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Message: Take Home Points: not ready for use in patients

 Thanks for the link to the slides - first time I have seen them.

The results are very promising, but it's a pity the study was underpowered and too short.

I think the last line of Dr Ray's last slide will be very influential on the FDA. If the PI says something like that, I think they are unlikely to go against it.There's just a chance, I would guess, of approval for the low GFR patients, but the FDA will want to see how well the two groups were matched for the important variables.

The fact that the numbers of normal and low GFR patients were so different seems to indicate they were not stratified on the basis of GFR before randomisation to drug or placebo, which is a pity.

As several on the board have said, RVX now needs a BP partner to take apabetalone to the finishing line, but I can't imagine they'll have difficulty finding one among the several big companies with interests in diabetes-CKD-CVD. Let's hope there's some healthy competition!

 

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