Power of The Dream Ventures 10K 2012 Annual report | PWRV Filing

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New words: AAFP, ABBOTT, abbreviatedreviewgoalsbytheagency, abilityto, abletoretainorrecruitqualifiedofficersanddirectorsto, absence, Abstract, abuse, academic, acceleratedapproval, Acceleratedmarketingapprovalisreservedforaproductthatdemonstratesameaningfultherapeuticadvantageover, accuratelypredict, ACTG, actingaloneortogetherwiththeircollaborative, activitiesinvolvingthe, actualdamagessustainedby, Actwhichapplyto, adequatealternativesto, adescriptionofthe, adjuvant, administered, administrativeorjudicially, adoptionoftheproductswouldbeimpaired, adverseeffectonourfinancial, adverselyaffected, advisorycommittee, advisorypanelofexpertsfromoutsidetheFDAmaybeconvenedtoreviewandevaluatetheapplicationand, AE, AEs, affectourabilityto, affinity, Africa, Afteradeviceisplacedon, afunctional, againstlossesarisingoutof, againstlossesmaynot, age, agenda, albeit, Aldesleukin, Aldevron, alfa, allergic, allergy, alliance, Allofthoseinvolvedin, alpha, alreadyprovidedinthesubmission, alsomaysubmitaformalRequestfor, Alternativetechnologiesarebeingdeveloped, amalignanttumor, American, Amgen, amountoftimingorresourcestheydevotetoourprogramsorthequalityoftheirperformance, amplified, amplify, analyzed, analyzing, anchoring, andanysubsequentprotocolamendmentsmustbesubmittedtotheFDAaspartoftheIND, andapproval, andcompletionofclinicaltrialsmaybedelayedorsuspendedby, andcontrolsareadequateto, andethicscommitteesbasedon, andFDAandotherapplicablelawsand, andFDAapproval, andFDAapprovaltocommercialize, andFDAauthorizationby, andFDAcouldtakeenforcementaction, andFDAdeterminesthatourpromotionalmaterialsortrainingconstitutespromotionofan, andFDAisauthorizedto, andFDAmarketingapprovalofaproductcandidate, andFDAregulationsandguidanceareoftenrevisedorreinterpretedbytheagencyin, andfutureprospectscould, andimplementingmanufacturingmethodsandbuildingapilotcGMPcompliantfacilityinHungaryto, andin, andindustry, andmanagement, andmarkettheseproductscouldsuffer, andmaybeapproved, andMedicaidreimbursementpoliciescanalsoinfluencecorrespondingpoliciesofprivateinsurersandmanaged, andoperationofqualitysystemstocontrolandassurethequalityof, andothercontractorstoenterintoconfidentialityagreementsthatprohibitdisclosureofconfidentialinformation, andpackagingfor, andproceduresandtheimplementation, andsellourproduct, andtransmissionof, andwhichmayresultinissuedpatentswhichour, animal, anin, antigen, ANTIGENeered, ANTIGENeering, antiretroviral, antisense, antiviral, Anumberofcompaniesin, Anyactionagainstusforviolationof, Anyadverse, anycertaintyiforwhenwe, anyitemorservicesforwhichpaymentmaybe, Anylossorlimitationsonusewithrespecttoourrighttousesuchintellectual, Anyof, anyofouroperationsarefoundtohaveviolatedorbe, anyofourpendingorfutureapplicationsareissued, anyoftheseactionsweretooccurit, Anyoftheseproceedingscouldresultineitherlossof, Anysuchinterruptionwoulddisruptour, applicablecountry, applicationbecausetheBLAor, appln, applyregardlessof, approvalateachclinicalsite, approvalisrequiredforeachproposedindication, approvalof, approvalofa, approvalprocessmayincludealloftherisksassociatedwithobtaining, approvalprocessmorecomplexandcoulddelayapproval, approvedby, approvedbytheFDA, approvedfor, aproductwhileacompanyhasongoing, Aprotocolforeachclinicaltrial, arealsorequiredto, areawaitingmarketingapproval, areex, Argentina, arm, arrested, art, AsofDecember, assay, assert, assessmentbythe, Assumingsuccessfulcompletionof, assureyouthatourproductcandidateswillbereviewedorapprovedmoreexpeditiouslyfortheirfasttrack, asthma, atopic, attentionof, Atty, Aug, Australia, authentic, automatic, aware, background, bacteria, bankruptcy, barring, Basedonthose, batch, battle, beadequateifclaimsarise, beavailableatalloroncommerciallyreasonabletermsorwe, becertainthatoursearchforsuchpersonnelwillbe, becomeeffective, beforethe, beginand, beinitiated, bemateriallyadverselyaffected, bereviewedinashortertimeframe, Berlini, Bethesda, billion, bind, Biochemistry, biodistribution, biographical, biologic, biological, BiologicalproductsmustsatisfytherequirementsofthePublicHealthServicesActanditsimplementing, biology, biomarker, Bionor, Biopharma, biophysical, Biotech, BLA, BLAor, blocking, blood, Bluestar, BMF, body, boost, boosted, booster, boosting, Bothex, Bourinbaiar, Brazil, Breakthrough, bridge, broad, broadened, broadest, broughtunderhealthcarereimbursement, buffering, butdonotcarryproductliabilityinsurance, byin, byreducingourabilityto, bytheopinionoftheadvisorycommittee, bytheoriginalPMAandmaynotrequireasextensiveclinicaldataor, bytherapidpaceoftechnologydevelopment, candidate, candidatenottobecommerciallyviable, candidatesunderthejurisdictionofonlyonecenterwithinthe, canin, canoccurat, canresultin, canrevokefasttrackstatusatanytime, capableofproductionata, capacity, capture, captured, care, carefully, cargo, Caribbean, carrier, CBERandthattheDermaPrepmaybe, CDRH, CE, cell, cellsin, cellular, center, CertainclinicaltrialsforDermaVirwillbeconductedinEurope, cervical, cervix, cessation, CFS, cGCP, cGMP, Chair, Chamber, chance, changeswillbeenactedor, characteristic, cheaper, cheapest, chemistry, Chicca, children, China, Chiron, ChlamyDerm, Chlamydia, chosen, chronic, chronically, clade, Claimaction, clearance, clearanceorapprovalofproductmodificationsthatcouldsignificantlyaffectsafetyorefficacyorthat, clinicalapproacheswillresultinproductsthe, clinicalbenefit, clinicaltrial, clinicaltrialdata, clinicaltrialinvestigatorsmaybedelayedinconductingourclinicaltrialsforreasonsoutsideof, clinicaltrialorcommercialsalesorthetemporaryorpermanentclosureofafacility, clinicaltrialsbeforewecansubmitaBLAwithrespecttoanyof, clinicaltrialscouldresultinwithdrawalofapprovalforproductsapprovedunderacceleratedapproval, clinicaltrialsinaccordance, clinicaltrialsmay, clinicaltrialsto, clinicaltrialstoverifyandfurtherdefine, closelymonitorstheprogressofeachofthethreephasesofclinicaltrialsthatareconductedunderanINDandmay, closer, Cluster, CMA, CMC, CMO, cohort, collaboratormaybelimited, combinationproductsisoftenmorecomplexandmoretimeconsumingthanthereviewofaproductcandidateunder, commercializationeffortsfor, commercializecertainpotential, commercializedanyof, commercializedproductsin, commonly, Companiesalsomayseekfasttrackdesignationfor, comparabilityforeachmanufacturingsite, comparison, competitiveadvantageagainstcompetitorsthatdevisewaysof, competitor, compromiseddueto, computerized, conductclinicaltrialsasplannedor, Conference, confirmed, conformityvariesdependingonthetypeandclassofthe, consortium, constitute, constitution, consumingforusorathirdpartytoimplementandthatmayincludethetemporaryorpermanentsuspensionofa, consumption, convenienceorclinicalorotherbenefitsfora, conveniently, conventional, convicted, copyright, corneum, correct, correlation, corresp, costly, costsinoureffortstosecurenecessarygovernmental, couldadversely, couldbedifficultorimpossibletofind, couldbesubjecttoadministrative, couldresultinsubstantialcostsandbeadistractiontomanagement, count, criminal, crucial, Cuba, cultured, cumbersomeex, cumulative, cure, Curie, currentlydiscussingthepotentialregulatory, currentorfutureproductsinfringe, cycle, cytotoxic, daily, danger, datamayalsolimittheapproved, Datamonitor, deal, dealer, debenture, decree, dedicated, deem, deemed, default, defense, degradation, delayedclinical, Delaysin, Delaysinobtaining, demonstratethatthenewrawmaterialwill, Dendreon, dendritic, denied, DermAll, DermaPrep, DermaPrepbeyondcurrentclinicaltrialsonacceptabletermsandatcommercially, DermaVir, DermaVirfromthe, DermaVirsuccessfully, describedaboveoranyother, desirable, desire, desired, detailedinformation, developingcommercially, device, deviceoroneofoursimilar, devoted, diagnosed, diagnostic, died, dietary, Diosd, DISCOVER, discovered, discovering, discovery, disease, distant, diverted, DKFZ, DNA, Docket, doctor, domiciled, donotprotectintellectualpropertyrightsto, dose, dosing, doubled, Dr, driven, dropping, drug, DrugAdministration, DTH, durability, durable, duration, duringthe, Duringthereviewperiod, dust, duty, EA, eachsiteatwhichthe, Eastern, eCTD, educated, effectcoulddelayorterminatefurtherdevelopmentandhamperorpreventregulatoryapprovalormarketingofourproduct, effector, effectsobservedaftermarketing, efficacy, efficacyof, Egg, EITF, electronic, electronically, electroporation, elicit, eligible, EMA, embed, eMINER, encoded, encoding, encounterdifficultiesorunanticipated, endosomal, endosome, endpoint, enforceableandwewere, Eniko, enjoining, enrolled, ensureapproval, ensurethe, entitlingustoindemnification, env, environmentforbiopharmaceutical, envision, epidermal, epitope, Epzicom, eradication, errorscaused, erythema, escalation, escape, ESPRIT, essential, establishmarketingandsalescapabilitiesinternallyorhireasufficientnumberofsalespersonnelwithappropriate, establishthe, Esteve, EU, EudraCT, EURO, Europethe, Evenif, Evenifacceleratedapproval, Evenifthe, Evenifwearesuccessfulindefendingagainst, Evenifwecomplywithall, Evenifwereceiveapprovalto, eventofanimpermissible, eventreporting, everyday, excellent, excipient, excluded, exempt, Existingorfuturecompeting, experimental, experimentally, expertiseofanyofourkey, expertiseto, expiry, extenttowhichDermaViroranyofourother, extra, facilitatethedevelopmentandexpeditethereviewofproductsintendedforthetreatmentofseriousor, facilitiestosupplytheAPIandthe, facility, facilityinvolvedwiththepreparationofour, facilityorfacilitiesatwhichthe, failtodelivertherequiredcommercial, fast, Fasttrack, fasttrackdesignationoracceleratedapprovalorwillawardtheBLApriorityreview, fatigue, FDA, FDAcenter, FDAmaywithdrawsuchapprovalif, FDAofaBLA, FDAraisesconcernsorquestionsaboutissuessuchastheconductof, FDAultimatelymaydecidethattheapplicationdoesnotsatisfytheregulatorycriteriaforapproval, FDAwillinitiallyreviewtheBLAforcompletenessbeforeitacceptstheBLAforfiling, fear, FED, femtosecond, fertility, fiber, FIBERSCN, figure, financialconditionmaybemateriallyadverselyaffected, findoneor, finishedProduct, fit, followingin, food, foot, forany, forapprovalofourproduct, forbearance, forecast, foregoing, foreignjurisdictionswe, Foreignstudiesperformed, forhealth, foritsintendeduse, forma, formand, format, formation, formulated, formulation, fororto, foruseorplaceother, foundto, fowl, Franco, fraud, Fraunhofer, frequency, furtherdefinethesafetyandefficacyof, Gaenslen, gag, gamma, ganglioside, Garcia, gathered, Genexine, genital, Gentic, GenticImmunity, GenVec, German, Germany, GI, GLP, GMP, Goettingen, Goldstein, governmentinvestigationsandenforcementactionsinvolvingmanufacturerswhoallegedlyofferedunlawful, Governmentregulationsinthe, Grazax, groupofpatientsafterapprovalthanduring, grow, growing, GTU, guide, gut, Gyor, HAART, hamper, Harald, harbor, harboring, hasaneffect, Hausen, Havanna, havedevoted, havemodifiedourdevicessincetheyreceivedtheFDAclearance, haveviolatedthe, Head, healthcare, healthcarefraudandabuseandpatientprivacyregulationandenforcementbyboththefederalgovernmentandthe, healthcareproviderswillprescribeor, healthin, healthy, Heidelberg, helper, hematology, Hemispherx, herewith, Hero, heterosexual, highlight, Highway, hireandretainskilledemployeesinatightlabormarket, HIVpositive, HLA, house, HPV, HuPaDerm, hurt, hyperchromicity, hypersensitivity, IAVI, Ib, Ifanentityisdeterminedto, ifapplicable, ifmarketing, ifmedicaldeviceclearanceorapprovalisrequiredatall, Ifourcollaboratorsweretoassistourcompetitorsatour, Ifrequiredby, ifsuch, ifsuchrecallistheresult, IftheFDAdoesnot, IftheFDAweretodisagreewithanyofour, ifwe, Ifweareunabletohireandretainskilled, Ifweareunabletopreventunauthorizeduseordisclosureofourproprietarytradesecretsand, Ifweenterintocollaborativearrangementsforthe, Ifwefailtocomplywiththe, ii, IIa, IIclinicaltestingona, iii, IJP, illegal, illnessesandthatprovidemeaningfultherapeuticbenefitoverexistingtreatmentsmayreceiveacceleratedapproval, illustrate, immaterial, immigration, immuneresponseagainstHIV, Immunitor, Immunodeficiency, immunogen, immunogenic, immunogenicity, immunological, immunologically, immunology, immunotherapeutic, immunotherapy, impactusorourcollaborationpartnersby, implantation, implied, Importantly, imposeduponusor, imprisonmentorexclusionfromgovernment, inability, inactivated, Inaddition, Inadditionto, incidence, inclinicaltrialsor, includeallof, includeInstitutional, incorrectlydesignor, increaseddevelopmentcostsanddelaysinregulatory, increaseorchangeasaresultof, increasingemphasison, incursubstantialcompliancecoststhatcouldmateriallyadversely, IND, indebted, indemnify, India, indicationforwhichthedesignationwasreceived, indirectlybesubjecttovariousfederalandstatelawspertainingtohealthcarefraudand, induce, induced, induction, industriesisintenseandhasbeenaccentuated, inexpensive, infect, infected, infection, inflammation, informulatingthedevelopmentstrategy, Infrequent, infringing, infusion, inhibitor, inhibtor, injected, innovative, Inovio, inpatientenrollment, inquiry, inserted, insertion, inside, inspectionforcompliancewiththeapplicableregulationsasaconditionofFDAapprovalofDermaViror, insufficient, insufficienttoallowapproval, insurance, intangible, integrase, intellectualproperty, intendedfor, intendedtherapeuticindicationand, intendtoseekfasttrackdesignation, intensification, intensify, intensifying, interference, interferon, Internationalsalesofbiologicalsubstancesandmedicaldevicesaresubjecttoforeigngovernment, interpretationsofpatentlawsmayalsodiminishthevalueofourintellectualpropertyornarrowthescopeof, inthe, intheareaofproductionandqualitycontrolto, inthepharmaceuticalandbiotechnology, intracellular, intrinsic, introduced, inverse, inviolationofanyofthelawsdescribedaboveand, ionic, IR, IRB, irreversible, iscompleting, Italy, itmoredifficultfor, iv, IZI, Jan, Jerant, Julianna, jurisdictionaldeterminationsarenotbindingon, key, keypersonlifeinsurance, kickbackandfalseclaimslawswhichmayapplytoitemsorservicesreimbursedbyanythirdparty, kill, killer, killing, Korean, lab, labeling, labelingregulationsandFDAprohibitionsagainstthepromotionofproductsforuncleared, Labor, laboratory, landscape, larger, laser, lawsisincreasedbythefactthatmanyof, lawsuit, led, legislativeandregulatoryproposalstochangethehealthcaresysteminwaysthatcould, Leipzig, letterwilloutlinethedeficienciesandprovidetheapplicantwithanopportunitytosubmitadditionalinformationor, leukemia, leukocyte, Levente, liable, liableifseriousadversereactionsfromtheuseofourproductcandidatesoccureitherinclinicaltrialsorin, licensesto, life, Ligetszepe, limitednumberofsubjectsasdescribedbelow, limitingthegeneralityof, lipid, lipopeptide, Lisziewicz, localethicscommitteeandin, locatethirdpartiesthatcan, logistic, logistically, Lori, Luc, lymph, lymphoid, macaque, macaquesex, madeinwholeorpartunderfederal, madeunderafederalhealthcareprogramsuchasthe, MAGE, mailing, maintaincompliancewithcGMPandotheraspectsofregulatorycompliance, maintaincompliancewithQSRandotheraspectsofregulatory, maintainsufficientinsuranceasapubliccompanytocoverliabilityclaimsmade, makeadeterminationregardingsubstantialequivalence, makeclaimsofsuperiorityovercurrentlymarketed, makemanufacturingchangesto, makepubliclyavailablecertain, makingcompetitiveproductswithoutinfringingany, makingfalsestatementsinconnectionwiththedeliveryoforpaymentforhealthcare, malfunctionedinawaythatwouldlikelycauseorcontributetoadeathorseriousinjuryifthemalfunctionofthedeviceorasimilardeviceweretorecur, malfunctionedinawaythatwouldlikelycauseorcontributetodeathorseriousinjuryifthe, malfunctionofthe, managedcarein, mannose, mannosylation, manpower, manufacturedex, manufacturedin, manufacturedthefinalDermaVirproduct, manufacturerandathirdpartyassessmentbya, manufacturersmustcontinue, manufacturethefinalproduct, manufacturingfacilitiesdonotsatisfytheregulatorycriteriaforapproval, manufacturingprocessesare, manufacturingstudiesandsubmitthatdata, Mark, markdown, marked, marketingapproval, marketingbutmayalsoapprove, marketingoforwithdrawapreviouslyapprovedproductfromthemarketupon, marketingtodatehasrequiredpremarketapproval, marketourproductsin, marketthe, Maryland, MaterialviolationsofcGMP, mating, maximal, maydecideafterreviewthatourdataare, mayexperiencealongerregulatory, mayexperiencesignificantdelaysinobtaining, mayfileinthefuturemayhaveclaimsnarrowedduring, mayhavetoundertakecostlylitigationtodefend, maylosevaluable, maynotacceptthe, maynotbeableto, maynotcurrentlybeor, mayoffercomparable, mayotherwisenotbesufficientto, mayultimatelyissuewithclaimsthat, MD, meansofanapprovalorclearancepriorto, mechanism, median, medicaldeviceforclinicaltrialsorcommercial, medicaldevicesaresubjecttounannouncedinspectionsby, medicinal, medicine, medicineintohumansubjectsto, medicineisfoundtobepotentiallyeffectiveandtohaveanacceptablesafetyprofile, meetdemandfor, meetexpected, melanoma, men, mentioned, Merck, methodsdonotexist, methodsweemployin, mg, mice, microscopy, mightsubmitaBLAforregulatoryapproval, migration, mild, mimic, mine, mite, modern, modificationsthataffectthesafetyoreffectivenessofthe, modified, modify, modifying, molecular, Molnar, monitor, monitoring, monkey, Montagnier, morbidity, moreacceptable, moreestablishedthanweareandhavetheabilityto, morelengthyandcostly, moreofourproductcandidatesfor, moreoftheclaimsof, moresafeharborsdoesnotnecessarilymeanthatitisillegalorthatprosecutionwillbe, mortality, movement, mRNA, MTD, murine, mustbe, mustsubmitapremarketnotificationdemonstratingthatour, mustsubmittothe, mutant, nadir, naked, nanoformulation, National, NCT, necessaryapprovalsforourfutureproductswouldadversely, necessity, needle, nef, Neisseria, network, newfederalcrimesforknowinglyandwillfullyexecutingaschemetodefraudanyhealthcarebenefit, NewPMAsorPMAsupplementsarerequiredfor, NIAID, NIH, Nile, nineteen, Nobel, node, nominated, nominating, noncompliance, Noneofourproductcandidateshavebeenapprovedby, nonspecific, notbe, notifed, NotifiedBodyinonecountrywithinthe, notpreviously, notprovideanadequateremedyin, nowpendingofwhichweareunaware, nuclear, nucleic, nucleotide, obligationsthatmaylimit, observe, observed, obtainedfromagroupwithinthe, obtainFDAapproval, obtainthe, obtainthenecessaryrawmaterialsor, occurrence, ofadequate, ofanFDAinspectionofthemanufacturing, ofanyapprovedcommercialproductscouldbesuspended, ofanylitigationcouldhavea, ofapproval, ofaproductcould, ofbiopharmaceutical, ofcomplexpatentorintellectualpropertylitigationmoreeffectivelythanwecanbecausetheyhave, ofconformitywiththeessentialrequirementsforaCEmarking, offense, ofnew, ofPower, ofpreclinicallaboratory, ofproductsbasedonourtechnologiesin, ofproductsdevelopedbyour, ofsuchan, ofthe, oftheBLAforfiling, ofTia, oligonucleotide, OMP, onaclinicalendpointotherthansurvival, onasurrogateendpoint, onatimelybasisandatcommercially, Onceimplemented, ondiscussionswiththeFDAwebelievethatthebiologiccomponentofDermaVirwillbereviewedby, oneof, oneor, oranyotherproductcandidate, orbytheadvisorycommittee, orbytheFDA, orefficacy, orin, orincreasing, orjudicially, oronthebasisofaneffect, orotherthirdpartiesmayassertthatourproductsandthe, orpreventregulatoryapprovalofourproductsunderdevelopment, orrestrictsmanyarrangementsandpracticesthatarelawfulinbusinessesoutsideof, orthe, ortheirsupplierstocomplywithapplicableregulatoryrequirementscanresultinenforcement, orunderwhat, otherskin, otherwiseandspecifiessuch, otherwiseenjoy, ourabilityto, ourabilitytocommerciallydistributeandmarkettheseproductscouldsuffer, Ourabilitytogenerateproductrevenueswillbediminishedifourproductssellforinadequatepricesor, ourbusinessoftheimplementation, ourclinicaltrialsfor, Ourfacilitiesandqualitysystemsand, ourin, Ourinabilitytoobtain, Ourleadproductalsoisacombinationproductandincludesanewmedicaldevicethatmayrequiremedical, Ourproductcandidatesrequire, Ourproductcandidateswillremainsubjecttoongoingregulatoryrequirementseveniftheyreceive, Ourproductdevelopmentprogramsdependuponthirdpartyresearchersandwecannotcontrolthe, ourproductsandlabeling, ourproductsandwe, Ourpromotionalmaterialsandtrainingmethodsmustcomplywith, Ourproposedproductscouldbe, Oursuccessandabilitytogeneraterevenueorbe, Papilloma, paradigm, parallel, parameter, parasitic, Parma, patch, patentsthatoneormoreofourproductsorpartsmayinfringeandof, patentsthatweownorhaverightsto, pathogenic, pathwayforDermaVirwiththeFDA, patient, patientsareunabletoobtainadequatereimbursement, Pavia, payorsincreasinglyattempt, payup, pDNA, peer, PEIm, Pennsylvania, people, peptide, Perenyi, performedbyqualified, periodicstatusreportsto, permanently, persist, personnelcouldresultindelaysinproduct, personnelortheirworkproductcouldhamperorprevent, ph, Pharma, pharmaceutical, pharmacologic, pharmacy, PHPC, physical, physician, pigment, pill, pilot, pipeline, pivotal, placebo, plasma, plasmid, play, PMA, PMAapplicationmustbesupported, pol, policiesforanyof, polyclonal, polyethylenimine, polymer, pool, pooled, popular, population, portrayal, possessed, possiblyretrenching, Poster, potent, PotentialFDAenforcementactionsinclude, preciselywithinoneor, preclinical, precursor, premating, premature, presence, prevalence, primate, PRINCIAPL, printed, printing, privacyprotectiontotheindividualthan, Prize, pro, procedure, proceeding, processinconnectionwithobtainingmarketingapprovalsofanyproductsthatwedevelop, processofobtainingregulatoryclearancesorapprovalstomarketamedicaldevicecanbecostlyandtime, productanditscomponentsare, Productcandidateclaimsorthatthe, Productcandidatesachievesmarketacceptancewilldepend, productcandidatesinthe, productcontainingan, productforoneor, productin, PRODUCTmanufacturedatourownfacilityiscomparableto, productsandproductsapprovedforcommercialdistribution, productsareeligiblefor, productsbasedonourtechnologiesin, productscouldadverselyimpacthowmuch, productscouldrequireustoconductclinicaltrialsandtoreviseourfilingswiththeFDAandotherregulatory, productsmayprovidegreatertherapeutic, productsofothercompanieshavebeenthesubjectofenforcementaction, Productswillreviewthe, profile, Programme, programor, progression, Proleukin, promising, propertylicensedfromthirdpartiesorotherwiseobtainedfromthirdpartieswithwhomwehaveenteredinto, prophylactic, proportional, prosecutionormaynotresultinpatentsbeingissued, ProstaDerm, prostate, protectionof, protein, protocol, proton, proven, Provenge, published, pulsed, purification, put, QbD, qualitysystemandtechnicalreviewandtestingof, quoted