RE:RE:RE:RE:RE:RE:"The reality is the boats are shaking" In early 2022, and pursuant to Ipen's initial approval of Onivyde in 2015, as a 2nd line treatment in mPDAC, Biden signed into law the IRA which determined that in drug development, biologics will be favored over small-molecule drugs because they have an extra four years of protection against price negotiations. While small molecule drugs will come up for negation nine years after FDA approval, biologics are protected from negotiations for 13 years. This also set into further motion the FDA's Accelerated Approval process for rare and orphan drugs, which were seen to be better served by gaining early approval on accumulated pre-clinical animal & Phase 1/2 human clinical data and in advance of longer term mortality data that is normally associated with common clinical trials. The consequence of this is that rare and orphan drugs can be granted Accelerated Approval prior to having a Phase 3 clinical study in place and fully enrolled.