MSB to dispute FDA finding in Type A meeting, page-214

Would be interested to see who MSB's advisors are on this one.

The Type A meeting will clearly involve higher ups at the FDA (who presumably had a reasonable degree of awareness of the issues involved in CRL-ing the application). But what pressure and influence can be brought to bear at other channels, parallel to and yes, even above the FDA?

I think it's safe to assume that MSB will be putting on the full-court press here, and that there will be an effort to lobby at the highest levels within and outside the FDA. Throughout my legal career, I have handled a number of cases that, at the local/operational level, seemed hopeless, but via lobbying (including via national level offices, and on a few occasions, international pressure through the embassies of my clients), suddenly turned around and ended in victory.

There are a ton of levers that can be pulled here.