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rocky301

01/09/13 9:46 AM

#48905 RE: lasers #48904

when the clinical trial site IRB's all approve you will see it there. ACT chose the underlined option below.

So in terms of upcoming milestones for these trials, we've got a total of 36 patients to treat in these three Phase I trials, 12, 12 and 12. But what we really want to do now, and we just actually last weekend had a kind of a getaway with out clinical investigators and members of our Independent Ophthalmic Advisory Board, and what we really wanted to get to was how is the best way for us to go about starting to treat earlier stage patients. Should we hop into a Phase IIA trial and power it with more data and see if we can start looking at what happens when you treat 20/100 or 20/80 patients, or should we just go in and try to change the protocol to include earlier stage patients in our Phase I trial?
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2020

01/09/13 12:48 PM

#48946 RE: lasers #48904

In a recent Stem Cell Conference one of the Eye Surgeons associated with the trials said that the FDA had approved a protocol change. Why would he say that if he didn't know. Perhaps ACTC has been notified of the change but it hasn't appeared on the FDA site yet.