Dirk Haussecker
@RNAiAnalyst
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Biotech enthusiast. There are no alternative truths. Let science and reason lead the way. Defend democracy and freedom of life. Not investment advice
Germany
Joined November 2011
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FDA to Novavax: give me data from 5 clinical trials, incl 2 phase 3s, effectivemess of
#boosters
in current BA.5 wave+ we'll get back to you in couple of months.
FDA to Moderna and Phizer: rodent data? That's so kind of you, but we wanted to authorize you regardless of data.
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$MRNA market+politicians say, let's unleash this vaccine w/ this type of safety profile onto hundreds of millions of people:
mind...boggles
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$NVAX
Korean media: it is a good vaccine, v efficacious + less side effects than mRNA.
Western media: Novavax is a second tier vaccine, only suitable for mRNA hesitant covidiots.
--> Korean media are closer to scientific data, while Western mainstream media parrots politics.
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#covidvaccine
rankings.
Efficacy (against wild-type):
$NVAX 96%
$BNTX $PFE 95%
$MRNA 94%
Safety:
$NVAX...................................(a marathon distance) $BNTX.. $MRNA
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$NVAX on day 2, Nuvoxavid has become number 1 primary covid vaccine in Korea 🇰🇷:
$BNTX $MRNA
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Yesterday, I was fortunate to visit $PRQR headquarters. Here are my impressions.
A bit wordy, but worth your time if this is more than a short-term trade for you (blog):
$WVE
#RNAEditing
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$XBI congrats biotech investors: you are true survivors and will likely have caught the bottom. Large fortunes await many of you.
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$AFMD not really surprised by the muted reaction.
If u are, however, 1 of the few that don't mind having long-term position in portfolio, this could be 1.
The +20% today pales in comparison to the importance of today's data.
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$NVAX I didn't go through all this pain + frustration to sell for $170.
Thank you,
@novavax
.
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8
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$NVAX photos of Nuvaxovid being sent out for delivery; tears of joy to the eyes of
#Novastans
:
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$NVAX I expect US authorization within a week. FDA can't ignore positive panel comments today.
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$NVAX once I have lost all my livelihood (not far from it actually), I will use the time to dig into the unholy Reuters-Phizer-FDA triade.
It's sickening e.g. to see Reuters come out with myocarditis hit piece the minute the Briefing Docs became available. cc:
@Reuters_Health
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$NVAX now has market access to probably 40% of world population (a cool 1 billion added yesterday alone), yet investors obsess abt US approval (3% of world pop).
In general, covid vaccine stocks go up/down based on how covid risk is perceived in the US. 🙄
$BNTX $MRNA
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$NVAX no
#myocarditis
in this 2000+ adolescent trial; No
#myocarditis
imbalance in ~50000 trial participants btw nvx2373 and placebo.
$BNTX $MRNA
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10
90
$NVAX just demonstrated that Novavax boosts best upon Novavax which broadens immune response to cover (future) variants.
No need to take chances on fancy
#bivalents
.
If you just compared
#booster
data of Novavax vs
#Phizer
and $MRNA, Novavax would come out on top.
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20
89
$nvax there is no scientific justification for not approving it in US.
Surprised there is no general biotwitter outrage at apparent corruption in US covidvaccine policy.
I guess, corruption is widely accepted a way of life, so get on with it.
#Phizer
$mrna
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$NVAX (extraordinary) WHO meeting...the real action about to start in 4 minutes:
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$cytk what the heck was this?
CEO just said on call that '3rd parties' have already called that dataset 'pristine'.
He could not be any clearer that M&A talks ongoing.
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$XBI sell-off starting to take my breath away. As if biotech companies had no future value whatsoever.
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$MRNA of course, the most disappointing data (along w/ iffy safety profile) was crammed into end of results section: poor T cell responses, esp CD8.
$BNTX $NVAX $INO
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Shame on
@Shell
for buying discounted Russian oil.
I know where I will NOT fill up over next couple of weeks.
#boycottshell
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$ARWR folks, it's not even a competition at this point.
Based on trig lowering alone, nobody in good conscience will prescribe $IONS olezarsen over $ARWR plozasiran.
Glad we settled the debate over which one is the more potent trig-lowering drug.
