IPXL thought they were smart to circumvent the FDA by filing for an alternnative site . This did not work and FDA dinged them the second time. Mgmt obviously dont understand the game rules. Annoy the FDA and they will hit back hard.
They got to get that Facility cleaned up wrt QA and QC with a minimum of events during a 6 mths period. I would recommend they subcontrat the QC oversight to a full time experienced consultant who is in the facility 24/7.
The trouble stems from a management team that is great at copying other drugs, but is a complete rookie when it comes to developing drug on their own... And it shows. I was flat wrong to bet on the mngt team. Yuck