AEZS Transformation zum Big Player


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Eröffnet am:16.12.16 23:48von: boreasAnzahl Beiträge:3.883
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4692 Postings, 3101 Tage ROI100Heron, ändert aber nichts, dass Du bei anderen

 
  
    #2751
1
12.05.17 08:18
kritisierst ihre Beiträge hätten keine Bezug zum Thread oder Invest und selber es ständig machst. Also nicht ablenken. Du hast Dir ein Eigentor geschossen was jeder jetzt hier lesen kann.  

24124 Postings, 5662 Tage HeronROI

 
  
    #2752
12.05.17 08:25
Lieber ein Eigentor schiesen, als die Fahne permanent in den Wind drehen,

haste das Verstanden.

Bin "kein" Wendehals, und auch nicht Fehlerfrei, nur verarsche ich die Leute nicht in meinen Threads.  

4692 Postings, 3101 Tage ROI100Unicorn, das finde ich aber gar nicht erstaunlich.

 
  
    #2753
1
12.05.17 08:25
Ich finde bei Solarworld konntest Du schon seit einiger Zeit davon ausgehen, dass dies geschieht. Ja fast schon seit einem halben Jahr. Es war nur noch die Frage wann statt ob. Bei Aetrna haben die meisten Leute es erst gemerkt nachdem Zopt gefloppt hat. Also steht Aeterna jetzt an dem Punkt wo Solarworld vor einem halben Jahr stand. Jetzt gibt es auch nur die Frage wann statt ob.

Ergo hat man bei Solarworld angefangen zu zocken. Die ganzen kleinen Zocker sind aus ihren Löchern gekommen um kurze Gewinne zu machen. Das wird hier auch passieren, wie hier etliche eschreiben hoffen sie ja genau hier auch darauf, um besser rauszukommen. Beide Werte sind nur noch Spielball der Zocker. Es ist nichts mehr vorhanden was nachhaltig für ein lohnendes, längeres Investment lohnt. Auch Mac reicht dafür nicht aus. Der Markt ist viel zu klein.  

24124 Postings, 5662 Tage HeronHeut ist Freitag,

 
  
    #2754
12.05.17 08:26
Vorbereitung auf das WE,

Steaks und Co warten.  

4692 Postings, 3101 Tage ROI100Heron, was fühlst Du Dich jetzt so angegriffen?

 
  
    #2755
1
12.05.17 08:29
Also ich habe meine Fahne noch nie nach dem Wind gehangen. Wenn bei einem Investment Sachverhalte auftreten, die ein Überdenken dieses rechtfertigen dann macht das ein jeder Investor. Denn er hinterfragt sein Investment. Sind Grundlagen des Investings.

Ich habe auch nie gesagt, dass Du Leute verarschst, also was soll das jetzt? Ich habe auch nie gesagt das Du an irgendetwas schuld bist. Ausser spaßeshalber als ich geschrieben habe, dass Du an allem schuld bist. Aber ich hoffe mal das ihr keine Sheldons seid und Sarkasmus erkennt.

Fühlst Du Dich erwischt als Ossi? Denn Deine Reaktion ist wohl eindeutig.  

24124 Postings, 5662 Tage HeronWas bellsten so rum, ROI

 
  
    #2756
1
12.05.17 08:34
Ich sag meine Meinung, zu der ich steh,

und

DU Spamst eben ab morgens 8:00 die Threads gern voll.

Sag nur Paion,  A und B Thread,

LOL  

4692 Postings, 3101 Tage ROI100War das jetzt ein inhaltlicher Post zu Aeterna?

 
  
    #2757
12.05.17 08:35

24124 Postings, 5662 Tage HeronDanke, Ariva Mods

 
  
    #2758
12.05.17 09:08

26 Postings, 2524 Tage Gadzid12Der Rauch hat sich verzogen

 
  
    #2760
2
22.05.17 19:20
Zeit mal hinzuschauen,warum ich und vielleicht auch andere so tief ins klo greifen konnten...
Klar ist,entsprechend obigem Transkript,außer dem OS und der Kardiotoxität haben sie noch keine weiteren Daten zum Zeitpunkt der Veröffentlichung vorliegen gehabt.
Hinzu kommt,ein knappes Drittel der Studienteilnehmer lebten noch zum Zeitpunkt der OS Berechnung.
Ich persönlich könnte mir vorstellen,daß zum Beginn der Studie die Studienzentren,wie dies oft der Fall ist,ihre am  schwersten Erkrankten und  mithin dringlichsten Patienten behandelt haben.-wir erinneren uns an die hohen Sterberaten zu im ersten Jahr der Studie-.
Möglicherweise so schwer krank,daß auch Zoptrex ihnen keinen Überlebensvorteil verschaffen konnte.
Ich spekulier mal und sag,der Laden wird billigst verkauft und irgendwann in Anschluß hört man dann,na,wir haben nach Ablauf der Beobachtungsphase noch mal genauer in die Daten geschaut-,und siehe,das gibts doch nen Benefit für die Behandelten...  

