LaJollaPharmaceutical(LJPC):PriceTarget$4.

00
Part1inaMultipartSeriesbyArtDoyle

LJPC-501: The Case of the Worldwide Voyage to Find the

Bogus Endpoints

Wewrite
letterstothe


FDAonYOUR
behalf!

Butfirstletsplay

Fellowadventurers!Letsplayagametogetreadyforourtrip!TANGOislike
BINGO.Lookatthese8reallifeTRUEFACTSabove.Ifyoualreadyknow
everything,youprobablydontneedtogowithusonthisjourney.Butifyoucan
connectalinebetweenanyTHREEfactsyouDIDNOTALREADYKNOW(including
theFREESQUARE),thenthisreportisforyou!

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 WEBELIEVETHECOMPANYISMISLEADINGSHAREHOLDERS
WedonotbelievetheCompanysstatementsabouttheFDAsigningoffonthistrialasisnor
dowebelievethisdataissufficientforapproval.WeexpecttheFDAtorejectthistrialand
forcetheCompanytoconductanewtrial.

LaJollaPharmaceutical(LJPC):PriceTarget$4.00
Part1inMultipartSeriesbyArtDoyle
LJPC501:TheCaseoftheWorldwideVoyagetoFindtheBogusEndpoints
DearFellowAdventurer,

Thank you for joining us on this journey that the management of La Jolla Pharmaceutical (LJPC) have
decidedtotakeuson.Wehavedecidedtodocumentourlittleadventurehereandturnitintoafun
multipartseries.SomeofyoumaybenewtothisadventureintheformofnewshareholderstoLaJolla
Pharmaceutical(whatwiththeirbignewofferingandall).Basedonsomeofthequestionsweheard(and
didnthear)duringtheofferingprocesssomeofthisisreallygoingtobeatrueadventureforyouso
buckleupandletshavesomefun!

Wherewillthisjourneytakeus?

Thefirstpartofthejourneyistodiscover(sinceWallStreetfailedyou)howacompanyseeminglymade
upanendpointtofitafailedtrial.YesthespecificprimaryendpointwasmadepublicinDecember2016
afterthetrialwasalreadyover.HereisapreviewofthischangeintheirprotocolfromDecember2016:

ThesecondlegofthejourneywillshowyouthatLaJollaPharmaceuticalappearstobekeepingsome
secretsfromitsinvestors.Specifically,ithasbeenveryselectiveinwhatitdisclosesaboutwhatiswithout
questionthemostimportantclinicaltrialinthehistoryoftheCompany.(SeeNetRoadshowpartofSection
2).Andwhattheyappeartobehidingaboutthetrialwebelievesaysalotaboutthedrugitselfandthe
market(orlackthereof)forthedrug.

Whatwillwefind?

Thecompanychangedtheendpointtofitthedata,unfortunatelythedatathatremainsisdogshit.The
phrasewewantyoutorememberisBLOCKEDRANDOMIZATION.(InSection1wehaveachartthatmakes
thisreallyeasytounderstand).Thephysicianswhohavealreadyseenthefulldatasetbutarenotaffiliated
withthecompany(seeBiocenturynoteattheendofthereport)appeartoagreewithusonthetrial
designandthedata.Wedonotbelievethathospitalswillbuythisproductandmostimportantlywe


believetheFDAisgoingtoseerightthroughthisruse.WANTTOBETUS?WEHAVEWRITTENALETTER
TOTHEFDAexplainingthelastminuterunaround,themisleadingcommentarybymanagementandthe
overalllackofclarityaroundthisprogram.WEARE100%suretheFDAwontlikethisdataandATBEST
willmakeLaJollaPharmaceuticaldoanotherclinicaltrial.GOAHEAD,FOIAourletter.Butbeforethat
rememberthatLJPCfailedtoprovideanyotherdatatoinvestorsthanvictoryonalastminutetailor
madeprimaryendpointandafailonasocalledexploratoryendpoint(thereisnootherwaytodescribe
themortalitydatathanaFAIL).Whentheyfinallypullbackthecurtainontherestofthedatasetthey
havebeenhidingfromyouitwillbeyou,theinvestor,whowillbeleftholdingthebag.Asfortheone
investorbackingLaJollaPharmaceutical?Googlethem.Theonegoodluckytrade,themodelingagency,
theSECchargesofmarketmanipulation.Goforit.Weknowwhowearecompetingagainst,andwewill
win.

