Replies to post #224960 on Biotech Values

[iwfal]

FGEN -

So people want the P values for each pool wrt MACE that AZN release doesn't provide.

FGEN release does put bounds on P via confidence limits.

DD pool p >0.05
ID pool P < 0.05 (implied)
NDD pool p >0.05

This is simple. For Non-Inferiority trials investors want to know:

a) Meet NI or not

b) Superior or not.

c) If only NI, what was your trend? Above 1 or below 1?

And they had 3 or 4 groups (ND, ID, SD and DD (which is an aggregation of the previous 2))





for #a above the answer was ugly for all groups' MACE, although at the end of the cc Peone said 'if MACE NI boundary was 1.3 in NDD, then we met it'. But it had to be dragged out at the end of a 1:30 cc, and we still have no idea about the other groups meeting MACE NI.

For #c above the answer was generally pretty unclear. I think for DD overall they said under 1, but SD could still be substantially above 1. And for ND I think the numerical is above 1 - but they appeared to be dancing on this so hard to tell.

And for #b, they were superior for MACE+ but not for MACE - and this requires explanation, which was not given. (I suspect this is primarily an artifact of fewer events in MACE, but I shouldn't have to guess.)

So, again, I grant that it was a complicated set of results - but they seemed very ill-prepared to discuss those complexities. My guess is that they trend worse on MACE/MACE+ for both SD and ND.

But, having said that, the ID result (MACE+ superiority) and, potentially, the NDD result (better QOL, better GFR and (from previous releases) fewer transfusions) means it is likely to still be a reasonably big drug. (So all the more reason to just clarify, not dance around the data).