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pymadams

01/07/20 7:48 PM

#1204 RE: lenny_squiggy #1202

IMHO the trials are there to show that the procedure is safe, safe over time, and has benefits.
It seems to be safe. In particular the device they are now using was approved by the FDA.
In terms of safe over time the trial details talk about following each subject closely for 12 months and then less often for 5 years.
At the start of the trial it talked about improving vision, or suspending the decline. Now we are seeing some improvement consistently.

The trial started in 2015, it is scheduled to end by December 2020 (although LCTX just said speed up the last bunch of people).

At that point, We should know the initial benefits (I'm expecting that in May). Then the question becomes, do they really need to wait for another 5 years to check the last people to be treated, or will they look at the safety from the people treated at the start of the trial.

OpRegen has FDA fast track approval. If the benefits are clear enough, will the FDA approve this early? Will the stock price increase when people see the benefits, but before the FDA approval?