TheAdventurersREWARDisanamazingopportunityforyou
longstohaveALLTHEINFORMATION.Webelieveabetter
informedinvestorwillSELLTHEIRSTOCK,eliminatingfutures
losses.Forothers,achancetoprofitwhenthiscompanyis
exposedinitsPhaseIIIruseandtradeslower.

Sonowtobegin:LetsjustcallthesubtitleforthisPart1TheDueDiligencethatYouShouldHaveDone
ButDidnt.ThisisntaChooseYourOwnAdventure,sopleasedontjustskiptotheendwherewewrite
totheFDAwithourfindingsonbehalfofallLaJollaPharmaceuticalshareholders.

HereishowwehavedividedthisfirstreportonLaJollaPharmaceutical:

Section1:TheMysterious,BogusPrimaryEndpoint

DidyouknowthatthesocalledprimaryendpointthatLJPCmanagementclaimsthattheyagreedtowith
the FDA as part of a SPA doesnt appear in published record in ANY format (press release, company
presentation, clinical paper, SEC document, clinicaltrials.gov website, etc.) until December 22, 2016?
ThatsAFTERTHESTUDYWASCOMPLETED.Letthatsinkinforasecond.Oh,andwearegoingtoshow
youhowtheirprimaryendpointmagicallyfitsthedesignoftheirclinicaltrial.Youwontbeabletohold
ontoyouradventurerhat!

Section2:TheMagicalWorldJourneytoFindPatients

Ihatetobetheonetobreakthistoyou,buttheLJPC501trialwasntactuallyapredominantlyUStrialat
all.75ofthe115sitesopenedwereoutsideoftheUS,withnearlyallofthosebeingopenedAFTERthe
USsiteswereopened.Europealonewasexpectedtoenrollapproximately200ofthepatientsonthe
studythatsalmosttwothirds.Doyouknowwhoelseisgoingtobereallysurprisedbythisinformation?
TheFDA.Itsreallypeculiar,becausethenumberofUSpatientsthatLaJollaPharmaceuticalmanagement
claimssufferfromtheconditionitisattemptingtotreatkeepsincreasingineverycorporatepresentation.
Whatstartedoutas75,000to100,000patientsin2014isnowupto196,000peryearinthemostrecent
corporatepresentation.

Section3:HuntingforSuperRespondersACEintheHole

The pilot study upon which the LJPC501 study was based on found that there appeared to be super
responders.ThesepeoplereactveryquicklytoangiotensinIIandverylowdosesareneeded.Infact,
thesepeoplebecomehypertensive.Thetheoryisthatthesepeoplearelikelyonaverycommonclassof
hypertensiveagentscalledACEinhibitors.Inmanyways,LJPC501issortoflikeanACEinhibitorantidote.
Soundscool,exceptthatsnotanythinganyonereallyneeds.Soifyouweretryingtogetsuchathing
approvedandyourefusedtocallitanACEinhibitorantidotewhatbetterwaythantorunahypotension
studyandstackthedeckinyourfavorbyfocusingoncountriesthathadVERYhighutilizationofACE
inhibitors.Oh,youmeancountrieslikeCanada,AustraliaandtheUK?Exactly.

Section4:TrialbyFireTheProtocolofDoom

Inadditiontotheprimaryendpointwhichappearstohavebeencreatedoncethetrialwasalreadyover,
theprotocolforthetrialitselfwillalarm(unaffiliated)cliniciansandtheFDAalike.Raisingbloodpressure
athourthreebut providingnoother benefit tothepatient(as anyclinician willtellyou) isabsolutely
worthless.Andonewayyoucanguaranteethatyouwontprovideanybenefitisifyourprotocolforces
thepatienttostayonthesamedoseofvasopressorstheywerealreadyonwhichisexactlywhatthe
protocoldoes.TherearereasonswhyLaJollaPharmaceuticaldoesntwanttoshowyouanymoredata:
itisourbeliefthatalloftheotherendpointsfailedjustlikethemortalityendpoint.Andso,intheabsence
ofANYTHINGelsethatshowsthisdrugwashelpful,theCompanychoosestohideitandmakeexcuses.
OH,andbytheway:LaJollaDIDNTDOASEPTICSHOCKSTUDYSOTHEYSHOULDSTOPCOMPARING
THEIRSTUDIESTOTHOSETHATARE.

