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Re: The_Bull post# 3963

Thursday, 12/13/2012 3:26:18 PM

Thursday, December 13, 2012 3:26:18 PM

Post# of 113818
Good stuff. 1st Q seems about right assuming the IND app doesn't need to be put on hold (if the company can't correct any issue within 30 days, app is put on hold). I read in the paper by the former FDA guy something like more than 80% of applications get some sort of feedback from the FDA. If companies do not hear from the FDA within 30 days of app submission, they are clear to move forward with trials - but that's rarely the case.

But if this company is as good as we believe, I don't believe this is a concern. But at least we know of potential setbacks.
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