For what it is worth... this is what I got back from IR after 3 attempts.
My Email
Why has the company been so silent about the upcoming FDA approved trials? Has the FDA put them back in a hold status. I would like to know why the timeline has switched so much in just a short period of time.
Response
I am responding to the email you sent Dan Schustack. The company is NOT on clinical hold, nor is it behind "schedule." There have been many questions from investors regarding the timing of the two multicenter Phase I/II trials that Advanced Cell Technology will be conducting in Dry Age-Related Macular Degeneration (Dry AMD), the leading cause of blindness in people over 65, and Stargardt’s Macular Dystrophy (SMD), a form of juvenile macular degeneration. The company believes that the activities in preparation for the trials will result in both trials commencing in the first half of 2011.
The company is currently in negotiations with four trial sites, and may add one to two more sites. There is extremely broad interest on the part of leading ophthalmology clinical centers, and the company is undertaking a very thorough evaluation of those entities that will be the company’s partners to ensure that the trials have the highest likelihood of success. Each trial is for 12 patients, set up in 4 cohorts of 3 patients. The company expects to begin both trials at approximately the same time, and under the protocols agreed with the FDA, the first patient in each trial will be treated (with the smallest dosage), and then 6 weeks later patients 2 and 3 in each trial will begin treatment. Advanced Cell currently expects to stage each set of cohorts about six weeks apart, with escalating dosages, so patient 4 in each trial would begin around 6 weeks after patients 2 and 3, and so on.
The company currently has sufficient cash on hand plus the availability of additional cash to more than cover the costs of the trials and the company’s other operating costs, though Advanced Cell is expecting to be eligible for grant, low interest loan and other non-dilutive forms of funding to assist in paying for the trials.
As each of the trials will be open-label, the company may, once the trials commence, be able to share details on the safety profile and response of the patients prior to the end of the trials. I hope this is responsive to your questions.