WEEXPECTLJPCSHARESTOTRADEATBELOWCASH(<$6)DUE
TOTHEADDITIONALTRIALTHEYWILLNEEDTORUNTHATIS
ACTUALLYBASEDINTHEUNITEDSTATESWITHREALENDPOINTS

Section1:TheMysterious,BogusPrimaryEndpoint

Thereisalottocover,sowearegoingtostartwithsomethingwethinkisvitallyimportantandthentell
youabunchofotherstuffaboutLaJollaPharmaceutical(LJPCortheCompany)toroundouttherest
ofthestory.First,itsimportanttosaythateverythinghereisanOPINION.Second,itsimportanttosay
that everything here has been obtained through publicly available information. So lets start with
somethingeveryonewhofollowsbiotechnologystocksmightknow:

OnFebruary27,2017,LJPCannouncedPositiveToplineResultsfromitsATHOS3Phase3StudyofLJPC
501.

Thekeytothispositivetoplineresults(buriedwaybackonpage13)wastheirassertionthattheanalysis
of primary efficacy endpoint was highly statistically significant. Specifically, they claim that the
percentageofpatientsachievingprespecifiedtargetbloodpressureresponsewastheprimaryendpoint,
andthat23%oftheplacebopatientsachieveditcomparedto70%oftheLJPB501patients.

Hereiswherethingsgetfunnyrightoffthebat:

1) FromtheveryfirsttimeLJPCfirstmentionedthisprogramupuntilDecember22,2016(justalittle
over 3 months ago), the primary endpoint has ALWAYS BEEN INCREASED MEAN ARTERIAL
PRESSURE(MAP).Itisreferredtothiswayineverysinglepresentation,SECdocumentandevery
FDArelatedprotocoldocument.Furthermore,theCompanyspokefrequentlyaboutaSpecial
ProtocolAssessmentithadwiththeFDAallthewaybackinFebruary2015.
2) SowefinditverypeculiarthatonDecember22,2016andforthefirsttimeonDecember22,2016
doweseeareferencetothefollowingchangeintheprotocolasbeingthenewprimaryendpoint
forthetrial:AnincreasedMAP,definedasachievementofaDay1MAPat3hoursfollowingthe
initiation of study drug, of >75 mmHg OR a 10 mmHg increase in baseline MAP. And lo and
behold,thatsexactlywhatweseeasthefootnoteonpage13inlightgraytextoftheirrecent
results.
3) Herearesomefactsaboutthisnewendpoint:
a. Itisntclinicallyrelevant(atleast,notonitsownthisisvitallyimportantlater)
b. Itdoesntappearinanytextbooks,algorithmsorjournalarticles
c. These words >75 mmHG or a 10mmHg increase in baseline MAP do not appear in
publishedforminanywaypriortoappearingonthatprotocol.Itmaterializedoutof
thinair.
4) Sohowdoesonecomeaboutchangingtheirendpointattheendofthetrialwhentheyare
alreadydone?Thatsafantasticquestion.IguesstheywouldarguetheydidntCHANGEIT,
moreliketheymassageditsome.But100%thiswasnotaprespecifiedendpoint,norisita
widelyacceptedendpointbycliniciansnorisitonetheFDAhaspreviouslysignedoffon.
5) Howdidtheydoitandwhy?HereisONETHEORY:
a. IfyoureadthroughtherecentlypublishedprotocolintheMarch2017CriticalCareand
Resuscitationthatwasauthoredbytwomembersofthecompanysmanagementteam,
oneguywhodiedtwoyearsagoandacoupleguyswehaveneverheardof,theyreveal
thattheydidatechniquecalledblockedrandomizaton.Specifically,theyrandomized
patients1:1intoplacebo:LJPC501baseduponwhethertheywereinoneoftwogroups:
screeningMAP<65mmHgand65mmHg.Soletsbreakthisdownlogistically.Patient
comesinandtheythinkhe/shemaybeacandidateforthetrial.Theydothescreening

