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Biobonic

02/03/21 10:14 AM

#35472 RE: lightrock #35471

And one of the cool mathematical aspects of the trial

is the required number of evaluable patients. = 784

which divided by 7 is exactly 112.

The two comparative arms need a minimum of 336 to reach statistical significance.

Original design: total enrollment was pegged at 880 to allow for dropouts.

Adhering to that enrollment (880), the total enrollees in each of the two comparative arms was scheduled to be: 377

These trial arms will have about 377 patients each. The third arm of the trial will have about 125 patients.


Laidlaw report 2013.

The trial design was 298 events in the two comparative arms.

The actual enrollment was an additional 40 total in the two comparative arms...and NO CHANGE to the concluding event number of 298.

With 40 additional enrollees the 298th event should have been reached sooner than original trial design.

Yet it still went on two years past historic OS rates.



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sab63090

02/03/21 10:18 AM

#35473 RE: lightrock #35471

@lightrock

Thanks for the explanation, seems quite complex to me on how this works...but hopefully someone will acknowledge that this presentation was very old (5 years ago) and needs to be "updated".

I am skating on thin ice, so help is needed! Glad that I stepped away from shares between 25 or so......my remaining shares, albeit smaller by 50% from my original shares with an average cost basis of $13.20 makes me breathe a little easier.

I really think Geert is sincere, but damn if I can figure out what he is up to!!! Also, the timeline continues to be STRETCHED out in time, month after month. I originally thought March of 2020....it's now almost 1 year later...this road seems like walking on broken glass with bare feet....

:)