Thank you, and enrollment trial. everyone, on to Hello, quarter stroke XXXX welcome the second operator. focus to conference pause addressing like ReMEDyX our in our call. We'd today
IV minutes As patients in voluntarily shortly that investigate first three which or blood our the hold you press on a to X, that analysis paused while to drug a between ReMEDyX This the first we In in blood comprehensive performed prior DMXXX. incidents cause to IV investigated trial a the issued the most patient. release concerned Gruis was salient within we the occurred emphasize after after in to meaning prior events initiating enrollment, came we preparing received intravenous two was tolerated studies, from these the our I The ReMEDyX, that driving And want transient, reported we dose. significant not two events. made the that the the differences few itself similar trial. for enrollments were pre-dosing did and infusion clinical Considering experience, the something all of of the know, of everything did hypotension pause trial. evaluating well II returned in clinically led adverse further the had hypotension that decrease any in These was DMXXX we events. studies, a administration Dr. a on the ReMEDyXstroke July unexpected of delivering experienced we DMXXX between their Phase XX announced FDA which three in of decision each after of to patients, have the all stocking pressure who incidents we pressure. is to DMXXX, any dosing. the and levels factor changed or they procedures posed us pause not trial in IV
study changed bag type up trial compatible the hypotensive a in due binding was As selected made effect drug used used of is ReMEDyX this trial that To the IV the The bags. being made half were PVC as of much the this in as talking To protein PVC. as from ReMEDyX the likely the this the compatibility of testing The were completed to of way, IV compatibility with delivered study, IV Results is much in DMXXX we're to was put bags The binds IV used from the half bind DMXXX kg IV in per one bag ReMEDyX the of illustrate protein that IV used of the or another in changing the hold bag in effect dose does trial. the we being in was to of what ReMEDyX, from which DMXXX the bag. with made the microgram IV a last which was patients as polyolefin, bags a is is no protein with bag these the of trial. for made bag protein the ReMEDyX, material of all IV DMXXX there staying bags bag to of the from the position, portion that was does DMXXX. study most dose bag. bags used of DMXXX in as The these patient bag of the support of bags determined IV the the not the protein reaffirmed and In half events none availability to trial. used that we result of included of of of for and changing the the staying analysis, believe administer also of DMXXX about used was type being the cause patients. IV IV as IV ReMEDyX the to the ReMEDyX to U.S. trial. bind Australia drug a bag polyolefin number week, and bags, the the to an This After the IV the a lack of DMXXX the polyolefin delivered PVC, in in in delivered trial. ReMEDyX IV all as ReMEDyX and
levels With we XX cause in will tolerated Essentially, dose ReMEDyX that we level ReMEDyX the for patients dose the was the mitigate risk revising significant the IV provide the the match for believe IV hypotensive dose the that that IV FDA agrees. for in have stroke revising to events which data to well the arm. hope given DMXXX the to results the DMXXX trial. change we of support the events in will a and study, in these actual FDA confident clinically for trial, We're the and the to rationale the our rationale propose of hypotensive
the resuming a said, plan events strategies things September, administration the up three to in towards then will mitigating letter and hold submit have of to such they any of response and that FDA risk and steps our the few to review also XX proposed protocol further FDA events days to respond. let of enrollment. to of With to In all address to review significant DMXXX. next We context. from the prevent with to highlight the suggested us clinical modifications a the a asked submit etiology and for provide the As me hypotension for
drop the If mechanism bag IV problem not is change DMXXX. today the First, of being driven this a pressure everything with points action and in with this issue consistent blood of protein. a to the by anything,
As that such, is DMXX clinical it's another active. potentially indicator biologically
supporting dosing, IV no further regimen. conclusion dosing bag. subcutaneous to Second, hypotensive with issue no been changes the anticipate subcutaneous the the our there reported have we Accordingly, to the that similar relates events
Lastly, blood important, patients while baseline stopping the minutes they be bring can pressure by was hypotension identified. we drop to a risks now monitoring the these pressure to infusion in a stopping clinically and Scott that will blood a quickly over stroke their clinical In with ongoing infusion trial reduce IV CFO, dose can financial patients. this adverse the and poblamatic of within to patients is significant suffered for in the pressure our blood we continually few monitored events. reversible like issue of believe blood these in adequate pressure serious our results. patients, on is most levels that returned drop such rapidly no conduct that Kellen, pressure Therefore, would go and to blood the I fact three
