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04/08/16 7:25 AM

#261165 RE: jq1234 #261163

jq1234 that is because you left out ONE of the TWO possible hypothesis.

The first one is the one you mentioned and if the Early Stop would be based on NORMAL control arm performance then 3 different people, with 3 different calculation approaches came to the same FORK of results and posted them, I was one of them.

ALL 3 have said that the ONLY OTHER explanation would be a BIG OUT-PERFORMANCE of the control arm. You picked a reply post in which that part is not again mentioned. I wrote it, by memory, in at least 3 posts.

Now if you would have said that we did NOT EXPECT that second hypothesis to be possible because it would need an unseen performance of the control arm above Herbst et al, 2010 (which was 9.9 months) then you would have been correct. I think very few on here expected an anomaly in the control arm.
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vinmantoo

04/08/16 11:38 AM

#261217 RE: jq1234 #261163

jq1234, Did he really post the following with a straight face?

{{Yea right, just like the "safe" assumption about 1st look-in:

138 CTRL ARM events
16 BAVI ARM events }}


In the history of oncology trials has there ever been such a skewed distribution in favor of a drug arm at first look, or at any look for that matter? That is 90% of the events in the control arm. How in the world could anyone expect that? Just wow!
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JamesGMS

04/08/16 1:28 PM

#261233 RE: jq1234 #261163

jq, re your post below:

>> 12.1+4.8=16.9 months POTENTIAL for Bavituximab, So 14 MONTHS expectation for the Bavituximab arm in SUNRISE is a quite safe expectation.


Yea right, just like the "safe" assumption about 1st look-in:

138 CTRL ARM events
16 BAVI ARM events

investorshub.advfn.com/boards/read_msg.aspx?message_id=120462194

Called it BS then, call it BS now!



Just one opinion - but it seems you are loosing the argument - the prior post you reference was not "BS" at the time - and I think three respected posters had mostly agreed with the possibility of such a result in their respective simulations - what you need to keep in mind is that their simulations were assuming that the control arm would perform up to its "best" historical norms {I think they all assumed a 10 month MOS} - and if that had indeed been the case, then the numbers above would have been the only way such a result could be explained - particularly in light of the 9.4 month MOS the recently completed Opdivo trial had demonstrated for Doxe. So NO ONE had any idea that our Control Arm would so DRAMATICALLY OUTPERFORM its historical record.

Also, keep in mind the 9.4 month MOS in the Opdivo trial - If our control arm would have simply performed at this same level {which I would note is still on the high side of its historical average going back over 15 years}, then we would have seen a much earlier first look-in {which could have brought about a halt for efficacy} - but most likely Dr. Garnick would have waited for the second look-in {which likely would have taken place a month or so ago} and then the trial would have been halted and we would be waiting on final approval right now.

Finally, while I of course do not know why - but it deserves repeating - I've been told that Dr. Garnick's mood has only recently improved quite dramatically. I would hope we will find out why sometime soon.

Enjoy your Friday.

James