Replies to post #251071 on Avid Bioservices Inc (CDMO)

[biopharm]

1/3 of 80% =155

Great post tradero and very helpful. I am still surprised to hear about the 1/3 of 80% vs 1/3 of 100% and I was not sure if that is typical of other trial designs or maybe Peregrine was able to leverage this into Sunrise. I am becoming very intrigued on trial designs and I think "biomarkers" will be included in Peregrines list of surprises. Very interesting times ahead....

[eb0783]

Thanks for the great update, tradero! You and golfho, and the others put in a lot of hard work making and updating these estimates. Thanks to you all!!!

[itsabouttime]

Excellent tradero very instructive charts for us investors to mull over.

Plus thanks to the other contributors Mojojojo & GOLFO.

[Protector]

tradero, nice update. The 80% from RRDog's post was something I missed from CEO King's presentation, but finally we do have a basis for that 33% and 50% of events.

Thanks for the huge effort and well documented post.

[exwannabe]

Re: numbers and predictions.

Though I think GolfHo's method should work reasonably well, there looks to be a mechanical error when he gathers the table describing an event rate based a similar trial, then adjusting for median.

Look at all the 20 month survival values. On the pattern trial GH uses, the 20month survival is about 30%, yet GH's is 4% for the placebo arm. These numbers do have slightly different meanings due to drop outs, but that effect will be minimal.

Perhaps you or GH could dig up the post where he has his final calculation of this table so we could discuss it?

With the enrolment curve reasonably well known (still some wiggle room between "fast" and "slow" ramping, but not much). And with the event targets known, it is possible to get reasonable estimates on when the 1st look happens for various MOS guesses.

FWIW, my estimates for SUNRISE with various successful (3 month MOS advantage) curves has IA-1 around late spring - early summer. I used enrolment ramping somewhat faster than GH's and events based on constant hazard model. Not trying to say this is "right" as there is still variation possible.

P.S: This estimation game is fun, but often ends up not being very accurate for many reasons. Will the curves have late separation (which is good, but not show up much this early). Could PD-L1 expression testing results effect trial selection (and who knows what that would actually mean). ...

So nobody should put much faith in any of this (and that certainly includes my post here).

[masshysteria]

Thanks much for an excellent update and continuing to put effort into this simulation tradero.

Having this type of analysis makes it easier to connect assumptions, hypothesis and disparate data points into a clearer picture and develop reasonable understanding of how the milestones we're waiting for relate and come together.

Thanks again to you, golfho (who certainly lives up to his name) and Mojojo for simplifying the complex.

Best,

MH