It might be a little bit more complicated than what you think...

It might be a little bit more complicated than what you think ammie.

Remember this trial started on the drawing board as a P2/3 trial. I took this to mean it comprised exploratory elements (dosage, timing, patient selection) which would then trip over into the confirmatory P3 stage.

But by the time it left the drawing board the trial was P3.

What this meant as a P3 trial was that you ran the gauntlet of the trial being stopped early for futility - short of the recruitment target. Which is what happened - simply because the primary outcome was unlikely to be met.

But from an exploratory perspective the more data the better. And so the flip side to advantages the P3 trial is that there is no / little consideration to exploratory aims.

In practice there wouldn’t have been a Statistical Analysis Plan developed for Plan B – trial stopped early.

And the best approach to deriving exploratory efficacy signals from this database in a rigorous manner that convinces a big pharma partner is not straightforward and need to be developed from scratch.

So its not surprising to me that this is going to take a little time. Because the value to anyone of a efficacy generated from this database is going to depend much more on the rigor of the process through which it was generated than any biologically based fairy story based on a confession from a tortured database.

Meanwhile its fascinating to follow the career path MSBs previous Head of Immunology Development which seems to be taking some unusual twists and turns in this topsy curvy covid clinical trial space.

https://www.fiercebiotech.com/biote...er-rahman-quietly-exits-amid-leronlimab-limbo