Re: The waiting game.....
in response to
by
posted on
Feb 13, 2019 09:20AM
"Yes, I understood that to be the case as has been talked about here. They did not list the January 2019 presentation on the Investor's page so I missed it."
The January Biotech Showcase presentation was up on their website up until yesterday. But you can magically still access it here.
"What is the upside of continuing dosing patients for such length in time when as has been mentioned that events generally happen at the front end of the trial? Or am I wrong?"
Even though the risk of first MACE event is highest in the front end, that doesn't mean that events don't still happen later on at a lower rate. This dosing adjustment allows for a faster accumulation of patient years. It also importantly allows for a much better safety record to show that there are no surprises that pop up with extended dosing. As I mentioned before, patient dropouts happen. It won't be surprising if 25% of total patients have dropped out at some point in the trial. It is also possible that there will be an imbalance in the drop outs with more happening in the apabetalone than placebo group. So by extending dosing of all patients they can somewhat compensate for the patient drop outs. In hindsight, they should have enrolled more patients to begin with. Plus they decided not to do the sample size re-estimation analysis. But those ships have sailed. In the absence of increasing enrollment at this point, extending dosing is really the only way to increase the rate of patient year accumulation and rate of event occurrence.
BearDownAZ