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$nvax Europe is suddenly panicking over
#omicron
....lockdowns, harsh quarantine +travel rules. EMA approval tomorrow could not come at a better time for
#nuvaxovid
.
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$NVAX Rheinland Palatinate (pop 4M) opened Nuvaxovid registrations today (1st German state to do so).
By 2pm, 5000 have already registered per the state minister.
Will gather speed IMO.
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Rare moment of pride.
NEW: Germany rejects proposal to waive patent protection for COVID-19 vaccines, says IP is a "source of innovation and must remain so in the future" - DW
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$NVAX 2 phase 3 trials; India, Korea, Japan bridging studies...at least 5 different materials used all yielding consisting safety + immunogenicity...
US FDA questioning how old studies relate to current (improved) manufacturing is purely academic exercise to SLOW-Walk approval.
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$nvax let's face it: nuvaxovid will be the people's vaccine.
EU accelerating delivery request a result of that.
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$NVAX very important after first 2 months of vaccine roll-out:
detailed surveillance in Korea 🇰🇷 and Australia 🇦🇺 support that Nuvaxovid/Covovax substantially better tolerated + safer than mRNAs + adenos.
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11
79
$nvax Yessszzzz!
1st news item of 7pm Deutschlanfunk news ('German BBC')...
Vaccine mandate for medical sector very likely to be delayed to give people chance to get
#Novavax
!
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$NVAX a scandal that the US regulatory agencies won't provide companies like Novavax certainty on openness of EUA pathway.
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My main long positions:
$afmd (NK cell; long-term)
$ions (antisense; long-term)
$sln (RNAi; Lpa story)
$NVAX (pandemic trade)
$BNTX (pandemic trade)
2 shorts
$MRNA (into AdCom/Briefing docs -->poor safety)
$TSLA (increased competition with superior manufacturing)
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$NVAX Disgusted that apart from initial OWS funding award, the world's most promising
#covidvaccine
has received so little public-private support.
No bags, filters, nor any kind of regulatory short-cuts, only impediments.
Should have been approved 6 months ago.
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#Sinovac
63%, not 78% effective
Inactivated
#CovidVaccine
data gets dodgier still as now 'they' apparently cannot even do simple math:
According to numbers (~220 infected, 60 vaccine, 160 pbo)
it's 63% effective, not 78%.
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#IRA
Potentially HUGE development for oligonucleotide therapeutics:
per Novartis CEO, BIPARTISAN bill making good progress on giving gene-targeted therapeutics 13 instead of (small molecule) 9 year protection.
ALSO: drug with multiple, not just 1 orphan indication to be exempt
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$PRQR thanks all that invested along with me (and also those that did not)...and yet nobody dunked on me when stock was languishing.
Today was a big de-risking step; from now on flawless clinical execution.
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$AFMD patient 3 (a CR) was supposed to go to hospice, then received AFM13 loaded onto cord blood-derived NK cells...complete response, now about to receive allogeneic transplant.
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$NVAX 2 days after calling out US/FDA for being in bed with Phizer, VRBPAC member Meissner responds by saying he is 'excited' by prospect of Nuvaxovid in US:
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$NVAX apples-to-apples Novavax has better efficacy than $MRNA and $BNTX $PFE: 95.6% against wild-type strain
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$afmd i've hit my 1% ownership goal. If there will be pandemic of cancer + stock up to $mrna valuations, I'll be a billionaire ahead of schedule :)
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$NVAX next week is going to be BIG:
Japan decision and covid19-flu combo study data at World Vaccine Congress:
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$NVAX public hearing session shaming FDA for withholding vaccine available in most other countries, dishing their citizens up only mRNA.
'Only FDA knows why'.
#VRBPAC
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$arwr OMG..a day for the oligoRx history books: potent (and safe!) target gene knockdown in the lung.
Drops phone....
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$NVAX as a long-time biotech investor, I knew that the FDA was highly conflicted...but
#Novavax
is taking it to a new level.
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$NVAX from tomorrow on, Nuvaxovid will be available in Nova Scotia 🇨🇦 as dose 1, 2, OR 3/BOOSTER, including heterologous.
First agency in the world to allow such broad use (only restriction is age >18 years).
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72
Fell off chair when I revisited cause of the JNJ (adeno-based)
#covidvaccine
trial pause in Oct '20:
CEREBRAL SINUS VEIN THROMBOSIS (in young person).