processandbringthemthroughthebeginningpartoftheprotocolwheretheyseeifthey
cangetthemuptoabaselineMAPthatissuitable.Ifeverythingchecksout,theycall
central(thinkmissioncontrol)withthepatientsbaselineMAPandtheyrandomizethe
patientintoplaceboordrug.Centralsjob,andthegoalofblockedrandomization,isto
balanceoutthestudysothatyouendupwithequalnumbersoflowandhighMAPpeople
ineachgroup(therewasalsoanAPACHEscorecriteriaaswell).Visuallyspeaking,thisis
howitshouldlook:

Allthesquaresareequalsizes.Thesickerpatients(wewouldassume)withthelower
MAPsatbaselinewouldbeontheleftandtheoneswiththehigherbaselineMAPs
wouldbeontheright.Butalltheboxeswouldbethesamesizebecausemissioncontrol
wouldmakesurethatwhenthestudywascompletedeverythingwasbalanced.Funny
thatphrasewhenthestudywasCOMPLETEDLikeDecember22,2016?BecauseifI
wantedtocreateabrandnewendpointthatwoulddescribethisrandomassortmentof
boxesabove,itwouldbeEXACTLYLIKEthechangetheymadetotheprotocolafterthe
studywasdone.HereishowitwouldworkTHEORECTICALLY:

NowdoyouseewheretheORcomesfrom?WhatbetterwaytocapturesmallerdifferenceinMAPin
bothpopulationgroups(groupsyoucreatedonpurposewithyourblockrandomization).Bymakingplus
10oneofthecriteriayouwillcapturethelowerend(peoplethatstartedlowthatadded10).Bymaking
the>75cutoffyouwillcapturepeoplethatwerealreadyprettyhightobeginwithkeepinmindthatthe
inclusioncriteriaforthisstudyisUPTO70mmHG.Soalltheywouldneedtodotodeclarevictoryisto
getapatientfrom70to75inthehighgroup.Andthatisasuccessfuldrug?

Thisisntarealendpoint.Itscompletelymadeup.Webelieveitwasmadeupafterthestudywasover.
Itwasmadeuptofitthewaytherandomizationwasdone.TheCompanyhas,onmanyoccasions,implied
thatithasoperatedthistrialunderaSPAwiththeFDAandthattheFDAhassignedoffontheendpoint.
WeDObelievetheysignedoffonMAP.WeDONOTbelievetheysignedoffonthisEITHER/ORbullshit
andneithershouldyou.Howisthisendpointclinicallyrelevantonitsown?!Howisitnotspecifically
tailoredtohowtheydesignedthestudy.Hereareacoupleofevenmoreadvancedtheoriestothink
ponder:
Askingforafriend:didthecompanyseetheblindeddatabeforecreatingthisendpointafter
thetrialwasover?ItisfrowneduponbytheFDAbutisntacardinalsin.
Askingforafriend:whydidthecompanyexpandthetrialattheveryendfrom315to345
patients?Isitbecausetheysawblindeddataandneededtobumpthingsupalittle?Its
highlyunusualtojustincreaseenrollmentattheendofatrial(asopposedtoachangemade
earlyoninthetrial).Whatwentintotheirdecisiontoexpandthetrialatthelastminute?

KeepinmindthisisLaJollaPharmaceuticalLEADPROGRAM.Yet,theirSPECIFICPRIMARYENDPOINT
WASNOTPUBLICLYDISCLOSEDUNTILAFTERTHETRIALWASOVER.Doesthatmakeanysensetoyou!?

