GREAT WORK…
NO…
REALLY GREAT WORK…!!!
I was waiting for the enrollment complete announcement before I updated my projections again but when I read your post this morning I reviewed my data and…
Well first, to your question of…
“Now, I am unclear on how many events will be needed for the 1st Lookin. I for one would appreciate some clear insight on this matter from any knowledgeable poster.
So I drew two possible cases:
a.166 events for 1st Lookin
b.200 events for 1st Lookin”
Nobody knows the number for “the predetermined number of events” for the look-ins. A while back there was a discussion on this board about that subject. One thing for sure is that it will not be a percentage of total enrollment (582) but most likely a percentage of total enrollment i.e. 80% or some fixed number like 500. For the sake of simplicity and totally arbitrarily I chose those numbers. 80% X 582 = 465.6 = 466 and 500.
I as well, modeled different cases of projected MOS numbers. You selected:
CASE1: BAVI 13 Months MOS. Placebo 9.9 MOS (13:9.9)
CASE2: BAVI 15 Months MOS. Placebo 9.9 MOS (15:9.9)
CASE3: BAVI 17 Months MOS. Placebo 9.9 MOS (17:9.9)
One of my cases; as it turns out is:
CUMULATED NUMBER OF EVENTS TOTAL (15:10)
Hmmmm…
So now we have two different people with two different approaches and a single comparison point…
What do we get?
Using the numbers above of 154 and 165 for numbers of events for first look-in and comparing them in your chart for case #2, it appears that the intercept points are, respectively…
Your projections:
466 EVENTS 33% = 154 early to mid February
500 EVENTS 33% = 165 early March
My projection:
466 EVENTS 33% = 154 late January
500 EVENTS 33% = 165 early to mid February
Our projections differ by only a few weeks and not having the right side boundary of enrollment set yet; I think that that is very confirming.
It also falls in line with SK’s comments in the last C.C. of early 2016 for first look-in vs. first half of 2016 in the previous C.C.
NOTE TO ALL READERS…
The above should NOT be used as investment advice…In previous posts I have labeled my projections as an exercise in mental_masturbation and written for my own amusement.
Moving on…
The bavituximab/Yervoy trial status. Prior to the C.C. I had hoped for a presentation at either NYAS or ASCO in 2016. I don’t think that that is going to happen. Recruitment was painfully slow and it appears that we did not achieve full enrollment. It addition, during the past two years since this trial started the SOC has changed. I hope, at the minimum they can garner enough information to demonstrate that Bavituximab can improve the performance of Yervoy and not add to the toxicity.
To me the most important event was the arrival of a much more pro-active and supportive collaborator AZ. In my view it allows SK to say to BMY…We don’t see the need for us to continue testing Yervoy at this time. The PD-1 and PD-L1 products that are entering the market are presenting to us a far greater opportunity for future growth.
Sniff…Sniff…
I smell something cooking…
Regards and thank you again tradero
golfho
