posted on
Mar 06, 2019 10:14AM
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Message: Re: What if
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"Long shory short, if we come up short on numbers for this diabetic cardio trial but have success in either or both of these sub studies the RVX story will be far from dead. If they come in with good numbers in all categories even the most aggressive guesses on the share price game could be dramatically low. The secondary studies in BoM represent opportunities that are much much larger than diabetic CVD patients."
Fun with hypotheticals. Keep in mind that even if the CKD and dementia sub-studies give great data, that these are not primary outcomes in BETonMACE. If the primary outcome fails and apabetalone isn't issued an NDA or MMA for cardio, then there would be no opportunity for off-label use for dementia, renal, etc. Apabetalone could not be FDA or EMA approved for renal or dementia without further clinical trials focused on these indications. So it would be great proof of prinicple data suggesting a strong likelihood of future success for renal and dementia. But first Phase 2 and 3 trials would need to be run in these indications prior to approval. More time, more money.
One lingering question I have is whether success in the primary outcome for one of the pre-specified analyses would be enough for approval? In the event that BETonMACE fails to achieve significance for the primary outcome in the total population, could statistical significance with a pre-specified analysis be enough for marketing approval? The obvious one is the rosuvastatin + placebo vs. the rosuvastatin + apabetalone. But there are many other pre-specified comparisons too.
BearDownAZ
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