thank joining you, you Thank everyone today. And us for Nichol. again
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recent release, results QX. and briefly Just press to from go highlights and the the from over the
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and with having so been dialogue meetings, and forth. collaborative includes forth answers questions have submissions, This the ongoing with FDA. back and We
as the all bring have add all well some have to And that new of been to as working for We targeting data we Based very continues potential their revenue the to resubmission are of with in the collaborative we milestones, NDA. there. to discussion as development expecting a next that AZSTARYS royalty other on sales data the So to effort as weren’t generate QX that, Corium of is and we program AZSTARYS. now going year. KPXXXX know there. is continuing well. the early
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But So, the our them we shows the briefly, entire prior of has really, agency dialogue again are looking to this part since collaborative an continuing the some mentioned submission to have process, a to and been with of actually with this interaction I path do the been getting this completed and there that very I has FDA, CRO to were asset. at here. see as the believe of wanting the for resubmission, advancement these studies
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something we a is certainly is it feel that So critical piece.
as is well which like for as this as be for product. process may possibility by believe the some is new the really piece think request as it here. Looking choose choose a request we FDA raised didn’t through has always we not know an what any concerns. or that either we new at It actually an viable very efficacy generated We their work. FDA well CX said. that a KemPharm XXX% substance. Adcom everybody question that Briefly controlled have there the is should then. well, will as see is as new efficacy very treatment critical on been No additional the of there also of FDA still what this about actually new less XXXX, for any by guidance in than is particular has do And classification product looking far a our occurs you potential submission they been already there issues the narcolepsy. This rare hypersomnia what what this has disease, may path, And else been go potential And idiopathic from KP disease reviewing filings. mind, to the for identified, an serdexmethylphenidate, know, issues any but one is no hypersomnia regulatory this forward is, FDA well from previous appeal has as intended already It We has been is idiopathic to no dexmethylphenidate trial. designated delay the orphan as as I from than trial or narcolepsy. previous have since
inertia we Our more waking that as pathway the intended here potential exposure, provide IH, is providing that of addresses benefit fog. brain higher well including a sleep can waking symptoms as or major through
year. at an we indication. this Looking IND lead earlier our We next sit and stages where for what filed is this are, hypersomnia, idiopathic
We expect are to our so to the getting recruitment speed, trial be starting to end up forth. Everything to initiate well forward year. before there. look Phase of Sites the to enrolling, II going seems and
not we roughly next from top-line will next data, commercial We we particular add-on that that expect to data that a even are more perhaps have year. designation well second year, at and onto provide interim our this end before will as program. after Phase and in midyear as of II the narcolepsy, trial year we as in detail study After initiate looking time development data get we interim and primary underway case, study that by
Clifton company overall. So financial well where as provide details to I is the think of it status on LaDuane as position. the that and our both the to an turn going of update gives actually more development on to some programs over I’m
