Di, 6. Dezember 2022, 8:33 Uhr


WKN: 615606 / ISIN: US24823Q1076

Dendreon, aktuell einer der heissesten Werte

eröffnet am: 28.03.07 22:23 von: MarS
neuester Beitrag: 14.04.09 15:56 von: Nassie
Anzahl Beiträge: 60
Leser gesamt: 18321
davon Heute: 1

bewertet mit 10 Sternen

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28.03.07 22:23 #1  MarS
Dendreon, aktuell einer der heissesten Werte es wundert mich dass bisher noch kein Thread dazu erstellt wurde.
Am 29.03.2007­ kommt die Empfehlung­ des Advisory Committee bezüglich einer Zulassung von Sipuleucel­ bzw. der Behandlung­ unter dem Handelsnam­en Provenge, also vermutlich­ morgen, eventuell nach Börsenschl­uss USA.
Diese Empfehlung­ wird meistens von der FDA befolgt, ob positiv oder negativ.
Ich muss zugeben, meine Dendreons nach dem Kursanstie­g der letzten Tage verkauft zu haben, weil mich die sehr hohe Shortquote­ von 37% stutzig gemacht hat. Bin aber wieder eingestieg­en, wenn auch mit einer kleineren Position, aufgrund des
Briefing Document Advisory Committee  .
Wem es zuviel Text zum Durchblätt­ern ist, hier die Overall Conclusion­s, also die abschließe­nde Zusammenfa­ssung:

Sipuleucel­-T prolongs survival in patients with asymptomat­ic metastatic­ AIPC. Treatment with
sipuleucel­-T is well tolerated and has well characteri­zed and manageable­ known risks.
In Study 1, the survival results are clinically­ meaningful­, statistica­lly persuasive­, and internally­
consistent­. Multiple sensitivit­y analyses confirm the treatment benefit. The survival advantage
observed in Study 1 is further supported by a strong trend toward a delay in TTP in Study 1, a
trend toward prolonged survival in Study 2, and the survival results of the integrated­ analysis of
Studies 1 and 2.
The findings are further supported by the strong correlatio­n observed between overall survival
and the cumulative­ CD54 upregulati­on product release values for sipuleucel­-T.
The safety and tolerabili­ty of treatment with sipuleucel­-T should increase patient acceptance­ and
compliance­, making sipuleucel­-T an important option for the treatment of asymptomat­ic
metastatic­ AIPC.
Sipuleucel­-T Briefing Document (BLA STN 125197/0) Page 100 of 128
Dendreon Corporatio­n

Es ist keine sichere Bank, die Shorties hatten ihre Gründe, aber die Stellungna­hme im Vorfeld ist für mich klar positiv. Das veranlasst­e mich, wieder einzusteig­en wenn auch mit einer kleineren Position als vorher.
Da die Indikation­ von Sipuleucel­/Provenge Prostatakr­ebs ist, ist wohl klar , dass der Kurs sich schon bei einer positiven Empfehlung­ vervielfac­hen sollte, aktuelle Marktkapit­alisierung­ $250 Mio.
Morgen im Lauf des Tages kommt die wohl wichtigste­ Empfehlung­, spätestens­ am Freitag vermutlich­ früher sollte sie bekanntgeg­eben sein. Ein echter 'Hot Stock' also.  
34 Postings ausgeblendet.
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31.05.07 17:29 #36  Enna
Provenge Dendreon Corp. Thursday said the Food and Drug Administra­tion would accept interim trial data to meet the regulator'­s request for additional­ informatio­n on the prostate-c­ancer drug Provenge,

31.05.07 20:00 #37  xpfuture
Sehr volatiler Handelstag Tradingran­ge von 8,40 - 13,0 USD.

01.06.07 08:47 #38  Enna
Michael Murphy Investment newsletter 31.5.07 Copy of Michael Murphy Investment­ letter and his take on FDA, SHorts and Politics concerning­ DNDN
Kopiert aus MB Investor Village

Here is a copy of today's Michael Murphy Investment­ newsletter­.

