New Venturetec

Ne,

http://www.google.com/finance?q=NASDAQ:OSIR

Nadann warte ich doch mal auf die 4 beim rebuy

beschissen??

im netz taucht die frage auf ob Osiris beschissen hat mit den daten

jetzt gehts dafür aber runter

jemand billig einsteigen???

und schon steigt der Kurs wieder.

lotus-elan

beschissen??

im netz taucht die frage auf ob Osiris beschissen hat mit den daten

hast du ein Link wenn du solche aussagen machst?

wie gehts denn hier mittelfristig weiter? denkt ihr wir werden die 6 und 7 schon bald wieder sehen oder nur bei News?

http://www.thestreet.com/story…sults.html?cm_ven=GOOGLEN

Ausschnitt:

Naturally, Osiris didn't come out and tell investors that it was issuing a misleading press release on the Prochymal heart attack study. Instead, the company claimed the study was a success. That's not true.

schau mal hier

Company Fibs About Clinical Trial Results

By Adam Feuerstein [Blocked Image: http://i.thestreet-static.com/files/tsc/v2008/css/images/email_9x12.gif] [Blocked Image: http://i.thestreet-static.com/files/tsc/v2008/css/images/print_14x13.gif] [Blocked Image: http://i.thestreet-static.com/files/tsc/v2008/css/images/reprints_12x13.gif] [Blocked Image: http://i.thestreet-static.com/files/tsc/v2008/css/images/feed_icon_12x12.gif] 07/03/12 - 07:52 AM EDT

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Stock quotes in this article:OSIR

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[Blocked Image: http://i.thestreet-static.com/files/tsc/v2008/css/images/tryCramers_aap.gif]

COLUMBIA, Md. (TheStreet) -- Osiris Therapeutics(OSIR) "disappeared" important data when the company announced results Monday from a mid-stage study of its stem cell therapy Prochymal in heart attack patients.

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Naturally, Osiris didn't come out and tell investors that it was issuing a misleading press release on the Prochymal heart attack study. Instead, the company claimed the study was a success. That's not true. Figuring out Osiris' deception wasn't that difficult if you know how to parse the language of clinical trial results and look at independent sources of information for the truth.

Ride along with me as I pick apart Osiris' statements regarding the Prochymal heart attack study. Interpreting clinical trial results with a skeptical eye is a crucial tool for all biotech investors, so apply these skills universally whenever a drug or biotech company tries to convince you that its drug works. Hopefully, you'll find most companies are telling the truth, but sadly and too often, bullish pronouncements about boffo clinical trial data are just spin jobs ginned up to plaster over problems and bad data.

Here's what Osiris issued Monday:

Osiris Therapeutics, Inc. announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack.

Not much to quibble with here except it's helpful to know that Osiris enrolled the first heart attack patient to this study in April 2009, so it took more than three years to complete and report "interim" results. ClinicalTrials.gov [a great, independent source of clinical trial information, by the way] lists the completion date for this study as December 2011, so Osiris appears to be reporting results six or seven months late.

Osiris:

Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling.

Cardiac MRI is a precise and commonly used method of measuring cardiac changes in clinical trials. MRI assessments were conducted for six months after heart attack patients were enrolled and treated with either Prochymal or a placebo, but Osiris purports to be reporting interim, one-year results. When were the MRIs conducted in the Prochymal trial? Osiris doesn't specify, which clouds the reported results, especially if MRIs were not conducted at 12 months follow up.

Osiris:

Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p [less than] 0.05). Patients treated with Prochymal also experienced significantly less stress-induced ventricular arrhythmia (p [less than] 0.05). Cardiac hypertrophy and ventricular arrhythmia are indicators of pathological remodeling following heart injury and provide insight into the mechanism by which mesenchymal stem cells attenuate heart injury following a myocardial infarction.

This is the paragraph where Osiris claims positive results based on Prochymal beating placebo across two efficacy endpoints. Sounds impressive except none of the Prochymal benefits disclosed by Osiris are predefined endpoints in the phase II trial.

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ht-ing hat am 03.07.2012 - 15:41 folgendes geschrieben:

Quote

http://www.thestreet.com/story/11605008/1/how-to-tell-when-a-drug-compan...

Ausschnitt:

Naturally, Osiris didn't come out and tell investors that it was issuing a misleading press release on the Prochymal heart attack study. Instead, the company claimed the study was a success. That's not true.

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Ausschnitt:



Natürlich wurde Osiris nicht herauskommen und sagen, dass es Investoren wurde die Erteilung einer irreführenden Pressemitteilung über die Prochymal Herzinfarkt-Studie. Stattdessen machte das Unternehmen die Studie war ein Erfolg. Das ist nicht wahr.

Wollen wir mal nicht hoffen dass das stimmt - ansonsten kann ich mir gleich ganz günstig welche kaufen - frag mich zwar ob ich dass dann überhaupt noch will...

hier ein weiterer Ausschnitt:

Osiris appears to have thrown out the real endpoints called for in the phase II trial and replaced them with new endpoints which just happen to show Prochymal in the best light. Why would Osiris do this? Perhaps the pre-defined endpoints in the study all failed? That's a pretty safe assumption when companies decide to swap out trial endpoints with no disclosure or explanation.

wenn die Studie kein Erfolg war, wieso kann dann die Zulassung in 2 Länder bereits erfolgt sein? Und wir sprechen hier von Länder die ein gutes Gesundheitswesen haben

Also im Wesentlichen sagt der Artikel die Phase II Studie ist fehlgeschlagen, mit den vordefinierten Zielen...

und Osiris hat das einfach unter den Tisch gewischt und aufgezeigt wie andere Sachen positiv rauskamen und stellt das so hin als ob damit ihre Ziele erfüllt...

vielleicht will jemand nur günstig einsteigen??

lotus-elan hat am 03.07.2012 - 15:48 folgendes geschrieben:

Quote

vielleicht will jemand nur günstig einsteigen??

Ja Pirelli :cool:

fat-finger-trade hat am 03.07.2012 - 15:46 folgendes geschrieben:

Quote

wenn die Studie kein Erfolg war, wieso kann dann die Zulassung in 2 Länder bereits erfolgt sein? Und wir sprechen hier von Länder die ein gutes Gesundheitswesen haben

die Zulassung ist nicht für den Blockbuster Bereich (herzinfarkte) sondern für nischensachen (GvHD).

denke der Kurs wird noch viel mehr reagieren als bisher... -20% mein Tipp... OSIRIS

Jetzt sind wir bereits auf 10 unten. Ich bin momentan etwas skeptisch. Bin schon beim Anstieg zu spät rein (7.-) und hab dann verpasst rechtzeitig rauszugehen. Was meint ihr, Schadensbegrenzung oder stehen die Chancen gut, das New Venturetec respektive Osiris noch einmal kommt?

Das wird mir zu heiss. Ich bin raus.