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biosectinvestor

02/22/22 6:56 PM

#445976 RE: hyperopia #445966

Hi Hyperopia,

I don’t interpret that language that way. The micro den is a general system, it almost certainly would need to be somewhat customized but the system core functions would be the same, and the processing versus the manual manufacture is not likely substantially changing.

But more importantly, I say what I say because that is what the FDA says. There likely will be no requirement for human testing at this stage in terms of comparability. It will likely focus on other more easily provable measures.