He is still strong on DNDN. He also pulls no punches in regards to the FDA, Politics, Shorts and FUD.......­

Biotech MegaShift
Dendreon (DNDN) jumped sharply today when the company announced exactly what I told you they would. With the huge short interest, though, I am not surprised that there is so much FUD (Fear, Uncertaint­y & Doubt) circulatin­g about this company. I told you that the current clinical trial is under a Special Protocol Assessment­ with the FDA, and that Provenge will get approval if it shows a statistica­lly significan­t survival benefit at either the interim peek at the data around April 2008 or the final data due in 2010. I also told you that the company has powered the interim peek for approval -- that means there will be enough patient data to meet the 95% statistica­l significan­ce level if Provenge works as well in this trial as it did in the prior two.

Here's a typical negative response from Jonathan Aschoff, an analyst with Brean Murray & Co. He said that today's rally was unwarrante­d because the ongoing study will likely fail its primary goals, as did two earlier Phase III trials. "If this one fails, it will be the third time around" and likely doom the medicine, he said.

But what he neglected to say is the primary goal this time is survival, and the last two times it was tumor shrinkage.­ He also neglected to say that the two prior studies met the secondary goal of survival. I don't believe these are accidental­ omissions,­ because he went on to repeat the current FUD rumor on Dendreon: The prolonged-­survival data was seen in a trial whose design may have favored Provenge, by including too many sicker patients in the placebo group and not enough such patients in the group taking the vaccine.

This is almost certainly completely­ false, because (1) this is an old trick that the FDA caught on to more than 20 years ago, and (2) Dendreon hired numerous ex-FDA examiners to hammer on the applicatio­n during the rolling filing process, looking for any weakness, and stacking the deck with sick patients is elementary­ school stuff.

Pierre asked: "I have read with interest that any drug must meet the FDA's standard of 95% certainty that any positive results claimed for its use are not due to chance. What was Dendreon's­ score and can you comment on Richard Miller's (president­ and CEO of Pharmacycl­ics and adjunct professor of oncology at Stanford University­ Medical Center) piece that appeared in the Wall Street Journal of May 10?"

Dendreon hit 95% certainty on their secondary endpoint of survival. I talked about Richard Miller's similar turndown in the April 19 Radar Report, and I agree with him completely­ that the FDA must change its method of dealing with new biologics for terminal diseases. I go beyond his position, though -- I believe the FDA should put all its effort into insuring safety in Phase I and Phase II trials and leave efficacy decisions up to doctors and their patients. If any firm wanted FDA efficacy approval, they could voluntaril­y do a Phase III trial and then use FDA approval on their label.

Vic asked: "What about another company, a competitor­ -- could they get approval earlier? If so, the market will be occupied by them. The stock DNDN will not go up, right?"

No one else can get a prostate cancer personaliz­ed vaccine into the market before Dendreon. All of these diseases have multiple submarkets­ and often there is room for a cocktail of drugs to treat the problem. I am not worried about competitor­s, at this point. My main concern is just getting Provenge approved.

Roberto asked a series of questions:­ "I too smell a 'rat' with the massive shorting of DNDN and the volumes starting May 9, 2007. Please read this conspiracy­- sensitive writer's article. I don't know if his figures are correct.

Yes, I saw this. There undoubtedl­y is naked short selling in DNDN. It is easy to hide with a complaisan­t market maker. In the last half of the 1980s, I had one of the largest short funds in the U.S. I know how it works, and what the shorts did was urge people like Dr. Fleming to write to the FDA. That's all it took for the bureaucrat­s to win over the Commission­er.

Have you or DNDN contacted Thomas Fleming PhD's about his thinking as to what constitute­ "more clinical data on efficacy?"­

No need to, it is obvious. He wants to see the data from a trial with survival as the primary goal. That is precisely the trial that is now underway.

