Everything NWBO is a slow walk - took over 12 years to do a 5 year trial, took ~2 years to spin the whole trial design and report a new topline (after the original primary endpoint failed), and another almost 2 years to file an application for commercial approval (after FDA Type B meeting told them don't bother filing in the U.S.). And now look how long the review process has been -- only explainable if they had multiple RFIs with the usual slow NWBO turnaround.
And also another trait of NWBO's bad management -- poor communication. They even have converted the company to being a contract manufacturer now to line the CEO pockets. Can't make this stuff up.
The only other explanation is that Northwest is intentionally dragging its feet on its recent RFIs.
Or raise questions regarding labeling. That alone can move approval out 60 days.
I don't think they dragged their feet on RFI’s…I believe they pushed forward as quickly as they could not knowing how long the process will be….Now, down to window of approval, if approval was received and you could save $10m in 30 days why not raise a question/clarification on the labeling?…Innocent and profitable.