Epigenomics auf dem Weg zur FDA Zulassung?!
Man kann auch mit anderen Aktien Verlust machen! Und schau dir doch mal das Ranking hier bei ariva bei den Tradern an, die größte Zahl der Trader mit Verlust!
1. Angaben zum Emittenten
Epigenomics AG
Geneststraße 5
10829 Berlin
Deutschland
2. Grund der Mitteilung
Erwerb/Veräußerung von Aktien mit Stimmrechten
Erwerb/Veräußerung von Instrumenten
Änderung der Gesamtzahl der Stimmrechte
X Sonstiger Grund:
Umstrukturierung des Konzern-Anteilsbesitzes an der Epigenomics AG
3. Angaben zum Mitteilungspflichtigen
Name: Registrierter Sitz und Staat:
Global Bio and Information Technologies Partners GP Ltd. George Town, Grand Cayman
Kaimaninseln
4. Namen der Aktionäre
mit 3% oder mehr Stimmrechten, wenn abweichend von 3.
BioChain Institute, Inc.
5. Datum der Schwellenberührung
19.09.2016
6. Gesamtstimmrechtsanteile
Anteil Stimmrechte
(Summe 7.a.) Anteil Instrumente
(Summe 7.b.1.+ 7.b.2.) Summe Anteile
(Summe 7.a. + 7.b.) Gesamtzahl Stimmrechte des Emittenten
neu 9,28 % 0 % 9,28 % 20544009
letzte Mitteilung 5,97 % 0 % 5,97 % /
7. Einzelheiten zu den Stimmrechtsbeständen
a. Stimmrechte (§§ 21, 22 WpHG)
ISIN absolut in %
direkt
(§ 21 WpHG) zugerechnet
(§ 22 WpHG) direkt
(§ 21 WpHG) zugerechnet
(§ 22 WpHG)
DE000A11QW50 0 1905685 0 % 9,28 %
Summe 1905685 9,28 %
b.1. Instrumente i.S.d. § 25 Abs. 1 Nr. 1 WpHG
Art des Instruments Fälligkeit / Verfall Ausübungszeitraum / Laufzeit Stimmrechte absolut Stimmrechte in %
%§
Summe %
b.2. Instrumente i.S.d. § 25 Abs. 1 Nr. 2 WpHG
Art des Instruments Fälligkeit / Verfall Ausübungszeitraum / Laufzeit Barausgleich oder physische Abwicklung Stimmrechte absolut Stimmrechte in %
%§
Summe %
8. Informationen in Bezug auf den Mitteilungspflichtigen
Mitteilungspflichtiger (3.) wird weder beherrscht noch beherrscht Mitteilungspflichtiger andere Unternehmen mit melderelevanten Stimmrechten des Emittenten (1.).
X Vollständige Kette der Tochterunternehmen beginnend mit der obersten beherrschenden Person oder dem oberstem beherrschenden Unternehmen:
Unternehmen Stimmrechte in %, wenn 3% oder höher Instrumente in %, wenn 5% oder höher Summe in %, wenn 5% oder höher
Global Bio Information Technologies Partners GP Ltd. % % %
Global Bio and Information Technologies Partners L.P. % % %
Team Curis Group % % %
Biochain (BVI) Holdings, Ltd. % % %
BioChain Institute, Inc. 9,28 % 0 % 9,28 %
Global Bio Information Technologies Partners GP Ltd. % % %
Global Bio and Information Technologies Partners L.P. % % %
Team Curis Group % % %
Biochain (BVI) Holdings, Ltd. % % %
Bio-Epi (BVI) Holdings Ltd. 3,85 % % %
9. Bei Vollmacht gemäß § 22 Abs. 3 WpHG
(nur möglich bei einer Zurechnung nach § 22 Abs. 1 Satz 1 Nr. 6 WpHG)
Datum der Hauptversammlung:
Gesamtstimmrechtsanteil nach der Hauptversammlung: % (entspricht Stimmrechten)
10. Sonstige Erläuterungen:
Schaden kann das dem Kurs nicht, es herrscht jetzt Klarheit, das Biochain im Rahmen der Kapitalerhöhung keine Aktien veräussert hat ...
am 19.09. hat BioChain ihren Konzern umstrukturiert und die Anteile in einen anderen Unternehmensbereich geschoben. Deshalb die Schwellenberührung.
Salerno kämpft in unserem Lager mit ;-)
User Glib
What you quoted is only part of what the article said. Yes, as I had stated, the serious complication rate requiring hospitialization is only 1.6% *for the first week* after colonoscopy. Which, by the way, is almost 6x what you quoted at 2.8/1,000 or 0.28%.
The article goes on to say:
"... colonoscopy adverse events occur within 7 days, but even more occur beyond the 7-day period. In a mid-2014 handout, the agency said: "Hospital visit rates after outpatient colonoscopy range from 0.8 to 1.0 percent at 7-14 days." And in its rule establishing ASC-12 as a reporting requirement, it estimated the range of hospital visits is between "2.4 to 3.8% at 30 days post procedure."
But Drye noted also that the risk is even higher on a per-person basis, because one must consider that patients who undergo colonoscopies at recommended intervals -- every 10 years, or every 5 years if polyps are found -- would have from three to six colonoscopies before age 76.
Additionally, the measure also only captures the risk for healthier patients; Those with conditions such as diverticulitis or inflammatory bowel disease, and those with serious chronic illnesses are more likely to experience complications from colonoscopy were excluded from this measure's denominator."
So expanding the range to 30 days it is 2.4% to 3.8% or 10 times what you quoted. Then that gets multiplied by the number of lifetime colonoscopies, which with Epi Pro would average two every 10 years, the highest by far of any testing method.
(No doctor is going to tell a patient not to have another colonoscopy if they just had a positive Epi Pro test. It doesn't matter if they'd just had a colonoscopy 3, 4 or 5 years earlier. The liability for not recommending colonoscopy after a positive screening test would be huge. There's no "rule" that you can only have one colonoscopy every 10 years, certainly not if another test has indicated you have colon cancer.)
There's one condition on Epi's use that isn't the same as Cologuard that is that the patient has turned down all other types of testing for colon cancer, because Epi ProColon is the test that has the highest burden of complications paired with one of the poorest detection rates of all other test possibilities.
User Salerno
Glib - You are contradicting yourself. First you said "no doctor is going to tell a patient not to have another colonscopy if they just had a positive Epi pro test". It is not "ANOTHER" it is the "FIRST" in his life time as you acknowledged later that the condition to make Epi test is that the patient has "turned down all other types of testing". So if Epi is positive and colonscopy is negative the best thing to do is to make another colonscopy after 10 years like in the guidelines. You are not going to do another EPI, neither another colonoscopy.
HAL2016
Glib, I would like to stick to academic sources and studies. The article is fine but a longterm study is even better to rely on.
I think this is the specialist in colonoscopy we have to refer to:
Rutter CM, J. E. (2012). Adverse events after screening and follow-up colonoscopy. Cancer Causes Control, 289-96.
And this was the also the source for FDA approval.
Rutter says that in 0.68% of the false positives adverse events may occur. So if you have a population of 100,000 tested with ProColon producing 20,000 false positives, than you have 136 adverse cases. Still a very very low number. And adverse events means not necessarily the death of the patient. Sorry, shall not sound feelingless but that is statistics. How many adverse events may occur while having a wisdom tooth resected (i.e. septic)? I don't know. But there it also can happen.
One of the questions during FDA approval process for Epi ProColon was: In patients who meet the criteria specified in the proposed intended use, do the benefits outweigh the risks for use of Epi proColon?
This was also addressed to your adverse events.
As we all know Epi ProColon was finally approved at April 13, 2016 for sales in the U.S.
Epi is getting CPT1 in October and in Q3 of this year we will see the sales numbers so far. Than we will see how good the test is accepted among the unwilling for CRC screening. But I am sure that Polymedco (selling 10 mln. FIT test per year) and Labcorp are going to make a very good job.
User Salerno
Glib quoted his study in a misleading way and Medscape is just a divulgative source. Both studies are correct, but you have to understand them. The study quoted by Glib is considering ALL unplanned visit to the hospital, including patients that do not have any real problem a part of some pain or minor bleeding. Among the 1.6% of the hospitalized patients only few have serious problems, 0.04% have perforation and 0.08% serious bleeding. Understand please the difference between perforation and laceration.
NEW |
Denke immer noch das wir nochmal die 4,50 sehen bevor es hoch geht.
Jetzt Schlaftabletten und in 5 Jahren aufwachen nach Kostolany. Ich denke, wenn Epi das angpeilte Ziel erreicht, nämlich Marktführer in der blutbasierten Krebsdiagnostik und Forschung weltweit zu werden, ja dann...
Allerdings gibt es bis dahin auch ein hohes Risiko für eine Übernahme. Steht auch drin.
http://www.mastertraders.de/trading/kursziele/...-krebstest-forciert/