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Re: pollyvonwog post# 113187

Tuesday, 01/25/2011 2:24:50 PM

Tuesday, January 25, 2011 2:24:50 PM

Post# of 257262
If Goldman is correct, it corroborates what I posted in #msg-59150780:

If a Major Deficiency letter rarely if ever happens, then as a practical matter a Minor Deficiency letter excludes almost nothing.

Surely, what MNTA was asked to do in 2007 was anything but minor. It took MNTA almost a year to respond to the FDA’s concerns and it then took the FDA almost two additional years to act on MNTA’s response.

p.s. Even if Goldman is wrong about what happened in 2007, I stand by the assertion quoted above.

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