I attend my 24-month eval/visit for CERE-120 on Wed of next week. I am full of questions for my PI. And I know that our PPP FDA Consultants, who are attending the meeting on Wed, will provide me with more questions to ask.
Air date: Tuesday, June 16, 2009, 2:00:00 PM
Time displayed is Eastern Time, Washington DC Local
I have read the RAC Meeting Minutes from Sept 2006, and had hoped to attend Wed with Tony and Arnie.
Of particular interest to me were comments:
- In the phase I trial...Regarding efficacy data, in the low dose cohort at 12 months, a mean 35% reduction in UPDRS-off scores was observed with evidence of persistence response in three of three subjects.
- For the high dose cohort at six months, a nearly 40% reduction in the UPDRS-off scores has been observed.
I will be re-consented again. The changes include: "After this visit which is month 24, there will be a month 36 and month 60. This will eliminate visits at months 42, 48, and 54. Phone calls will be made to you at month 30 and month 48. Also, the study will end at month 60 and there will not be annual visits thereafter. " (This also means that there will be no visits after month 60 for those that were treated...me for one...which were to be annual until death.)