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1234jklm

01/10/20 7:37 AM

#112409 RE: $Pistol Pete$ #112407

The fda has set out the requirements in the pre ind meeting with the company.’

Those requirements will be met, it’s taken years and huge amounts of time and effort to meet them.

The fda will most likely accept the application if it meets their requirements.

I think it’s clear they don’t submit the ind unless it’s perfect.