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lasers

05/28/16 9:09 AM

#202276 RE: KravMD #202273

Perhaps if you have an example case that you know of you could post for discussion. As for SequestOx, it has has been so thoroughly discussed with the FDA, no questions remain.

no2koolaid

05/28/16 9:18 AM

#202278 RE: KravMD #202273

While I did a cut and paste of the relevant FDA document, given your nom de plume, you might want to peruse the entire document...

http://blogs.fda.gov/fdavoice/index.php/tag/priority-review/

There is a 2015 document but they did not address the same issues. However, we know the FDA is pressing to improve their processes even absent the issues on opioid abuse. I am no medical expert, my knowledge lies in business strategy. However, the events in the external environment are critical to understanding and assessing the opportunities a firm may have. So it is that I pay attention to the threats (all part of a simple SWOT).