Avid Bioservices Inc (CDMO)

[jbainseky]

CP, there you go again.

My apologies to the board if anyone feels I used "deception" but I did not "cherry pick" a date because if I had picked May 29th, yes there were 61 sites open, but based on first patient enrolled 4 months after a site opens, there are still only 4 patients enrolled!! I also made it clear that your additional 21 sites make no difference on the number of events at this time because none of those site's patients could have evented by now! Here is the site activation I used for the first 130 sites (for full disclosure), I did add the next 8, but not the rest. Sometime when I have the free time you do, I will add those. However I can assure you, it doesn't make a significant difference. but you could do me a big favor and provide me and the board with the dates of the last 21 sites activated. That would save a lot of time!



everyone can see that in the 4 weeks from late May to mid June, nearly 60 sites were activated, but that enrollment bump doesn't happen until September.

But that aside, you said:

With your parameters 120 days we have 152 Ctrl events and 90 Bavi events.

Used same parameters as this simulation but with 120 (4 months) instead of the 112 days and your 7.6 monts instead of 7Months for the Ctrl arm..

And of course I did it with ALL 159 centres because I don't do halve work.

And you do NOT need me to enlighten you because one of golfho's simulations was a 4 month simulation and your 7.6 vs his 7 months doesn't account for the difference. So if you don't believe me maybe look at his simulation.

I think saving you, as you requested, is no within the possibilities. I could agree with your first sentence by now!

So I am mistaken, I thought you used the parameters I provided (that I used in my model) and you put them in yours and where I claimed there were only approximately 50 events at this time, that you were correcting me and saying under the same conditions, there would be 242.

It wasn't clear to me that that was not what you did. It appears (but I don't know for sure) that you took the parameters but did not constrain your model to the explicit PPHM guidance of attaining full enrollment in December 2015 and trial end in December 2015. This is critical because it is PPHM's plan.

My faulty theory simply states that if you model the PPHM guidance for full enrollment and end of trial, and use a linear (average time to enroll each patient), and use the phase II results, then there are approximately 50 events at this time. I didn't just make up the 4 months to enroll each patient, that is what is needed based on the site activation curve to meet the PPHM guidance of full enrollment in December 2015.

I show the graphic with my model of site activation, enrollment and events. You can clearly see the repeating pattern of site activation in the enrollment and event lines. The separation between the enrollment and events is appropriate at the average between control and investigational drug. Perhaps you could provide such a graphic for your model? I'm fairly certain that if you already have 242 events, and used an average time to enroll patients based on the site activation curve, that you reach full enrollment long before December 2015.