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biopharm

08/06/16 4:05 PM

#269727 RE: vinmantoo #269725

Right, CP, right. It is now about 6 months after Sunrise was stopped at the first futility look-in and the same time frame since PPHM made the vague claims about both the control arm and the Bavi + DOC arm.



I would say we must wait for the study to be completed, not yet.
This study is ongoing, but not recruiting participants.
https://clinicaltrials.gov/ct2/show/NCT01999673?term=sunrise&rank=1

You have to ask yourself why didn't PPHM provide the numbers then that supposedly supported that vague comment at the tie it was first issued. There is no reason I can think of except is was a desperate attempt at spin in the face of an overwhelming failure. You also have to ask yourself if that vague claim was valid, why hasn't PPHM make it more forcefully and repeatedly now, and why they haven't provided the numbers now.



The answer is biotechs don't reveal all the numbers and that is common sense across the board. For example... BMS just announced that Opdivo failed and also didn't publish full study results. Now we have a silver lining with Peregrine Pharmaceuticals, because they told us the Bavituximab arm performed as expected.... vs no silver lining with BMS Opdivo which actually just failed completely.

Bristol-Myers' Opdivo fails lung cancer trial; shares plunge

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"This is the worst-case scenario" for Opdivo and Bristol-Myers, Leerink analyst Seamus Fernandez said in a research note. "There appears to be no silver lining."
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"Obviously the results of this trial are disappointing," Bristol-Myers Chief Executive Giovanni Caforio said in an interview, saying that the data suggests there is no role in the foreseeable future for Opdivo as a standalone medicine for previously untreated lung cancer.
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http://www.reuters.com/article/us-bristol-myers-study-idUSKCN10G1GA



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Bristol’s study, dubbed “Checkmate 026,” included 541 patients with advanced non-small cell lung cancer with no prior drug treatment. Some patients received Opdivo while others received chemotherapy.

The main goal was to demonstrate that Opdivo delayed disease progression or death compared with chemotherapy. Opdivo missed that goal, Bristol-Myers said Friday in a news release. The company hasn’t published the full results from the trial.
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http://www.wsj.com/articles/bristol-myers-opdivo-failed-to-meet-endpoint-in-key-lung-cancer-study-1470400926

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itsabouttime

08/07/16 9:53 AM

#269747 RE: vinmantoo #269725

Certainly by this next quarter their should be some follow up
information regarding SUNRISE data as related to their observations
of control arm out performance and bavi performing as expected.

Otherwise what would be the point of even making the statement unless their was an intention to provide future data results to shareholders?

If control control arm out performed historical norms and bavi performed as expected is all we have with no further follow up statements to explain this, then I have an issue with SK.

When you make these statements at the CC to the share holders you
(in my opinion) owe them an explanation as the data analysis is completed.