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Content analysis
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Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
8th grade V bad
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New words:
abbreviated, aBLA, aboutanapproved, ACCA, acceleratedapprovalshouldbedistinguishedfrompriorityreview, accidentalinjuryor, acompanymaybeabletousethe, actionsandotherintellectual, activitiesinvolvethe, activitiesorclinicaltrialsmay, adecisionaspartoftheagency, adequateand, adequateto, adhere, adrugreceivingacceleratedapprovalperform, afindingthat, agenciesorgovernment, alreadyprovided, alsomayinvolvetreatment, anacceptablesafetyprofile, analyticaldatatotheFDAinourBiologicMasterFile, andaccurate, andadditional, andadverselyimpactourbusinessbyreducingourabilityto, andcontrolsforthe, andeffort, andforeignregulatory, andfuturegrowth, andmarket, andoptimal, andpracticesthatarelawfulinbusinessesoutsideof, andpurity, andsafety, andstateandfederalprivacyandhumansubjectprotection, andthatthetrialsubjectsare, andwasteproductsmay, anti, Anyadverseeffectsobservedaftermarketingofaproductcould, anycertaintyif, anyImmune, anyinterruptionsinthemanufacture, anyproductandwill, anyspecifiedtime, anythirdparty, applyregardlessofthepayor, area, areconductedinaccordance, arefoundto, asa, awardedpriorityreviewaregiven, awareofnewsafety, beconductedinaccordancewiththe, bedelayedinconductingour, beenanumberof, beestablishedthatcoulddelay, beforehumanclinicaltrialsmaybeginand, beheldliable, besubject, biologicalproductcontaininganactiveingredientnotpreviously, bytheoriginalPMAandmaynotrequireasextensive, canbecausethey, candidateswillreceive, cannotsell, cansubmit, carryouttheir, caseofbiologicsapproved, certaintypesof, cGMPand, changesfromthedevicecovered, clearanceorapproval, clinicaldataor, Clinicaltestingmay, clinicaltrialinvestigatorsmay, clinicaltrialprogramwillbeexpanded, clinicaltrialsbeforewe, clinicaltrialscouldresultinwithdrawal, clinicaltrialsintheirrespective, clinicaltrialsthatwerenotnecessary, closelymonitorstheprogressofeachofthethree, commercializationofDermaVirandourotherImmune, commerciallydistribute, compliancewithcGMP, complywithcurrent, compromised, conductPhaseIV, confirmthe, contamination, continuetoexpend, contractorstoenterintoconfidentialityagreementsthatprohibitdisclosureofconfidentialinformation, contractualdutiesor, controlsare, coststhatcouldmateriallyadversely, couldreduce, couldresultin, couldsuffer, credible, criminalpenaltiesand, currentlyrelyonthirdpartiestomanufactureandsupplyuswiththerawmaterialsthat, dataaccumulated, datafromthese, Delaysinpatientenrollmentcanresultin, designationand, designedtostimulate, designedtostimulatean, developmentofourproduct, directlyor, donotprotectintellectualproperty, donotsuccessfully, Dreamand, drugproduct, DSE, dueto, effectivelythan, enforcementauthoritiessuch, environmentallawsand, establishingthatthe, existingorfuture, exposedtoan, extendedbyFDA, failtoobtainsuch, failureofa, Failuretopromptly, fasttrackstatusmay, FDAapprovesaproductwhileacompanyhasongoing, FDAenforcementactionsinclude, FDAhasnotapproved, financialcondition, foragoodor, forapproval, forapprovalofour, forcomplying, fordurationsthatare, foreachseparatefalseclaim, forexample, forfuture, fororrecommending, forortoinduceeitherthe, forregulatoryapproval, forresulting, Geentic, generaterevenue, geographicallydispersedclinical, GoodLaboratory, hamperorpreventourabilityto, harborsdoesnotnecessarilymeanthat, hasaneffectonasurrogateendpoint, havenoproduct, healthinformationin, ifatall, ifmedicaldevice, ifthe, IIB, illegalorthat, immuneresponseagainst, improvementin, inclinical, includinggovernment, incorporateorbederived, increaseourdevelopmentcostsanddelayorprevent, indicationand, indicationfor, inexchange, intendedtherapeutic, Intheevent, inthefieldof, inthesubmission, introductionofthe, isoftensignificantly, issuesthat, Italsoispossible, kickbackandfalseclaimslawswhichmayapplytoitemsor, labelingandpackagingfor, licensinglawsunderwhichapatentownermaybecompelledtogrant, limitedpatientpopulationtoevaluatethe, litigationmore, liu, marketaproduct, materiallyadverselyaffectour, materialscouldharm, maycauseustoincursubstantialcostsandcould, mayexperience, maynotbeable, mayotherwise, Medicaidandother, medicineisfoundtobepotentiallyeffectiveand, mightsubmit, modificationsto, moresafe, mustbeapprovedbya, mustrelyonthird, necessarytoobtainclearance, neededtosupportany, needtobereplaced, noassurance, noprecedent, notbecompleted, notbesufficientto, notrelieveusof, obtainFDAapprovalto, ofanapplicable, ofanFDAinspectionofthemanufacturingfacilityorfacilitiesatwhichthe, ofany, ofanylegislation, ofapprovalforproductsapproved, ofbiologicsand, ofclinicaltrialsto, ofcomplex, ofDermaVir, OfficeofInspector, ofHealthand, ofourproduct, ofparticipating, ofsuchanaccident, ofthedata, ofthesame, oftheseraw, onaclinicalendpointotherthansurvivalor, oraccuracy, orapprovaloftheDermaPrepcomponent, orclarificationregardinginformation, orfor, orifthequality, orjudiciallyimposed, orregulatory, orsupply, ortheirsupplierstocomply, orunderwhatcircumstanceshealthcare, orwhen, otheraspectsofregulatorycompliance, otherin, otherproprietaryinformationoftheformer, Ourleadproduct, ourproduct, Ourresearchanddevelopment, ourtechnologiesin, ourthird, outsideof, partiestoconductourpre, patentorintellectualproperty, Penaltiesfor, personsfromknowingly, phasesofclinicaltrialsthatareconductedunderanINDandmay, placeasignificant, planand, possibleexclusionfromMedicare, postapproval, postapprovaltrialsofthebiological, preciselywithin, privacyof, productsawarded, productsbased, productsfor, productsonatimely, productsorproduct, Professor, prosecutionwill, prospectsmaybeadverselyaffected, providerswillprescribeor, publiched, raisedduringthe, receivepriorityreviewiftheyprovidesignificant, Reconciliation, referralofan, regulatedbytheCBERmay, regulatoryobligationsormeetexpected, reliance, reportingadverseeventsand, requestsforadditionalinformation, requirementsmay, resourcesinorder, respecttoanyofthese, responseagainst, resultinincreased, resultsand, resultsare, revealsafety, reviewgoalsbytheagency, revieworbytheadvisorycommittee, reviewwithinsix, rightsto, salein, sanctionsorother, scrutinybygovernment, servicesreimbursedby, setforth, significantdelaysinobtaining, significantfinancialresourcestoresearchand, significantlylonger, significantwaysandoftenarenot, sponsorfailsto, staffing, statuteinclude, studiesand, studiesmust, substantialcostsandbeadistractionto, successfullywithin, suspendorterminate, testedthusfar, testingmaynotadequatelydemonstrate, thanthose, thatanyof, thatdonotfully, thatthedataand, theadverseeffectsassociatedwith, theconvening, thefailureto, TheFDAhasbroad, theFDAortheEMAwillrequireustoconductmore, theFDAtodetermine, theinitial, themedicineforspecific, Therapyproduct, therehave, theresponsibility, theriskof, thesafetyandefficacyofthedeviceor, thesame, thesubjectsorpatientsarebeing, theuseoforwithdrawalofsuch, thevalueofthepatent, theymaynotprovideuswithadequateprotectionor, Thiscouldmaterially, toanappropriateadvisorycommittee, tocommit, toconduct, todocumentaclinicalbenefitinthe, toenrollpatientsinourclinicaltrialsasthepatientpopulationmay, tofit, tofurther, tohave, Tohelpprotectour, toinformation, toobtainregulatory, torequire, toseekpriorityreviewforDermaVirbutcannotguaranteethatthe, Tosupplement, totheperformancegoalofreviewingproductsawardedpriority, tothreetimestheactualdamagessustainedbythegovernment, transactionorarrangement, trialsareusedtogainadditionalexperience, trialscould, trialsfailto, typeofinformation, typicallybecauseitisusedbyagreaternumberandmorediversegroupofpatientsafterapprovalthanduring, unacceptable, Unauthorizedpartiesmayalsoattempttocopyorreverseengineercertainaspectsofproductsdevelopedbyour, uncertaintyexistsasto, underacceleratedapproval, underdevelopment, ustoincursubstantialcompliance, violationsofthe, Wearecurrentlydevelopingourregulatorystrategieswithrespectto, wearenotrelievedfromtheresponsibilityofensuringthat, webelievethatlegislationthatreducesreimbursementforour, wecannot, wecannotpredictthefulleffecton, wecurrentlyanticipatebeforetheywillconsiderour, Wedo, wefailtocomply, wehave, wemay, werelyon, whetherwithorwithoutmerit, whichbeganinJuly, whichdifferfromeach, whichregulatorypathway, whichutilizeanovelmechanism, willbe, withanyapprovedcommercial, withapplicable, withapplicableregulatoryrequirementscanresultinenforcement, withGCPtoestablishthe, withregulatory, workproductcould
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