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Re: vinnie1965 post# 83704

Thursday, 06/07/2018 9:22:39 AM

Thursday, June 07, 2018 9:22:39 AM

Post# of 144815
Thats why they had a pre ind with the FDA


They know exactly what thefda require and they have taken a year to get that exactly right

And I'm sure they've checked in with the fdaaling the way if they had any doubts

Kw knows how good it will be to make an excellent impression with the ind and how much easier it will make the biological license. They are going to have a perfect ind submission imho.

The FDA might require extra information but it's highly unlikely they would reject the application. Not with the team of experts we have informing the process

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