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Don'tDrinkTheKoolAid

07/20/16 6:41 AM

#215884 RE: lasers #215881

So according to you approval in 2 weeks, yet Nasrat said they would meet with the FDA in a month sometime in August and discuss the issues in the CRL and what they need to do. Then execute a plan and then resubmit. Yet you have it approved in 2 weeks. So who is telling the truth you or Nasrat? Also when you go back and listen to the CC Nasrat says a label fix is not going to do it? I don't understand. You're saying change they're going to change the label and add instructions this is completely different than the CC I listened to.
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gman524

07/20/16 6:55 AM

#215888 RE: lasers #215881

Lasers

On the CC in August if where to hear of things not going well with FDA, is it possible to inquire if they WOULD or COULD start marketing Sequest Ox to other countries?
Or would they need FDA approval 1st?