FDA PMTA problems have been going on for years

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zoiDman

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nicnik

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My understanding is that it hasn't been "denied" but the application was insufficient, and they are welcome to continue the application process.
My understanding is that any denied application can be redone and resubmitted.

If I'm mistaken, it sure wouldn't be the first time.
 
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zoiDman

My -0^10 = Nothing at All*
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My understanding is that any denied application can be redone and resubmitted. ...

Sure.

Just keep throwing Money Down a Hole until the FDA Tells you the Hole is Full. Or you Run Out of Money.

Whichever comes 1st.

;)
 
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