778 Postings, 2814 Tage InselkeysBlödsinn,

 
  
    #2761
22.05.17 19:27
deshalb angemeldet.....  

6834 Postings, 4879 Tage philipofür dich vielleicht

 
  
    #2762
22.05.17 19:58
melde du mal,hast wohl nichts bessres zu tun??  

24124 Postings, 5662 Tage HeronNa, philipo

 
  
    #2763
1
22.05.17 20:17
Haste nochmal Glück gehabt, mit deiner Short-Posi...

 

6834 Postings, 4879 Tage philipo@Heron

 
  
    #2764
22.05.17 21:00
ich war mehrmals investiert und habe nochmals letzmalig 70% verloren,insgesamt habe ich wohl über 100% verloren.  

524 Postings, 3110 Tage Magnus123Verlust

 
  
    #2765
2
22.05.17 21:13
Wie kann man denn mehr als 100% verlieren? Will ich auch mal schaffen^^  

24124 Postings, 5662 Tage Heron@philipo

 
  
    #2766
22.05.17 21:30
Über 100% Verlust bei deiner über 25 jährigen Börsenerfahrung, da muß Oma aber immer wieder mal an....

gegangen sein.  

6834 Postings, 4879 Tage philipoja @Magnus@Heron

 
  
    #2767
22.05.17 21:41
ich weiß, ihr habt es besser drauf,war ja klar......schön für euch.

der verlust hört sich groß an,ist aber zu verschmerzen.



 

23601 Postings, 6170 Tage Chalifmann3Resümee

 
  
    #2768
23.05.17 01:08
laut Boreas sollte das hier ein Big Player mit mindestens 10 MRD Dollar Börsenwert erden ! Ich hätte zu jeder Zeit unterschrieben,dass es das nicht wird,und zwar nie und  nimmer ! Das hat nicht mal ACADIA (ACAD) geschafft,aber das war sehr lehrreich für mich,denn die ACAD Aktie ist schon während der zweiten Phase-3 Studie massiv gestiegen,da wussten offenbar viele Insider,das das ein Erfolg wird,AEZS ist nie gestiegen,zu keiner Zeit und gefloppt,leider shorte ich aus Prinzip keine Aktien.

Wer Interesse an weiteren Formulationen und Variationen von Doxorubicin hat,schaut bei Endocyte (ECYT) und CytRx (CYTR) vorbei,die machen das nämlich und bereiten grade ihre Zulassungsanträge vor .......

Hopfebn und Malz ......  

21958 Postings, 4184 Tage silverfreakyJa hier gibts Leute

 
  
    #2769
23.05.17 09:30
die erzählen was von Gutmenschentum und erfreuen sich nachher noch wenn andere durch ihr Geschwafel Geld verloren haben.Widerlich so was.  

24124 Postings, 5662 Tage Heron@silverfreakly

 
  
    #2770
1
23.05.17 09:35
Sei doch ehrlich, bist nur stinkesauer, weil du nicht wie bei deinen "Minen OTC" Werten einen Ten-Bagger eingefahren hast.

Ich von meiner Seite habe immer auf "Risiko-Management, und Bio-Tech Hot Stock hingewiesen.

Jedenfalls in meinen Aeterna Forum.  

187 Postings, 2600 Tage LukullusErklärungen:

 
  
    #2771
1
23.05.17 14:38

Therapeutic area

Oncology
Target indication

Endometrial
Development stage

Completed
Description

Zoptrex™ is a targeted cytotoxic peptide conjugate under development for several cancer indications. Zoptrex™ is composed of a synthetic peptide carrier targeting the LHRH receptor and the well-known cytotoxic agent, doxorubicin. Zoptrex™ represents the new chemical entity (NCE) Zoptarelin doxorubicin providing targeting aspects similar to other modern therapies such as antibody-drug conjugates.