--> almost certain that
#AstraZeneca
's troubles extend across adenoviral franchise
@matthewherper
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$nvax best-in-class covid and malaria vaccines, first flu-covid vaccine data, 2022-3 APA+ other high-margin funding close to $10B....
.....market cap $3.5B.
A joke.
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$NVAX to be used as booster in Ireland (EU country):
'Minister Donnelly said: “I welcome this update to our booster vaccination programme'
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$nvax booster approval in Australia, incl heterologous
This...is...so...incredibly...important to see such approvals following primary-only approvals.
Future secured.
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Here's hoping the Bill & Melinda Gates Foundation will continue to live on in its current incarnation. Arguably the most impactful org when it comes to addressing health issues in poor countries.
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$NVAX very bullish for next week.
Once market realizes that vaccine not only got approvals, but Co confirms that it's getting cleared+shipped, stock should bounce strongly.
Plus likely approval news from South Korea + Australia.
jmho
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@EricTopol
That's not correct. CVST was seen in JNJ phase 3 trial and was cause of trial halt last Oct:
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$nvax some nuggets from Q&A:
- COGS of $3-5/dose; since many doses already expensed as R&D, there will be 0 COGS doses initially
-SK sitting on 100M doses, ready to go when approved as manufacturing site
- US order not included in 4-5B 2022 rev guidance, represents upside
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$nvax I will be livid if the FDA ends up giving Novavax a narrower label than the mRNAs because of myocarditis.
Never underestimate corruption at agency.
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Variant
#VRBPAC
panel member Adam Berger says that strain-adaptation may only be needed for mRNA platform;
he's impressed by one-size-fits-all-strains Novavax!
$NVAX $BNTX $MRNA
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$ARWR making 5-year lows after best-in-class hypertrig data which open potential to label well beyond small FCS population.
#confused
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$AFMD fan-tastic news for Hodgkin Lymphoma patients and future of cord blood NK-ICE combo for cancer in general:
100% response rate at recommended phase 2 dose, 5 CRs and 7 PRs...safe.
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$NVAX we may be in the middle of perfect storm:
1) adenoviral
#covidvaccines
drop out
2) prices going up
3) US phase 3 results imminent
4) imminent regulatory approvals followed by new orders
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14
71
$NVAX now overtaking $MRNA for 1st, 2nd, 3rd, and 4th shot in Korea 💪. 15-20% market share.
#Phizer
still dominating, late-coming homegrown competition from SK Bio without traction.
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SOOO excited.
#Novavax
is coming to my area. Special vaccination day next week Feb24 if you are in the
#Rastatt
#BadenBaden
area!
$NVAX
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$ARWR big congrats to company. Not 1, but 2
@nejm
publications for 2 different drugs.
Personally, starting to like Zodasiran more and more.
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70
$nvax auhotized in Korea.
50M people. SK added to global supply chain.
Chughahabnida!
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11
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Expert says 200M doses of $NVAX
#covovax
ready to be rolled out in 'Big Way'!
Expert says he's in close contact w/ Serum. Co says >90% effective against
#omicron
!!
Says AZ homologous booster useless, expects
#covovax
to be used as booster, too.
#COVID19
| "The new vaccine
#covovax
from Serum Institute is very effective...currently, most patients we're seeing are asymptomatic": Dr
@PurvezGrant
, Member, Covid Task Force,
#Karnataka
, on rollout of the "precautionary dose" of the
#CovidVaccine
today.
#BoosterJab
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Just talked to person co-ordinating it, says phone ringing off the hook.
Said
#Novavax
seems to have hit a nerve. Nobody wants
#Moderna
or
#Biontech
any more.
$NVAX
SOOO excited.
#Novavax
is coming to my area. Special vaccination day next week Feb24 if you are in the
#Rastatt
#BadenBaden
area!
$NVAX
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$NVAX totally confused abt market reaction to what seem STELLAR data:
- only a bit more than 4x drop in neutralization
#omicron
vs wild-type for 2-dose
- 3rd dose peak responses greatly exceed 2-dose, incl omicron/delta; SAEs comparable to placebo
-great adolescent response
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$NVAX while Moderna and Biontech/Pfizer talk about 20-40x drop in neutralization prototype vs
#omicron
, Novavax maybe 5x...
