G'day again Jen,
I think the problem is that people misinterpreted the "two week thing". The company did not say that they would get approval in 2 weeks, they said that they would have communication from the FDA in two weeks.
This ties in with information from other sources in that often the FDA asks for minor changes to documentation etc in the final stages of the approval process.
We can assume that they did receive such communication as Dr Rothel flew to the US to have a meeting with the FDA. The indication given at the AGM was that this visit was indeed to finalize such matters.
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