Breakthrough Therapy: Navigating Regulatory Challenges

Got a call from our consultants. Said, "Listen here, my friend.

Your therapy's a game changer, the rule's about to bend. You need breakthrough

therapy, designation from FDA. Gets you to patients faster, shave off years

of delay." Started writing up our briefing book, 300 pages strong. Unmet medical needs,

substantial evidence, can't go wrong. Preliminary clinical evidence shows we're superior

to the current standard of care, baby. We're not inferior. Fast-tracked to approval,

breakthrough therapy's the way. Rolling submission, intensive guidance saved the day.

RMAT for regenerative medicine will fly. Accelerated pathway to the finish line. Oh my.