....and 3rd shot for omicron almost as good as 2 shots for prototype (Moderna sees drop)!
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14
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$NVAX Stan is right to call out corruption of US regulators.
Nothing to lose. They've been laughing their heads off at how quiet Co had been taking this.
+ funny analyst predicting $5B revenues on 2B doses. So
@novavax
will just give it away?
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$arwr Plozasiran (RNAi) reduced triglycerides -79% in both genetic and clinically defined FCS. Huge -95% target ApoC3 knockdown.
$ions olezarsen: -45% TG at high dose that had safety issues.
Because plozasiran was stat sig for TG reductions, they can claim
#pancreatitis
Results from our Phase 3 study of our
#RNAi
therapy for adults with familial chylomicronemia syndrome were presented at
@escardio
#ESCCongress
2024 and simultaneously published in
@NEJM
. Learn more here:
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$NVAX Take-homes:
👉FDA agrees w/ need for mRNA alternative
👉sticking point has been manufacturing quality (not efficacy, safety)
👉Dubovsky (Novavax) says issues solved
👉VRBPAC meeting before approval
👉FDA needs a new travel agent
Novavax says it has resolved the manufacturing problems that delayed U.S. authorization of its Covid-19 vaccine. Health regulators have begun their review.
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Now Reuters 'updates' their article to admit to their omission of the 28M shipped in addition to the 10M Indonesian doses.
Too bad, 90% of those that read original article will never see the 'update'.
How the game is played.
$NVAX
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$NVAX Europe is in the midst of the biggest Covid wave yet...
....but regulators taking their sweet time to approve vaccine that vaccine hesitants are clamoring for.
No rush, no rush...
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65
$arwr a mgmt that has been able to solve delivery for the
#lung
(90%+ kd) years ahead of competition has my full confidence that they are in control of capital needs.
Market reaction last week so non-sensical...as if there was no demand for targeting lung, plus all the other
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10
67
$NVAX Fauci bombshell:
Criticizes short durability of mRNA vaccines.
'Got to do better' --> new platforms, immunogens, MAYBE ADJUVANTS!
Here's the long version where he indicates Novavax to come online soon (~19min):
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10
66
$ARWR whoaaaa.... CEO thinks they are close to SYSTEMIC admin for
#CNS
targets. whoaaa.
to be discussed at investor day.
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65
$NVAX setting the stage for robust fall uptake of its
#covidvaccine
:
2-shot approval adults
--> 2-shot approval adolescents
--> booster approval
--> demonstration that Novavax protein booster superior to mRNAs against emerging variants
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7
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#covidvaccine
CEO of world's biggest vaccine maker, Serum Institute, blasts mRNAs for short-lived protection. Says adenovirus better in this regard.
Due to safety, he says $nvax Covovax needed for young people:
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13
65
LOL. $NVAX released much better data last night. Crickets from Fauci and Gottlieb. Now the expected game-changer rhetoric. Got it, but no thanks.
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$NVAX Germany expects a run on Novavax protein vaccine!
The best tolerated and safe efficacious vaccine- the people's vaccine.
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65
Thank you $NVAX for serving the world, not the EC bureaucrats:
🙏
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62
Anecdotal from family: more are making switch to
#Novavax
as they have been witnessing sometimes severe side effects from mRNA. Not stuff from covidiots on the net.
So far, heterologous boosting without side effect, except for euphoria in my case. $nvax
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$NVAX starting tomorrow, it will be 3 geographies rolling out
#Nuvaxovid
:
Korea 🇰🇷, Australia 🇦🇺, and the EU 🇪🇺.
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$ARWR with INHBE preclinical results. Weight loss while lean mass preserved. $WVE $ALNY
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$ARWR I'm in awe:
crazily efficient mean max TRIG reduction of -95% in severe hypertrig patients following single dose of mere 50mg:
$AKCA doesn't hold a candle.
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More people registered for (primary vaccinations with)
#Novavax
this week alone in German state of Rhineland-Palatinate than primary vaccinations in last 3 months combined!
$NVAX
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$NVAX great,
#Novastans
(🤣), we are already being called a 'cult'. Wouldnt mind becoming embroiled in the next $GME-type short squeeze:
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