MSB to dispute FDA finding in Type A meeting, page-102

Legally, there don't seem to be too many options for MSB.

There is a statutorily-prescribed dispute resolution mechanism for FDA decisions, and you have to follow it to the letter. Otherwise, no standing to sue.

So FDA issues CRL? MSB can respond to the CRL as dictated by statute, including via requesting a Type A meeting, reapplying, walking away, or trying to comply with the additional demands in the CRL.

I assume at SOME point, there will be a final decision that could be appealable to Court (likely, I suppose, after the further trial requested by the FDA was done, but the application was still not granted), but again, there may not be, so long as the FDA has STILL NOT rejected the application - only put forward FURTHER additional requirements to prove it works. Eventually, you would likely have an argument that it is acting unreasonably and you have a de facto rejection, but I don't think MSB is there quite yet (and may never be).

Remember, too, that the ODAC is only an "advisory" committee (it's right there in its name!), so the FDA does NOT have to abide by its decision one way or another, so I don't see a court forcing the FDA to do so, either.