Butwait,wouldnttheCompanysmaininvestorknowwhattheprimaryendpointwas?OnAugust4,
2014,Jefferieswrotearesearchreport(BUY,Pricetarget$25,natch)aboutLaJollaPharmaceutical.They
helpfullynotethatInJuly2014,JefferiesactedasthesolebookrunnerinafollowonofferingofLJPC
commonshares.TheanalystThomasWeihadthistosayabouttheprimaryendpoint:

Well,yousaywhatdoesThomasWeiknow?Maybehedoesntknowanendpointfromanarmpit.Well,
hebetterknowLaJollasendpointsprettywellbecauseThomasWeiisnowamanagingdirectoratnone
otherthanTangCapital.WouldTanghavehiredhimifhewasntsmartenoughtotranscribethesimple
either/orinformationthatwasprovidedtohimbytheCompany?Ofcoursebecauseitwasntprovided
tohimortheFDA.

WEBELIEVELAJOLLAMADEUPITSENDPOINTTOFITITSDATA
THEFDAANDCLINICIANSWILLSEERIGHTTHROUGHTHISCHARADE,ESPECIALLYSINCEIT
APPEARSALLTHEIROTHERENDPOINTSWEREAFAILURE

Section2:TheMagicalWorldJourneytoFindPatients

Wehaveandwilltalkalotonthisjourneyaboutconcealmentoffactssomethingthatwebelievethat
LaJollamanagementdoesconstantly.OntherecentNetRoadshowfortheLaJollafollowonoffering,
someoneaskedCEOGeorgeTidmarshifthedatafromtherecentLJPC501trialwouldsupportafilingin
Europe.ThiswouldhavebeenaGREATtimetotellhimtheBIGSECRETtheoneweareabouttoshare
withyou.No,therewouldbenosecretrevealingtodayforLaJollaPharmaceutical.Instead,Tidmarsh
saidthatthecompanybelievedithadthedatatosupportaEuropeanfilingbecausetheyhadsome
centersthereduringthetrial.

some?George,George,George.

Well,wetoldyouthiswasanadventure,soheregoes.

LJPC501 was supposed to be conducted as a US based trial in 3035 centers (see all their early
presentations back in 2015. They didnt even bother to change it to a global study until the great
protocolchangeofDecember22,2016.Bythetimethestudywascompleted,therewereover110study

sitesinitiatedaccordingtothedocumentstheyhavesubmittedbothtotheFDAandtoajournalrecently.
Strangely,theyfrequentlysay(suchasintheirrecenttrialresults)thatthestudywasonlyconductedin
74centers.Sowhatgives?Westeppedthrougheachandeveryeditthatwasmadetotheirprotocoland
cameupwithagraphtodepictwhatwasreportedandtheresultsarefranklyridiculous(emphasisand
annotationsours):

LooksliketheystartedtomakegoodontheirdesiretodoaUStrialandthewheelscameoffreallyquick.
Bythebeginningof2016theywereinCanada,thenAustralia,andthenEurope.Mindyou,theseareTINY
markets for any pharmaceutical in comparison, let alone the US. The US has a very large and well
organizedcriticalcaresystemandinitiallytheyhadsomesuccessinsigningupsomecenters.

Letstakethisonestepfurther.WhatwerethenonUSsitessayingaboutthistrial?Maybetheywere
justthinkingtheywerePlanBabackupifyouwill?NONONO!Lookatwhattheofficialclinicalregister
inFINLANDexpectedtheirenrollmentinthetrialwasgoingtobe:

NowhowaboutthegreatcountryofGERMANY(MissUniverseannouncervoice):

Yes,youarereadingthatright.FIFTYinFinlandwheretheywerentevenauthorizedtostartthetrial
untilFebruaryof2016(trialendedin2016).THIRTYinGermanywheretheywerentevenauthorizedto
startthetrialuntilAUGUSTOF2016.Buthereisthekicker:200patientsexpectedtobeincludedfrom
the EEA (that is Europe) alone. That doesnt include the Canadian sites. That doesnt include the
SHITLOADofAustralian/NewZealandsites.ThesearejusttheonesfromEurope.AtNOPOINThasLa
JollaPharmaceuticaleveraddressedrecruitmentissueswithintheUnitedStates.Norhavetheyexpressed
theirpreferenceforrecruitingpatientsoutsidetheUnitedStates.SomesitesinEuropetheysay.How
aboutMostofourpatientscamefromEurope,actuallyIthinktheFDAisgoingtobethetougherhillto
climb.GreatquestionandthanksforyourinterestinLaJollaPharmaceutical.