The design of Zoptrex™ allows for the specific binding and uptake by LHRH receptor positive tumors of which examples include ovarian, endometrial, TNBC, prostate, and bladder. The binding of Zoptrex™ to cancerous cells expressing these receptors is followed by internalization and release of the cytotoxic drug, doxorubicin, in the cells. Since cytotoxic conjugates are designed to target specific cells and accumulate in the malignant tissue, they should be more effective and have less side-effects than the respective non-conjugated/non-linked cytotoxic agents in inhibiting tumor growth.

Zoptrex™ is the first drug in a clinical study that targets the cytotoxic activity of doxorubicin specifically to LHRH-receptor expressing tumors.
FAQs regarding the ZoptEC Phase 3 Clinical Trial of Zoptrex™ as of May 17, 2017

http://ir.aezsinc.com/press-release/...e-3-clinical-study-zoptrex-did

Q.        Was ZoptEC a large Phase 3 study?  When did it begin?

A.         Yes.  The study involved approximately 512 patients and was conducted at approximately 125 medical centers in North America, Europe and Israel.  We announced on July 31, 2013 that the first patient had been recruited and dosed.  Dosing was completed in December 2015.

Q.        The design of the study permitted patients who were randomized into the Zoptrex™ arm to receive up to nine cycles of the compound at a dose of 267 mg/m2.  Patients randomized into the doxorubicin arm received 60 mg/m2 up to a cumulative lifetime dose of 550 mg/m2.  Why was the dose of Zoptrex™ so much larger than the dose of doxorubicin?

A.         The recommended dose for ZoptrexTM was established at the highest tolerable dose as evidenced by dose-limiting hematotoxicity studies and contained a concentration of doxorubicin that was slightly increased compared to the dose of doxorubicin given to patients in that arm of the study.

Q.        What did the DSMB say following its second interim review of the preliminary data from the ZoptEC trial?

A.         The DSMB stated:  “There are currently no safety concerns noted by the Committee nor is there any significant reason based upon efficacy differences to justify discontinuation of assigned therapy in the 43 patients who remain on active therapy.”

Q.        Why did the DSMB permit the trial to continue?

A.         We believe that the DSMB permitted the trial to continue because the data they examined suggested that there was a chance that Zoptrex™ could achieve its primary endpoint.

Q.        The trial was stopped and the median overall survival was calculated following 384 events.  How many patients were in the Zoptrex arm of the trial when the trial was stopped?  Is it correct to assume that the remaining patients were in the doxorubicin arm?

A.         Of the 384 events, 196 were enrolled in the Zoptrex™  arm and 188 in the doxorubicin arm.  When the trial was stopped, 60 and 67 patients were still alive in the Zoptrex™ and in the doxorubicin treatment arms, respectively.

Q.        A total of 512 patients were enrolled in the trial, yet it was stopped at 384 events.  Why?

A.         The study was designed to achieve a high level of statistical confidence following 384 events.

Q.        If 127 patients were surviving when the study was stopped, weren’t they excluded from the calculation of median overall survival?

A.         For the construction of survival time probabilities and curves, the survival times for individual subjects are arranged from the shortest to the longest, without regard to when they entered the study. By this procedure, all subjects within the group begin the analysis at the same point and all are surviving until something happens to one of them. The two things that can happen are: 1) a subject can have the event of interest or 2) they are censored.

           Censoring means the total survival time for that subject cannot be accurately determined. This can happen when something negative for the study occurs, such as the subject drops out, is lost to follow-up, or required data is not available or, conversely, something good happens, such as the study ends before the subject had the event of interest occur, i.e., they survived at least until the end of the study, but there is no knowledge of what happened thereafter.

In the case of the ZoptEC study, the median survival time was computed taking into account the patients who were censored because they were still alive at the end of the study.  The computation was performed using a common statistical tool called the “Kaplan–Meier estimator”.  An explanation of this tool is beyond the scope of this document.  Suffice it to say, however, that the Kaplan–Meier estimator is one of the most frequently used methods of survival analysis because it is useful to examine recovery rates, the probability of death, and the effectiveness of treatment.

Q.        How do you explain the delay in the completion of the trial?  You announced during the fall of 2016 that the rate of events had slowed greatly.  How do you explain that?

A.         Whereas recruitment and treatment period were performed according to plan and reached the anticipated milestones, the follow-up phase after completion of treatment and until the 384 events were reached was longer than initially estimated based on reasonable assumptions and statistical prediction.  In other words, the length of time it took to actually complete the trial was longer than was originally estimated.

