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Re: tonecee post# 12805

Friday, 03/24/2017 7:50:41 AM

Friday, March 24, 2017 7:50:41 AM

Post# of 232336
Thanks- must have overlooked this.

The only thing that has me curious is the decision on BTD. That timeframe would put it at nearly 100 days from the application. I don't think the company can sit on that info as it is material.

Two possibilities (possibly 3)

1) FDA awaiting results of P3 Adjunct data and package approval together
2) FDA not satisfied with results but won't deny app but rather give some time to answer or correct questions.
3) FDA is just back-logged and gave Anthony a heads-up on the timeframe.

I'm hoping for choice 1 but it's probably choice 3.

Thoughts?

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