Beyond the issue of just concealing these issues from shareholders is a much more important one: I
THOUGHT YOU TOLD US THIS WAS A HUUUUUGE MARKET?!? In each shareholder presentation, the
numberofpotentialcasesthatcoulduseLJPC501keptgoingupandup.In2014,youtoldus75,000to
100,000cases/yearintheUSandthatyouwerefilingfororphandrugdesignation.(Sidenote:IsLaJolla
PharmaceuticalseriouslytheonlycompanyintheworldtonotgetODDafterapplyingforit?)Inyour
mostrecentpresentationwithyourtoplineresults,youtoldusthattherewere196,000casesperyear
intheUS(convenienthowthatisbelowthe200,000caseorphandrugthresholdkeepthehopealive!).

Wearentthatgoodatmathbutthatissomethinglike500casesPERDAYintheUnitedStatesalone.The
trialonlyneeded315!!!Thisisabilliondollaropportunityyouarepitchinguson.SOWHYCANTYOU
RECRUITPATIENTSTOTHISSTUDY?WHEREARETHESEPATIENTS?!?Youtellusonthecallsthatyouare
goingtohaveyourownsalesforceintheUSbecauseyoualreadyknowallthecenterswherethepatients
are.DOYOU!?Wasitthesame40plusorwhatevercentersthatweresounsuccessfulindeliveringa
trialtoyou?

AndwehavelookedthroughyourcentersandyoudidNOTpickthetoptiercentersthattreatshockin
the United States. You already know that, but do your investors? If you work with the University of
MarylandonashocktrialitdamnsurebetterbethelocationonGreeneStreet,son.Peoplecanreada
map.NoneofthisSouthPacaStreetbullshit.Thatisamateurhour,liketherestoftheirattemptataUS
trial.

Ohandonemorething.DoNOTfallforLaJollaPharmaceuticalmanagementtellingyouthatwesaid
itwasaglobaltrial!LookatourprotocolOK,letsdothat!

Oh,youareRIGHT!YoudidsayitwasaGLOBALTRIAL.AFTERITWASOVER,ONDECEMBER22,2016
theSAMEDAYYOUPUBLICLYSTATEDWHATYOURSPECIFICPRIMARYENDPOINTWAS!!!

Finalthoughts:ReactionstothedatasetfrompeoplethatarentbeingpaidbytheCompanyandthe
caseoftheindicationnoonecanfind:

Donttakeourwordforit.Herearesomereactionsyouhaveprobablyseentothissocalleddataand
trial:

ImnotsurewhyonewoulduseangiotensinIItosimplyincreasebloodpressureifitsnotgoingto
leadtoimprovedlongtermoutcomes,Dr.ScottManaker,UniversityofPennsylvania

Cliniciansalreadyhaveanumberofchoices,saidDr.JamesRussell,aUniversityofBritishColumbia
professorofmedicinewhoservedaschairofATHOS3sDSMB.Idontthinkuptakeinthemarket
willbeverybigwithoutfurtherstudies.Inparticular,Ithinkweprobablyneedalargerstudypowered
foraclinicallymeaningfulendpointsuchasorgandysfunction,ormortality,orboth."Weneedto
seeatminimumasignificantincreaseinvitalorganfunction,Russelladded,manyclinicianswould
sayyouneedtoseeasignificantdecreaseinmortality.

Andonelastthing:LJPCcreatedanindication.CatecholamineResistantHypotensiondoesnotexist.
Thereisnospecificreimbursementcodeforit.IfyougoogleitmostofthelinksareabouttheCompany.
Theysayitisthesamethingasshock.Itisnt.Theyaretryingtoconfusepeoplebythinkingtheydida
trialinsepticshock.THEYDIDNT.Onslide8oftheirtoplineresultspresentation(sortofoddsinceit
comeswellbeforetheirownresults)theyputaslideupoftheVASSTstudyandbasicallysaythisstudy
didntreachstatisticalsignificanceforsurvivalat28dayseitherbutitgotapproved.Therearesomany
thingswrongwiththiscomparisonitsembarrassing:

o VASSTisasepticshocktrial.ThatiswhattheSSstandfor.Bythetimethistrialwasdone,
vasopressinhadbeeninusefor95years.Itwasanacademicstudy,notonedoneby
sponsorslookingtomakeabuck.Yes,asponsordidcomealongtogetFDAapproval.
AndtheFDAwasveryreluctanttogiveitFDAapprovalbutifyoureadthroughitthey
basicallysaythishasbeenonthemarketforeversowhocares.Atnopointdotheysay
wethoughtthisonetrialwassupercompelling.
o IfyoulookattheinclusioncriteriaforLJPCstrialyouwillseethatitisntaboutshockat
allbutabouttheirsortofmadeupCRHindication.Theysaythatpatientsmighthave
septic shock, inflammation due to trauma, or severe drug reactions. Huh? Drug
reactions?Thatsnotwhatpeoplehadinmindhere.TrazodoneODs?

Dr.Russellhasseentheentiredatasetanddoesntsound
impressedintheslightest.WHYAREYOU!?
Investors,getreadytoFUNDAWHOLENEWSTUDY

ConcludingourJourney:RefutingtheBullCaseandNextSteps

Wehopeyouhaveenjoyedthisadventureasmuchaswehave.Tofinishthingsup,wewouldliketowalk
throughwhatwebelievetobethekeypillarsofthebullcaseforLaJollaPhamaceuticalsstockandaddress
eachpoint:

THATPVALUETHO!Yes.Inaprimaryendpointthatmaterializedoutofthinair.Onethatwehave
shownappearstonotonlybecraftedtofittheirtrialdesignandblockrandomizationfeature,wealso
suggestthatthecutoffsweresuggestedwiththeblindeddatainhand.
THEYHAVEASPAWITHTHEFDA!WehaveheardalotaboutthisSPA,andwehavealwaysheard
thesamething:theFDAagreesthatwecanuseanincreaseinMAP.WedonotbelievetheFDA
hasanyideaofthefollowingandtheyareNOTGOINGTOLIKEIT:
o Theglobalvoyage(2/3rdsormorepatientsfromoutsidetheUS)
o TheACEinhibitorissue(howmanyresponderswereonACEinhibitors?)
o Wheredidthisspecificprimaryendpointcomefrom?
o Thedrugdemonstrateszeroactualclinicalbenefit.Thethreehourpartytrickisntgoing
tocutit.WebelieveatbesttheFDAmakesthemdoawholenewstudy.

THISISAREALMARKETOPPORTUNITY!Isit?WhycouldnttheyfindanyoneintheUStobeonthe
study?Whycouldnttheygetbuyinfromthemajorityoftoptiercenters?Whydidtheyneedtodo
theglobaljourney?Whydoallcliniciansbasicallyagreethattherearealreadyalotoftoolsinthe
armamentarium?
FINLANDWASNTONEOFTHETOPRECRUITERS!Really?TheRegistersaidtheyweretargeting50
patients.Theyhave5MILLIONPEOPLEintheirENTIRECOUNTRY.Stopit.THATRATIOISABSURD.
Inexcusableandembarrassing.ThiswassupposedtobeaUStrialregulatedbytheFDA.
THEREWERENT115SITES!THECOMPANYSAIDTHEREWEREONLY74.Ohyeah?Thentheyopened
aLOTofsitesthatproducednothing.Becausewedidtheworkandsteppedthrougheachandevery
oneofthesitestheyreportedthattheyopened.Iftheyonlywanttocountthesiteswhowereable
tofindoneoftheseneedleinahaystackpatients,thatistheirbusiness.Buttheregisterhasthem
opening115sites.Dotheworkyourselfhere.Thereareactuallymorethanthatifyouarelookingat
GROSSversusNET(sinceseveralsitesdroppedout).Oh,andwhatisthis,then:

Stay tuned for our next parts in our La Jolla Pharmaceutical adventure
series:
Section3:HuntingforSuperRespondersACEintheHole
Section4:TrialbyFireTheProtocolofDoom
OurCorrespondencewiththeFDA
Breakingdown(andwedomeanDOWN)theirsocalledpipeline