Replies to post #252639 on Avid Bioservices Inc (CDMO)

[north40000]

Did anyone understand the "mix" of this post?

[DrRocker]

CP,
Do you know if the data monitoring committee shares specifics around number of events per arm with Peregrine after the first look in or do they just give their go ahead to continue the trial assuming no safety issues or futility? If the former, then it could be interesting to watch for management's confidence level after the first look in is PRed.

[tradero]

Thanks CP for your thoughts.

Just a few comments to your post. You talk about 582 enrolled patients but I don’t think that there are that many, something like 542 (582 x 0.9) plus only. Around 560 at most? But I don’t think that this really matters right now.

The following may have nothing to do with your post, but I would like to make a comment regarding the enrollment curve and how close our projections would be to reality. If it is a “hockeystick” type of curve and (thinking of the chart), we do know the starting point of the curve, we do know its end point (560 after that many months) and the type of curve it is… the error from assuming an enrolment curve (based on the starting date of the Centers involved) should be quite acceptable. I know this has nothing to do with your comments but just saying :-)

7) As explained here we need 173 events for the 1st look-in. And since 173-92=81 there would be 81 more events needed for the first look-in.

I would have thought that from different opinions expressed here it was understood that for the 1st look-in we would need something around 150 events the most. I think "173" there may be way too many. You are taking 582 x 0.9 x 0.33 = 173, but I am not sure it will be like that (please see exwannabe #252610). If we take into account “droppedouts” It would take too long to reach that number. 1st look-in (and 2nd for that matter) would be unreasonably long and not fair for the trial… Projections would send first look-in into the summer, while SK expected them to be 2016Q1… Mind you, though projections may not be very accurate (agreed)… but they sure can give you an order of magnitude… and 173 events for the 1st look-in would not happen in Q1 unless Bavi Arm is doing not so good.

And we believe that is not the case