, Radiological, randomized, rapidly, rationale, reasonsinacompleteresponselettertothesponsor, receivepriorityreviewiftheyprovidesignificantimprovementin, receivership, recombinant, Recombio, reconstitute, reconstitution, reductioninthescopeofoneor, referral, refusaltoapprovependingapplicationsformarketingapprovalofnewproductsorsupplementsto, refusaltoapprovependingapplicationsformarketingapprovalorclearanceofnewproductsor, refused, Reg, regimen, regular, regulatoryaction, regulatoryapprovalswillmostlikelydelaycommercialization, regulatorystrategieswithrespecttowhichregulatorypathwaywillbenecessarytoobtainclearanceorapprovalof, reinstate, relatingto, relinquishing, remission, rental, repeated, repertoire, replicate, replicating, replication, reporttherecallswithinrequired, reproducibility, reproducible, reproductive, requestsforadditionalinformationorclarificationregardinginformation, requireadditionalresourcesandcouldbecostly, requirecertaininformationaboutclinicaltrialsfor, requiredapprovalsorcommercialization, requiredbythe, requiredto, requiredtoobtain, requirethata, researchanddevelopmentprogramsandhavesubstantiallygreaterfinancialresourcesthanwedo, resembling, reservoir, respecttowhichregulatorypathwaywillbenecessarytoobtainclearanceorapprovaloftheDermaPrepcomponent, responding, restore, restored, resultinincreasedscrutinybygovernmentenforcementauthoritiessuchastheOfficeofInspector, resultinlimitationson, resultsofcertain, resurgent, revealed, reviewandapprovalof, reviewedby, reviewof, reviewofcombinationproductsisoftenmorecomplexandmoretimeconsumingthanthereviewofproduct, RGT, ribavirin, riskdeviceeligiblefor, RNA, Rodriguez, routine, RTF, Russia, safeharbormay, safer, safest, safetyandefficacyof, salvage, sample, satisfactoryresolutionofany, save, saving, SBA, SBIC, scalable, scarification, screening, secondary, secretsorotherproprietaryinformationof, segregation, Senior, sequence, sequencing, Serial, seriesofcomplexregulationsand, setany, sex, sexual, shape, shelf, shorter, shortest, Significantuncertaintyexistsasto, SILCAAT, silico, Silverman, Simian, similarex, similarly, simplification, simultaneously, situation, SIV, sizeable, skin, slowly, smallpox, sneezing, Somogyi, SOP, South, sparing, specificindicationthanour, spent, spherical, sponge, sponsorofadrugreceiving, stable, Standardsestablishesthepresumption, statistical, statistically, statuteprohibitsknowingly, stepsinthedevelopmentandmanufactureof, stimulate, Stockvest, stored, strategic, stratum, strong, studiesandformulation, studiesundertheFDA, submissiontothe, submitarequestforassignmentto, substancethatcomplieswithbothFDArequirementsandstateandfederalprivacyandhumansubjectprotection, substantialliabilitiesorberequiredtolimitcommercialization, substantiallyallofourproductrevenuesfor, substitutecomponentorproductcandidateissufficientlysimilartothepreviouslyproducedmaterial, subtype, successfullycommercializediftheseclinicaltrialsarenotsuccessful, suchlitigation, Suchstatehealthinformationconfidentiality, sued, sufficientproductliabilityinsuranceatacceptablecostagainstclaimscouldpreventorinhibitthecommercialization, suing, superior, suppliershaveenoughexperiencemakingtheseProductsor, supportour, suppressed, suppression, suppressive, surethattheFDAwillnotselecttohaveour, surface, survival, susceptible, suspension, swine, symptomatic, syndrome, synthetic, systematically, Szeged, tailored, takeover, Tapemark, target, targeted, targetedin, targeting, technicalknowledge, temporarily, terminology, testingmaynotadequatelydemonstratethe, Thailand, thanPhase, thatanyofourproductcandidateswillreceiveacceleratedapproval, thataresuperiorto, thatex, thatin, thatisreasonablylikelytopredict, thatlegislationthatreducesreimbursementforour, thatpointand, thatthenewproductissubstantiallyequivalenttoother, thattherisksto, thatthesubmissionwillbeacceptedforfilingorthattheFDAmaynotissueaRefuse, thattheyareeffectivefor, TheANTIGENeering, theapplication, theapprovabilityofthedevice, theareaofproductionandqualitycontrolto, thebasisofadequate, thebiologicsandmedicaldeviceindustryhavesufferedsignificantsetbacksin, Thebiopharmaceuticalindustryischaracterizedbycompetingintellectualpropertyanda, theCDRHeitherinconsultationwithCBERaspartof, theclinicaltrialmanufactureof, thecompletionof, thecomponentsor, thedegree, TheDermaViristheonlyProductwearecurrentlytestinginclinicaltrialsanditmayneverbe, theDermaVirorourotherproductcandidatescouldbecurtailedorsignificantly, thedeviceor, TheeMINERsoftware, theeventof, theeventthatwebecomesubjecttoapatentinfringementorother, theeventwe, theex, thefacilitiesatwhichthefinished, thefailuretoadheretoourclinicalprotocolsorregulatoryrequirementsorfor, thefailuretocomplywith, thefda, TheFDAandEMAmayrequireadditionaltestingbeyondwhatwe, theFDAandotherapplicable, theFDAandotherregulatoryauthoritiesconsidersafeforhumansand, theFDAdoesnotensure, theFDAhassubstantialdiscretionindecidingwhethertoacceptdatafromour, theFDAmay, theFDAmayimposerestrictionsontheapprovedindicationsordistributionoftheproduct, TheFDAmayor, theFDAmayultimatelydetermine, theFDAmightapprove, theFDAmustdeterminewhichcenterorcenterswithinthe, theFDAortheEuropean, theFDApermitscommercialdistributionofanewmedicaldeviceonlyafterthedevicehasreceivedclearanceunder, theFDAto, theFDAtodeterminecompliancewithapplicable, theFDAwillreviewtheproduct, theFDAwilltypicallyrequestadditionalinformationorclarificationoftheinformationalreadyprovided, TheFederalFalseClaimsActprohibitspersonsfromknowinglyfilingorcausingtobefiledafalseclaim, thefollowing, theFood, Theforeignregulatory, Theformation, thefulleffecton, thehealthcareindustry, thein, theINDsponsorandtheFDAmustresolveanyoutstandingFDAconcernsorquestionsbeforeclinicaltrialscan, theintellectualpropertythatwelicensefromsuchthirdpartiesorotherwisehavetherighttousethrough, theIRBcouldsuspendaclinicaltrialatanytimefor, theircontrol, theministryof, thepathtoregulatoryapprovalwouldbedifferentandcouldbe, thepayor, thepreparationofabiologicor, theproduct, theproductand, theQualitySystem, therapeutic, therapy, Therecanbenoassurance, therehavebeenanumber, thereisnoprecedentfor, TheresultsofourclinicaltrialsmaynotsupportourProductcandidateclaimsormayresultinthe, Theriskofourbeingfoundinviolationofthese, therisksassociatedwith, thesafetyoreffectivenessof, Thesecollaboratorsmayalsohaverelationshipswithother, theselawsarebroadandtheirprovisionsareopentoavarietyof, Theseorganizationsalsocompete, Thesephasesgenerallyincludethefollowing, theseproductsmay, Thesesafeharborssetforth, Thesestepsmay, thesourceforour, thesponsorfailstoconducttherequired, ThestepsforobtainingFDAapprovalofaBLAto, thesuccessfulcommercialization, thetreatment, thetreatmentofa, thetypeanddegreeofdifferencesbetweenmanufacturingprocessesorcomponentsubstitutionsforaProduct, theUnited, Theymaynotassignasgreataprioritytoourprogramsorpursuethemasdiligentlyaswe, thirdpartiesdonotsuccessfullycarryouttheircontractualdutiesorregulatoryobligationsor, thirdpartiesfromwhomwe, thirdpartiesmaydeterminenottoprotecttheintellectualpropertyrightsthatwelicensefromthemandwe, thirdpartiestoconductourpre, thirdpartiestoprovidetheAPIand, thirdpartieswithwhomwe, thirteen, thisarea, Thiscouldmateriallyandadverselyimpact, Thisdemonstrationrequiressignificantlaboratoryresearchandanimal, thisstatuteisafelonyandmayresultinfinesorimprisonment, thoserelatingto, threatened, threateningconditionsandthatdemonstratethepotentialtoaddressanunmetmedicalneedforsuchacondition, threetimesthe, Thymon, tissue, toabandonaproductcandidateandmaydelaydevelopmentof, toanappropriate, toanyof, tobeabletoobtain, tocompetewillbeharmed, tocontainhealth, tocorrectdeviationsfromregulatory, todiscontinuesellingour, todocumentaclinicalbenefitinthecaseofbiologicsapproved, toenrollpatientsinourclinical, toex, toinformationneededtosupportanychangesfromthedevicecovered, Toke, tolerability, tolerate, tolerated, tomanufacturethefinishedProductourselvesinsufficient, toobtainmarketingclearanceandapprovalfromtwodifferent, top, totakeadditional, totheextentthatour, totheperformancegoalofreviewingproductsawardedpriorityreviewwithinsix, tothesatisfactionof, toxicity, trademark, tradesecret, trafficking, transcription, transdermal, transient, transiently, travel, trial, trialprocessmayfailtodemonstratethatourproductcandidatesaresafeforhumansor, trialsasthepatientpopulationmaychoose, trialsmay, trialsthanthose, trialsubjectsareadequately, trialsubjectsoutweighthe, trialswillexperienceadversesideeffectsthatarenotcurrentlypartof, Truvada, tumor, twenty, twomeansofpotentially, twoormoreregulated, type, typicallybecauseitisusedbyagreaternumberandmorediverse, UANBLE, ultrafast, unabletodefendsuchintellectualpropertyrightsonourownorwe, unanticipated, Unaudited, Unauthorizedpartiesmayalsoattempttocopyorreverse, understood, undetectable, unfavorable, uninfected, UNKNOWN, unknownproblemswithany, unknownproblemswithanyapprovedcommercial, unlesswereceiveapprovalfromthe, unmet, unregistered, uptake, USA, USSN, validly, valuable, vastly, VaxOnco, vector, Vical, VicePresidentofResearch, Vienna, violated, violationof, viral, Virax, viremia, virology, visit, visualization, visualize, vitro, vivo, VLP, volatility, VRC, VSSP, warning, WealsowillberequiredtosubmittotheNIHthe, Weandourcontractmanufacturersaresubjecttosignificantregulationwithrespecttomanufacturing, Weare, Wearecurrentlydevelopingourregulatorystrategieswithrespecttowhichregulatorypathwaywillbe, Weareintheprocessofdeveloping, Webelievethatourproductsaredefinedascombinationproductsconsistingof, Wecannotbecertainthatwewillsuccessfullydefendagainstallegationsofinfringementofthirdparty, wecurrentlyanticipatebeforetheywillconsiderourproductsfor, Wecurrentlycarryclinicaltrialinsurance, Wecurrentlyrelyonalimitednumberofvendorstosupplyrawmaterialsforourproduct, Wecurrentlyrelyonthirdpartiestomanufactureandsupplyuswiththerawmaterialsthat, Wedependin, week, Weestimatethatclinicaltrialsofourlead, Wehaveonlylimitedexperienceinpreparingandfilingtheapplicationsnecessarytogainmarketing, Wemayalsoberequiredto, Wemaybesubjecttodamagesresultingfromclaimsthatouremployeesorwehavewrongfullyusedor, Wemaybeunableto, Wemaybeunabletoprotecttheintellectualpropertyrightsofthethirdpartiesfromwhomwelicense, wemaybeunabletosellour, Wemaydirectlyor, Wemayincursubstantialliabilitiesandberequiredtolimitcommercializationofourproductsin, Wemaynotbeabletoobtaininsurancepoliciesontermsaffordabletousthatwouldadequatelyinsureour, Wemusthireandtrainasignificantnumberofemployeesand, Weplanto, wereliedonAlthea, werenot, West, Western, Wewillberequiredtodemonstrateproduct, WewillneedtodemonstratethattheDermaVir, WGX, whichcouldnegatively, whicheverprovidesgreaterprotectionof, whichmust, whichweareunaware, whichwouldhaveamaterialadverseeffect, whichwouldimpactourdevelopmentplan, willtypicallyissueanapprovalletter, win, Wistar, withapplicableregulationsorifaviolationofourproductspecificationsorapplicableregulationoccursindependent, withcGMP, withGCPto, withrelativelyshortnotice, withrespectto, withthechosencentertaking, WO, women, workflow, worldwide, wouldbeharmed, wouldconstituteamajorchangeinintendeduse, wouldharmourreputationandcauseourproductsalesand, Xenotropic, XMRV, XVIII, Ybl, yield, yielded, York, Zsolt, zur

Removed: accommodate, AccRoll, accurately, add, adequacy, ADP, agreeable, aimed, air, annotation, annul, assist, attain, attempt, attendant, bank, base, BDO, began, beneficiary, beta, bookkeeping, brought, budgeted, building, call, cautioned, cease, challenge, challenging, cholesterol, choose, close, Codification, collaborative, Colleague, column, commercialisation, compete, competition, concentrated, conclude, concur, conducting, considerable, contractual, controller, converging, counsel, create, Creek, defending, demonstrator, detect, detection, deteriorate, DHL, diligently, direction, discernable, discharge, discretion, disposition, disqualify, diversified, Division, documented, eared, Economist, economy, edge, efficiently, employer, encounter, encountered, ending, Energy, engineering, enhancement, enjoy, exceed, exclusively, executing, expert, expiration, exploitation, favor, feasibility, fighting, flexibility, footprint, foresee, Forte, Gibsonville, hearing, heating, hourly, identification, impacted, implementation, increasing, influencing, infrastructure, intelligent, intense, intent, intentionally, interpret, Ireland, ISO, Istvan, join, joining, judge, jurisdiction, Kalman, lacking, language, lay, leadership, leased, Lira, marketplace, mediate, merit, mislead, MKVK, monetary, motion, mutually, narrower, NC, occupational, offer, open, operated, operator, opposed, OTC, pace, partially, participate, paying, performing, Pertain, posting, preclude, premier, prosecuting, qualify, readily, receipt, recruit, Regional, regulating, relevance, render, requisite, researched, reseller, reviewing, riskiest, river, SAB, salaried, salary, Salca, salesperson, satisfied, sector, secure, selectively, sense, sensitive, server, simple, Sligo, sporadic, stabilization, studying, submitted, superseded, telephone, tenure, TMF, Tr, trained, training, transition, trend, TUV, ULTI, ultimate, unqualified, unsafe, user, Vagi, vary, venture, verdict, verification, water, wide, wise, withdraw, workforce, yearlong

	/s/ Viktor Rozsnyay
	Viktor Rozsnyay
	Title: President & Chief Executive Officer

Power of The Dream Ventures (PWRV) Inactive 10-K2012 FY Annual report

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