Replies to post #243060 on Avid Bioservices Inc (CDMO)

[Protector]

DewD, yes I wrote 67% in another post. I may have expressed this wrong. Let me retry.

The first and second look-in are event driven 33% and 50% but with NO exact date but rather a larger range (H1/2016 for 1st look-in and as of H2 for 2nd look-in.

The end of trial on the other end has been assign an END DATE in which PPHM expect the number of end-of-trial-required-events to have taken place (the 67% that I posted earlier was a GUESS because as far as we know that number has never been disclosed for SUNRISE). The end date of DEC/2016 was in the protocol but, certainly in the beginning, must also for PPHM be a roughf but educated estimation of which we know in MANY trials (not specifically PPHM) these dates are often incorrect and adjusted later. We had examples with two other trials from PPHM from which the end dates were moved more in the future a number of months ago.

However, for the DEC/2016 of SUNRISE we receive NEW RECENT (two months now I think) confirmation from CEO King that the SUNRISE trial would be unblinded near year end 2016. And as you may have seen in other posts I give more value to such statement (as with enrolment on-track) the CLOSER they are made towards the date in question. I start from the assumptions that the nearer one gets to such date and confirms it the more risk/unpredictable stuff/deviation from expected progress/etc are out of the equation and allow for better tuned statements, which of course still doesn't make it exact maths.

In the case of SUNRISE CEO King made this last statement of unblinding SUNRISE near year end 2016 while PPHM was within 12-10 weeks from end of enrolment and that clear view on the state of enrolment (that we don't have) must have allowed him to reconfirm unblinding in a, FOR ME AT LEAST, more reliable way.

Hence, but let it then be my personal opinion, I see his statement as a fixation of the end-date of DEC 2016 because he made it at a well informed time. I assume they also used (Herbst et al. 2010) in combination with the ratio between enrolled patients (with 1:1 randomisation) versus eventing. PPHM may receive both types of data (enrolled and evented patients) in a double blinded clinical trial and randomisation, since it is 1:1 can be simulated by a 50/50 on enrolled patients the know the population of both arms.

Hence my statement that we have a date (DEC/2016) for the end of trial (=unblinding), but your comment was certainly correct.