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jimsgtx

01/17/16 8:54 PM

#249483 RE: volgoat #249476

“I know how the system works -- I know what mistakes you shouldn’t make, and I make sure you don’t make those mistakes,” Garnick says. “My view is the FDA is my friend. I am not an adversary.”

Garnick will be a huge part of the BLA submission... Maybe not write it, but it will most likely be written from his words.