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Re: Bjdev89 post# 18269

Monday, 09/26/2016 7:30:10 AM

Monday, September 26, 2016 7:30:10 AM

Post# of 38634

The FDA would have long ago intervened if it was an issue. That's the simple resolution to the whole discussion about blue dye. Not a chance it makes it this far if the blue dye was a problem. I say this as someone very familiar with the FDA.






Right. The NDA application couldn't have been filed in a timely manner if the FDA had any residual concerns about safety. Oh, wait a minute, uh oh, where is that danged application? 2 quarters past their own deadline and when bioequivalence was supposedly proven more than a year ago. What could possibly be the hold up??? Sorry, I forgot we are waiting for PODRAS patent approval so that NPODDDs can go forward, or was it bail out negotiations holding up the NDA?




Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)