting worse.) thanks for caring Nick's mom Janis: Our Amendment to get compassionate use is under "expedited review" as of 9/16/2008. I truly cannot speak to when we should have approval for that, as it's the IRB that moves this along, but it does appear that our original estimate of having IRB approval by late October still appears to be in the cards. It still remains possible that they would have questions before granting approval, and we will move quickly. BUT - Once that is approved, I am sure either myself or someone from the study will be in touch to schedule the next step. I remain happy to answer any questions you have, and I'll let you know if anything changes before our anticipated approval. Paul Larson Emory Eye Center