Biotech Values

[mcbio]

FGEN -

The above quote-within-a-quote (red text), implies that when they had *around* 150 man-years in NDD and 100 man-years in DD, the DSMB saw something compelling. But now, with >50x more data, we know it couldn't have been an aggregate benefit of MACE/OS, or, if it was, it has since proven very ephemeral (because if it had repeated the trials would be massively stat sig - and there is no way that the trial would be allowed to continue).

Always fun for me to re-visit that quote as it's one of the main reasons I took the plunge in FGEN. I guess the obvious question for me is, regardless of efficacy, how do you know the trial could have been stopped? We don't know any specific stopping criteria, or even if any exist, right? Also, you are looking at cumulative years across entire patient population; could it be possible even given specific stopping criteria, that there is clear efficacy but simply not long enough duration in enough individual patients (i.e. man-years adds up quickly given enough patients even if on treatment shorter time but still may not be long enough duration in large number of individual patients)?

My *guesses* (because this is interesting) are:

a) Benefit to eGFR - the effect seen and published in the AKBA trial is more than strong enough to show up massively in even 150 man-years.

b) Odd distribution of MACE and/or OS - i.e. early spike, later return to baseline rate in SOC (or below)?

c) Benefit in MACE, but not OS?

What are your thoughts on possible stock reaction in each of those scenarios?