Replies to post #260882 on Avid Bioservices Inc (CDMO)

[Protector]

jbainseky, the exact language was posted here past week or the week before if my memory is good. I don't have search facility on here. It was ALSO in a CC and a reply to a question from an analyst.

Shan (transcript CC):

Secondly, when we powered the study, in the Ph2 study we saw about a 4mos. difference in median OS, and the SUNRISE study was designed to really show a statistical difference even at 2mos; we built in some powering assumptions we think will give us some opportunity there should be arms behave in a way that was little bit unexpected. So, we’ve tried to hedge against that going into the stage design and we think we’re in good shape and now it’s just a matter of getting the readouts

Unfortunately it wasn't just a "little bit unexpected" it was "dramatically unexpected" and that is where we have a 'shot' given all I explained in my past posts.

[BCS Paladin]

Moreover, why do you assume they only used those three trials for their design assumptions?

CP's assumptions are as good or better than facts

[Protector]

jbainseky, here it is;

CEO King (Q/CC Q&A transcript) answer to the question of an analyst of WHAT IF the control arm outperforms as seen in other companies trials.

...
Secondly, when we powered the study, in the Ph2 study we saw about a 4mos. difference in median OS, and the SUNRISE study was designed to really show a statistical difference even at 2mos; we built in some powering assumptions we think will give us some opportunity there should be (must be 'the') arms behave in a way that was little bit unexpected. (NOTE: 'unexpected'=should it outperform behind past study expectation) So, we’ve tried to hedge against that (NOTE: 'hedge'=a counter messure, 'that'=outperforming control arms as topic of the question asked) going into the stage design and we think we’re in good shape and now it’s just a matter of getting the readouts - we’re little under 2yrs right now from when we started to study, so at this point there’s really nothing more we can learn from the ongoing operations of the SUNRISE trial itself.

So that is where the margin comes in. Only INCREASING expectations based on the MOS of Doce alone or Doce+placebo of past studies (9.4=Opdivo last year, 9.9=Herbst et all 2010, 10.4 highest ever) can be the counter measure. And increasing the expectations of the control arm BEHIND what the historical study data indicates that is applying a margin.

So in the SUNRISE stage design PPHM hedged against outperforming control arm, in case such control arms would be a little unexpected (not dramatically unexpected as was the case), and they did it by building in some powering assumptions, based on PII 4MOS observation. So thinking Bavituximab could do 4 months, they will have set it to 2 Months for the end points, allowing them to increase the control arm expectation by 2 months and still get approved.

Now the 2 months is NOT exact maths. It might have been 4 or 5 weeks but in any case is tuned to what PPHM expect Bavituximab to be able to beat and which has also be found sufficient by the FDA. And hence if bavi performed as expected that it made a 2 months difference with the control arm DESIGN EXPECTATIONS which where historical+margin and which I GUESS/ASSUME/SPECULATE to be 10.4+1.6=12 months, hence expecting Bavi to do 12+2=14 months and therefore beat the current SOC big time because it is below 10 months.