While I am long and do believe this is a temporary setback- don't count on this just being a 2 day delay. IGXT basically had the same -CRL due to 3rd party manufacturing issues back on Feb 2014 and still have not been cleared. I realize OPKO may have more resources in getting this resolved quicker, but the point is the FDA seems to move at its own pace when it comes to these matters.
Hoping that things will get resolved sooner than later, but I am expecting something closer to 6 months. Good news is everything else seems to have been approved which should be the bigger hurdle to clear.
Frustrating that you would think the easy part of the process should be the manufacturing end. I realize this inspections are very stringent, but you would think this being Catalent's business they would have this nailed down. Same thing happened to IGXT back in 2014 and they ended up opening up the own facility, but have yet to move forward. Hoping that these issues are "small" fixes but they did state 14 observations so it will definitely take some time, plus the FDA moves at their own pace so we could be looking at several months to have this "re-reviewed".