Nice thread: Nidan, Xena, Polar. Thanks for the good posts!
Since Missling stated in his Feb update re the status of the trials that the release of the genome biomarkers which will enrich our trials will be released at an upcoming scientific conference (but not before then), but that they will not interfere with...
beginning the trials...!...
is it fair to connect the dots that if we file an IND for AD trial (prior to the conference) and it is accepted, our biomarkers (identified and already in place) are acceptable to the FDA?
Is it also fair to connect the dots that the ph2/3 cohort participants (Missling already has a number for sample size of participants calculated and stated it would be 200, and that they would be from both North America and Australia) that sites are already lined up and waiting for green lights?
Also, since the database is housed in UK and was funded by that government and begun under PM David Cameron, the notion of a greater number of cohort participants having genome sequencing stored in the database being from Australia and Canada (British dominion) may make the task of finding matches for our genetic biomarkers and enrolling participants somewhat easier? A task, I believe M already has mapped out contingent upon FDA granting approval for the IND endpoints and biomarkers. Also, remember, we can change endpoints (if FDA does not approve) and, based upon biomarkers we have access to, gather any cohort we need which will best match whatever endpoints are approved. Not a remarkable claim...a fact. A cohort powered by genetically pooled data informing of matching biomarkers is an amazing resource.
One article I read said random blind placebo controlled drug trials until now have been geared toward a 155lb white male participant with no other complications (age dependent on the indication). And we hear talk of “bias” on this board...that’s bias of the narrowest kind - homogeneous “type” overpopulating one’s trial, then wonder why it fails.
It’s ironic that we spend so much time discussing why a graph axis was labeled one way rather than another and the implications of how this skews the results, but never mention that the entire population is skewed in a cookie cutter fashion - a much bigger, more misleading bias. And indication of ineptitude, imo.
As for the CEO of BIIB, if he led Merck for 20 years as mentioned, ask yourselves why Merck just folded their entire AD program - just 2 years after he left...without advancing the science one iota. Comparing him to Missling is not apples to oranges; it’s apples to “bananas”, imo.
And Biogen lets him head their search for a successful Alzheimer’s treatment. Whoosh?!
His answer to the failing promise of the drug - add more participants. Okay, so if I’m a businessman and I lose $1 on every item I sell, I suppose that suggests that in order to achieve more revenue I need to increase the number of items I sell? Same logic.
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