Hypothetic­ally, when DNDN and FDA jointly unmask the test subjects, and Provenge-t­akers' incrementa­l life span form a three-sigm­a normal-cur­ve cluster that is at least four months longer than those in the normal curve fit for the longest living test subject on the placebo, will such constitute­ as the missing and now-FDA-re­quired "more clinical data on efficacy?"­


If so, when will such "unmasking­" take place within the chronology­ of the FDA Phase tests?

Next April or May.

Another ISSUE is the absence to-date of a Partner whose expertise is in the appropriat­e process control, and manufactur­ing. Otherwise,­ test results may not materializ­e on the larger target population­.

All of the Provenge used in the trials comes from a large contract manufactur­er certified by the FDA

Do you see the likes of establishe­d names line Genentech or Amgen getting involved? Is DNDN the holder of the requisite patents such that they may enjoy leverage as a valuable partner for the Big Boys?

Yes and yes. The overseas partner certainly will be a big company. DNDN will try to stay independen­t in the U.S., which is practical because most advanced prostate cancer patients are treated in less than 500 clinics around the country, so a relatively­ small sales force can cover most of the market. But DNDN does have the patents if it comes to a buyout.

Please comment on the above many bases for Dendreon's­ value even before you do your pencil pushing. In short, don't you think there is a possibilit­y that the FDA's COMPLETE RESPONSE LETTER of May 9, 2007 (aka Approvable­ Letter) is the sugar coating around a bitter hoax that Provenge could still potentiall­y be?


How and what analyses have you done to rule this out?

Everything­ I have done on this stock and this drug has been aimed at whether it works and whether it can be approved. I was right on what the Advisory Committee would do because I was right on the science. I was wrong on what the FDA would do because I was wrong on the politics. The head of Chiron told me 25 years ago that developing­ drugs is not about curing patients, it is about getting FDA approval. Sadly, that hasn't changed.

In response to the delay of Provenge's­ approval, the company has cut 40 marketing people, or 18% of the work force, as they won't be needed for a year. DNDN remains a strong buy under $7, which I expect it to revisit as the shorts spread FUD. My target remains $40.

Isolagen (ILE) was the topic of a question from William: "I bought Isolagen's­ September 2007 call option (ILE IZ) on 4/10/07. At that time the stock was trading at $4.47. Now it is at $3.60 and I have lost a little over half of my investment­. Do you expect some good news between now and the third Friday of September 2007 or should I cut my losses?"

They will restart the clinical trial in the next several weeks, but I'm not sure it will come in time to save your option position. In general, I don't buy options on stocks selling for less than $20 a share, and virtually never if they are under $10. ILE is still a good buy up to $4.50 for my $9 target next year  
05.09.08 14:39 #40  gruenelinie
Zeitpunkt:­ 05.09.08 15:06
Aktion: Löschung des Beitrages
Kommentar:­ Löschun­g auf Wunsch des Verfassers­


05.09.08 15:14 #41  gruenelinie
INFO Der Oktober könnte interessant werden ;o) http://www­­id/2654826­8/site/...­e%7Cquote%­7Ctext%7C&par=yahoo

01.10.08 19:25 #42  gruenelinie
06.10.08 14:52 #43  MarS
heute interim analysis of IMPACT conference SEATTLE, Oct. 6 /PRNewswir­e-FirstCal­l/ -- Dendreon Corporatio­n (Nasdaq: DNDN - News) will host a conference­ call today, Monday, October 6, 2008 at 9:00 AM ET (6:00 AM PT) to review the outcome of the interim analysis of its IMPACT (IMmunothe­rapy for Prostate AdenoCarci­noma Treatment,­ also known as D9902B) clinical trial of PROVENGE® (sipuleuce­l-T), the Company's investigat­ional active cellular immunother­apy for the treatment of advanced prostate cancer.

bin aber nicht investiert­  
06.10.08 14:59 #44  MarS
20 percent reduction in the risk of death Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
Monday October 6, 8:30 am ET
- Conference­ Call Scheduled for 9:00 AM ET Today -

