Avid Bioservices Inc (CDMO)

[tradero]

I think there are good reasons to be optmistic.

Thanks EX for your reply.

The trial can not be stat sig at the first look as there is no alpha assigned (if we believe SK). So one can not possibly assign a percent chance of being stopped for such.

I agree that the 1st look-in may not be stat. significant.
However, we have good news in front of our veryy eyes IMHO.
Since you talk about numbers, let me repeat what may have been lost in the too many words I used in my last unreadable post.
Just from the info we have right now, we can have big hopes that Sunrise trial is doing great.

Let’s see:
1. Do you agree that the Placebo Arm in Sunrise will behave pretty much like the Herbst's Trial (Doce + Placebo)? We should bear in mind that the patient population and number of patients are very similar in both trials.

2. Do you also agree that the enrolment model based on the dates when Sunrise Centers joined the trial can give a “fair” enough enrolment curve? Well, I know this is debatable but I don’t think that reality differs much from this:

A hockey-stick type of curve and on the conservative side regarding enrolment, and let’s remember we are playing conservative for enrolment (and therefore for the eventing part).

With these two assumptions in mind and some simple math, I believe we can estimate the number of events that may have taken place for the Placebo Arm at a particular moment. We may be guessing the statistical results for Bavi, but we do have stats. results from the Placebo Arm.
And what I tried to show in that post is that by the end of this month the numbers say 119 events, and 130 events by the end of March, both for the Placebo Arm.

Even if the model I used may not be too accurate, I certainly think that there are already more than 100 events for the Placebo Arm (if it behaves like the Placebo Arm in the Herbst' trial)

If 1st look-in has not happened yet (fact, LOL)… In my opinion this means that the events coming from the Bavi Side are not half of the numbers from the Placebo Arm (around 150 events needed for 1st look-in?).

For me this a good reason to have high hopes for the Sunrise trials.