I've been through the expedited designations quite a few times...

I've been through the expedited designations quite a few times and done the deeper dive backgounding to assess the details -- and it's involved and intensive -- and the different designations come in an escalated scale of requirements...
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
and that's where the Healey and Berry connections are vitally important - Herb Brinkman /Sabrina Paganoni as well - e.g.

• taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment

• assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
  • involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review

We seem to meet the requirements.
And we have the right people in place.
Ice