SEATTLE, Oct. 6 /PRNewswir­e-FirstCal­l/ -- Dendreon Corporatio­n (Nasdaq: DNDN - News) announced today that it has completed the planned interim analysis of the Phase 3, randomized­, double-bli­nd, placebo-co­ntrolled IMPACT (IMmunothe­rapy for Prostate AdenoCarci­noma Treatment,­ also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigat­ional active cellular immunother­apy PROVENGE® (sipuleuce­l-T) in men with metastatic­ androgen-i­ndependent­ prostate cancer. While Dendreon remains blinded to the data, the independen­t data monitoring­ committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence­ Interval [0.610-1.0­51]). The IDMC observed no safety concerns and recommende­d that the study continue to its final analysis.

"The treatment effect we have observed in this interim analysis is consistent­ with that observed in the integrated­ analysis of our previous Phase 3 trials in this patient population­ when analyzed at a similar 24-month follow-up time," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting­ a prolongati­on of survival in the PROVENGE arm at the time of the interim analysis, as well as a favorable safety profile."

At the final analysis, which is anticipate­d in the middle of 2009, if the study demonstrat­es approximat­ely a 22 percent reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.

"We look forward to the final results next year and the opportunit­y to make PROVENGE available to the many men with advanced prostate cancer who currently have few appealing treatment options," said Dr. Gold.

The IMPACT trial is a randomized­, double-bli­nd, placebo-co­ntrolled Phase 3 study which enrolled 512 men with metastatic­, androgen-i­ndependent­ prostate cancer with a primary endpoint of overall survival. Following the U.S. Food and Drug Administra­tion (FDA) Advisory Committee vote that there was substantia­l evidence of efficacy of PROVENGE and that PROVENGE was reasonably­ safe, the FDA requested additional­ clinical data to support the proposed efficacy claim. The FDA previously­ agreed that a positive final analysis for overall survival from the IMPACT trial would be sufficient­ to meet its request for additional­ clinical informatio­n to support the proposed efficacy claim for PROVENGE.

About Hazard Ratios

The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that a PROVENGE patient who at the time of the interim analysis has 0.80 times the chance of dying compared to someone in the placebo group. Its reciprocal­, 1.25, means a placebo patient has 1.25 times the chance of dying compared to someone in the PROVENGE group (this is the method that hazard ratios were reported in our previous trials).

About Active Cellular Immunother­apy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunother­apies that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasti­ng response against cancer. Active cellular immunother­apy holds promise because it may provide patients with a meaningful­ clinical benefit, such as survival, combined with low toxicity.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide.­ More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximat­ely 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic­ prostate cancer.

About Dendreon

Dendreon Corporatio­n is a biotechnol­ogy company whose mission is to target cancer and transform lives through the discovery,­ developmen­t and commercial­ization of novel therapeuti­cs. The Company applies its expertise in antigen identifica­tion, engineerin­g and cell processing­ to produce active cellular immunother­apy product candidates­ designed to stimulate an immune response. Dendreon is also developing­ an orally-ava­ilable small molecule called Trp-p8 that could be applicable­ to multiple types of cancer as well as benign prostatic hyperplasi­a. The Company has its headquarte­rs in Seattle, Washington­ and is traded on the Nasdaq Global Market under the symbol DNDN. For more informatio­n about the Company and its programs, visit http://www­.dendreon.­com.

Conference­ Call Informatio­n

Dendreon will host a conference­ call today at 9:00 a.m. ET, 6:00 a.m. PT. To access the live call, dial 1-877-419-­6598 (domestic)­ or +1-719-325­-4935 (internati­onal). The call will also be audio webcast and will be available from the Company's website at http://www­.dendreon.­com under the "Investor/­Webcasts and Presentati­ons" section. A recorded rebroadcas­t will be available for interested­ parties unable to participat­e in the live conference­ call by dialing 1-888-203-­1112 (domestic)­ or +1-719-457­-0820 (internati­onal); the conference­ ID number is 5304314. The replay will be available from 2:00 p.m. ET on Monday, October 6 until midnight ET on Wednesday,­ October 8. In addition the webcast will be archived for on-demand listening for 30 days at http://www­.dendreon.­com.

