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lasers

01/09/13 9:32 AM

#48901 RE: rocky301 #48899

No where did GR say that it has been approved. They said that they filed.

"We late last year filed an amendment to our protocol to allow us to treat patients with 20/100 vision, that's down from hand motion 20/800 and 20/400 vision."

Until the FDA grants the amendment, ACTC must continue to select patients from the 20/400 pool for the Phase 1/2 trial 150K and 200K Cohort.

The Phase 1/2 trial is a safety trial NOT an efficacy trial. A 20/400 patient is considered legally blind so the FDA has allowed the safety testing.

A 20/100 patient still has hope that a new safe treatment will come along to help restore vision. The FDA will not risk an unknown treatment at this time.

After ACTC's Phase 1/2 clinical trial is completed there is a very good possibility that a new Phase 2B trial will be allowed to include 20/100 patients IMO.