Q.        How is it possible that the median overall survival of participants was only 10.9 months for Zoptrex™, considering (i) the last patient admitted to the trial received his or her final dose of the assigned therapy in December 2015; (ii) the 384th event did not occur until around the end of January 2017; and (iii) at that time, 127 patients were still alive?

A.         In our study, median overall survival is the length of time from the respective date of patient randomization, when half of the patients in a treatment arm are still alive.

Q.        Is it true that patients whose tumor did not express the LHRH receptor were enrolled in the study?  Why?

A.         It is true that patients whose tumor may not express the LHRH receptor were enrolled in the study.  This was done because the FDA required us to admit all patients with the disease specified in the protocol.  There were two reasons for the FDA’s position.  First, at the start of the trial there was no validated companion diagnostic tool available to determine whether a tumor expresses the LHRH receptor (and we were not able to develop such a tool during the trial).  Second, the consensus among oncologists is that most tumors associated with the disease specified in the protocol express LHRH receptors.

Q.        Is it possible that some undetected differences between the patients in the Zoptrex™ arm of the study and the doxorubicin arm of the study caused the study to fail?

A.         We do not believe so.  The study populations in both treatment arms were remarkably similar in all aspects:  age, weight, ethnicity and history and stage of endometrial cancer.

Q.        Mr. Dodd made a point of mentioning during a conference call that patients might have received treatment with another therapy in addition to either Zoptrex™ or doxorubicin.  Do you have any evidence that this happened?  If it did, could the outcome of the study have been influenced?

A.         Anticancer therapy in addition to Zoptrex™ and doxorubicin was excluded per study protocol.  However, post-study anticancer therapy at the discretion of the respective investigator was an option.  This means that following completion of the dosing of either Zoptrex™ or doxorubicin, the investigator had the option of providing additional anticancer therapy to the respective patient.  However, since we do not have an indication that post-study anticancer therapy varied in the treatment arms, it is unlikely to have influenced the outcome of the study biased for one treatment arm, only.

Q.        You announced in January that you had a very positive pre-NDA meeting with the FDA regarding Zoptrex™.  How could you have had such a positive meeting if the results of the study were so negative?

A.         The January meeting was a pre-NDA meeting, the purpose of which was to discuss the presentation of data in the NDA.  The results of the study were not discussed with the FDA during the January meeting because the results were not known at that time.

Q.        When did you first learn of the results of the study?

A.         After the close of business in Germany on April 28th.

Q.        Why did you decide to halt further work on other indications for Zoptrex™?

A.         We made this decision because the outcome of the ZoptEC trial placed significant doubt on the concept for the mode of action of Zoptrex™.  The doubt is so strong that we don’t think that expenditure of substantial funds to pursue other indicatives is warranted.  Instead, we will use our remaining funds to pursue the successful regulatory approval and commercialization of Macrilen™.

Q.        Will the results of the study be published in a scientific journal?

A.         Yes.  The investigators of the study intend to publish the results of the study in appropriate medical scientific journals. Aeterna Zentaris will support them in such efforts.
 

187 Postings, 2600 Tage LukullusVerarschung

 
  
    #2772
23.05.17 14:42
das ist doch oberfaul.....
denke Zopt gibts gar nicht. Die haben Dox mit Dox verglichen......

DSMB ???

 

18383 Postings, 5858 Tage TrashWer

 
  
    #2773
23.05.17 14:55
hatn das beantwortet ? SACKse oder Theo-dilu-dore ?

187 Postings, 2600 Tage LukullusDas

 
  
    #2774
23.05.17 15:13
War bestimmt der Doddeldepp...:)  

4686 Postings, 3741 Tage centsucherZopt

 
  
    #2775
4
23.05.17 19:55

Q.        Is it possible that some undetected differences between the patients in the Zoptrex™ arm of the study and the doxorubicin arm of the study caused the study to fail?

A.         We do not believe so.  The study populations in both treatment arms were remarkably similar in all aspects:  age, weight, ethnicity and history and stage of endometrial cancer.

Fehlt noch der TFI! :-)))

The computation was performed using a common statistical tool called the “Kaplan–Meier estimator”.

Der berechnet die Überlebenden anhand der Daten der verstorbenen.

Das funzt aber nur, wenn vorausgesetzt wird, das alle die selbe Lebenserwartung haben.

Oder alle Patienten an einem Tag in die Studie aufgenommen werden.


Ich weiche nicht von meiner Meinung ab. Ohne eine TFI Unteranalyse glaube ich denen gar nichts!!!





 

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