Heather Prichard

“Ryan, yes, as Laura stated, we completed our pre-license inspection of our manufacturing facility and had a very successful outcome. And based on the outcome of the inspection and all of the other FDA interactions on the whole, we remain very confident in the approval of the HAV in vascular trauma.”

“So, where we stand right now with the coronary bypass program is that we continue to do our primate IND-enabling studies with primates, and we're continuing to do those through the remainder of this year and gather data for the IND, the preclinical part of the IND for - that we still expect to file in 2024.”

“From a manufacturing standpoint, we are on track, as you know, to be able to produce our product for commercialization. We don't anticipate any complications, but we continue to prepare for our preapproval inspection and also update our modules for our BLA filing.”

“Certainly, from an R&D expenditure point of view with – we expect that to be relatively constant throughout the year.”

“What we're predicting, as Laura said, as our sampling rates are somewhat higher now, but we predict that in commercial year one or two to have it similar to other biologics products.”