Avid Bioservices Inc (CDMO)

[Protector]

Threes, yes it makes absolute sense.

Let me explain and pls read also the second part of this post.

The Data Monitoring Commission/Committee receives, per PPHM protocol design, a number of guide-lines as to when to STOP the clinical trial for futility.

A Big miss understanding is that futility means failure of the clinical trial. That is not what it means ALTHOUGH in practice often the case. FUTILITY means that that it makes no sense to FURTHER invest into the continuation of the clinical trial (treating MORE patients) as it is expected that such further treatment would bring nothing to the table that might change the outcome of the clinical trial.

It is an ADVICE and the sponsor (PPHM can follow it or not and stop or not stop the clinical trial since they know what the guidelines were).

However, just like an early stop of an clinical trial for efficacy turns sour by times because after looking at the details the results are not what was expected (e.g. by some maturation of the data the effect dissapears because the sponsor has set its parameters to narrow below a point of certainty) a futility advice can the other way around yield statistical significant results in an end-point because the sponsor has set its parameters extremely wide.

However, for the FDA all that does NOT count. They expect statistical significance on efficacy and safety. They couldn't care less that a sponsor has given guide-lines that let the DMC believe that the give guiding end-points can never be reached as long as the protocol end-points are reached.

Importance was that the SUNRISE trial was stopped AFTER Shan told us that the number of required patients for the FDA had been treated. If then guidelines are given that allows PPHM to early exit the trial (AT THEIR RISC) because they know about the tail formation and Bavi latency and know that maturation of the data after the stop (which is allowed) will turn the table, that is OK for the FDA.

Thing is that you, and possibly others, may have been confused because the term FUTILITY has been miss-represented on here as meaning FAILURE.

I have however posted at least 10 times explaining it was not the case and I knew I would have to wait for a PR like today's one (or possible the presentation itself if they would not have PR'ed it) to pull a number of people of that bridge.