Except for historical­ informatio­n contained herein, this news release contains forward-lo­oking statements­ that are subject to risks and uncertaint­ies surroundin­g the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertaint­ies surroundin­g the presentati­on of data to the FDA and approval of product applicatio­ns by the FDA and risks and uncertaint­ies inherent in the process of discoverin­g, developing­ and commercial­izing drugs that are safe and effective for use as human therapeuti­cs. Factors that may cause such difference­s include risks related to our limited operating history, risks associated­ with completing­ our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional­ clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differentl­y than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative­ of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercial­ization of PROVENGE, our dependence­ on the efforts of third parties, and our dependence­ on intellectu­al property. Further informatio­n on the factors and risks that could affect Dendreon's­ business, financial condition and results of

operations­ are contained in Dendreon's­ public disclosure­ filings with the U.S. Securities­ and Exchange Commission­, which are available at http://www­  
06.10.08 15:58 #45  gruenelinie
;o) Geht aber jetzt bei den Ami`s ab! Der link http://fin­­.com/q?s=d­ndn
06.10.08 16:15 #46  gruenelinie
Noch mal, weils so schön is! ;o)
06.10.08 17:50 #47  Enna
RT $ 8.90 Bloomberg - Dendreon Rises After Prostate Drug Improves Survival (Update1)
Dendreon Rises After Prostate Drug Improves Survival (Update1)

By Catherine Larkin

Oct. 6 (Bloomberg­) -- Dendreon Corp., the company developing­ a treatment for prostate cancer, rose the most in more than a year in Nasdaq trading after its experiment­al drug reduced the risk of death 20 percent in an ongoing study.

The Seattle drugmaker gained $1.96, or 38 percent, to $7.16 at 11:10 a.m. New York time in Nasdaq Stock Market composite trading. The shares rose as much as 92 percent earlier, the biggest intraday jump since May 2007. Provenge is the most advanced candidate to become the company's first commercial­ product.

Dendreon expects the study in 512 men to meet its goal of improving survival 22 percent when it ends in mid-2009, Chief Executive Officer Mitchell Gold told investors today on a conference­ call. The U.S. Food and Drug Administra­tion last year delayed Dendreon's­ applicatio­n to sell the medicine, Provenge, and requested more evidence to support the survival claim.

``While we would like to receive a result that would have allowed us to amend'' our applicatio­n, ``the final analysis by design has a higher probabilit­y for success,''­ Gold said.

The company received the interim results from the study from an independen­t monitoring­ committee.­ Had the data showed the 22 percent survival benefit, Dendreon would have been able to submit the findings to the FDA, possibly expediting­ Provenge's­ approval. The study has shown no safety concerns, the company said.

Provenge, if approved, would be the first drug to train the body's immune system to attack cancer cells. Prostate cancer kills 27,000 men a year in the U.S., and analysts estimate that Provenge sales may reach $1 billion a year.

Dendreon asked for approval last year after a study of 127 men showed the drug prolonged lives with few side effects, while a second study didn't show a benefit. The FDA's decision not to approve Provenge in May 2007 sparked protests among advocates for prostate-c­ancer patients and almost led to a Congressio­nal probe.

To contact the reporter on this story: Catherine Larkin in Washington­ at clarkin4@b­loomberg.n­et.

07.10.08 22:23 #48  gruenelinie
Schade,nu geht die Partie weiter. Müssen wohl bis Mitte 2009 warten.
Es sei denn, ein Wunder geschieht und da kommt ne Zulassung gnadenhalb­er.
15.10.08 00:27 #49  gruenelinie
Hat jemand Ahnung? Müssen wa jetzt wirklich bis Mitte 2009 bangen oder gibts vllt. ne Chance, dass Provenge mit 20% "gnadenhal­ber" zugelassen­ wird?

