any news today?, page-59

totally agree Southoz, what a mess, here we have QRX telling the market in November the FDA cofirming the 008 study satisfied efficacy requirementss and there were no safety issues and on the 9th October 2013 QRX states:

"The FDA reaffirmed that the safety and efficacy of MOXDUO are not at question"
Doesn't that suggest the FDA agrees that MOXDUO is a safe and effectve product and thus likely to gain approval?

The only noted problem was the time discrepencies.
When in actual fact the FDA viewed the data provided no safety or efficacy advantages to warrant approval throughout the whole application process.

The question is how can QRX make these statements to the market?
Has QRX misinterpreted comunications they have had with the FDA, has QRX been negligent in their communications to the market and held the full details in that although MOXDUO is safe and effective it hasn't satisfied the FDA that it has enough advantages to be gained approval?
or has the FDA mislead QRX? who is to blame?