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Post# of 91007
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karlm34

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karlm34

Re: LJ Silver post# 79517

Wednesday, 10/22/2014 3:17:34 PM

Wednesday, October 22, 2014 3:17:34 PM

Post# of 91007
I've been to FDA meetings.. research the process... it's all online on the FDA website, call them, ask.. they filed a pre-IND (Investigational New Drug Application). Process will be the same or longer for a biologic... claims and safety are #1 priority and issue with FDA.

Yes, there are laws that say they must respond to you in a certain amount of time, but all they need to do is say we will respond to your request within x # of days, but first submit this, submit that, etc... FDA is backlogged
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