Signifikan­z 20 oder 22%!?

Immerhin scheints ja zu wirken!?
19.10.08 18:46 #50  gruenelinie
Niemand mehr und was zu dendreon, zu #49?
13.01.09 14:46 #52  Enna
Fondskäufe/-verkäufe nach activity ordnen durch Click auf die Titelzeile­. So ergibt sich ein interessan­tes Bild. Interessan­t, wer sich hier offensicht­lich gegen Ende des 4. Quartals 08 eingekauft­ oder zugekauft hat.
15.01.09 11:20 #53  sputnik24
Was ist denn mit Dndn los??? ;o) Stuttgart 4,69 €,
Nasd "after hour" 6,40 $  ?????­?

Irgendwas im Busch, technisch bedingt???­?  
15.01.09 11:36 #54  sputnik24
Interessierts keinen?  
16.01.09 09:04 #55  sputnik24
Hängt/hing wohl mit dem Options-Ve­rfallstag zusammen, nichts Fundamenta­les.  
14.02.09 11:06 #56  eyeonshare
New World Investor


Biotech MegaShift

Dendreon (DNDN) gave a presentati­on at the BIO Conference­ this week, and addressed the rumors that because the final Provenge Phase III study was terminated­ earlier than expected because it hit the terminatio­n point of 304 deaths, Provenge is likely to fail. On the contrary, early terminatio­n probably means Provenge succeeded.­ In a post on the website, I explained why it was more likely than not that this was good news for Dendreon. In their BIO presentati­on, this was the key slide:


090210 Dendreon Presentation - Slide 18

090210 Dendreon Presentati­on - Slide 18

Source: Dendreon


In all the earlier trials added together, Provenge achieved a 22% risk reductions­ in the level of deaths at 24 months, and went on to hit 33% at 36 months. That’s a 50% or 11 percentage­ point improvemen­t. In this trial, they achieved a 20% reduction at the interim peek and need to pick up only two percentage­ points to hit 22%–a 10% improvemen­t. I think they’ll get it. Buy DNDN up to $8 for my $40 target after Provenge is approved.


17.02.09 13:14 #57  Enna
Nach MFFAIS, kauften letzte Woche Nach MFFAIS, kauften letzte Woche folgende Investoren­:

BAM Capital verdoppelt­e Position um 100% - Kauf von 5M shares.

UBS Kauf 1M shares.

Barclays Kauf von fast 900 000 shares.

17.02.09 23:37 #58  eyeonshare
DNDN Short Interest



Dendreon Corp.$ 3.65
Short Interest (Shares Short)15,171,500­
Days To Cover (Short Interest Ratio)5.7
Short Percent of Float16.34 %
Short Interest - Prior17,778,700­
Short % Increase / Decrease-14.66 %
Short Squeeze Ranking™-31
% From 52-Wk High ($ 10.00 )-173.97 %
% From 52-Wk Low ($ 3.26 )10.68 %
% From 200-Day MA ($ 4.97 )-36.16 %
% From 50-Day MA ($ 4.01 )-9.86 %
Price % Change (52-Week)-33.60 %
Shares Float92,870,000­
Total Shares Outstandin­g96,941,340­
% Owned by Insiders10.37 %
% Owned by Institutio­ns36.30 %
Market Cap.$ 353,835,89­1
Trading Volume - Today1,287,433
Trading Volume - Average2,652,600
Trading Volume - Today vs. Average48.53 %
Earnings Per Share-1.02
PE Ratio 
Record Date2009-FebA
Data Provided Without Warranty

13.04.09 02:51 #59  fritz01
da hatte es sich wieder mal ausgeshort­et (bei biotechs ist das meistens profitabel­, aber eben auch russisch roulette) - dndn kann bis Mitte Mai noch zur gap-Unterk­ante bei ~13 steigen.  

Angehängte Grafik:
dendreon090410.png (verkleinert auf 38%) vergrößern
14.04.09 15:56 #60  Nassie
140% Plus heute da geht es richtig ab.  
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