I think your point is well taken.
I understand that statisticians are more interested in hazard ratios and confidence intervals now than simply judging based on a binary p value. The Forest Plot was impressive.
Is there a real difference between p=0.049 or p=0.060? Very little in fact.
I’m skeptical that the FDA will approve the drug right now but I can’t see how pharmas are not lining up. Don had mentioned there was plenty of interest in the company.
This is an entire new branch of medicine. Big Pharma will not want to be left behind now that safety has been shown and efficacy has nearly been shown.
BETonMACE revealed a safe, biologically active molecule (HDL, Alk Phos) that narrowly missed a 3 point MACE outcome in a sick population in a relatively short study.
Many scientists have been very skeptical of the whole epigenetics field due to safety concerns.
That has been put to rest and now we see a molecule that should be able to be approved in some form in the future.
bfw