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FGEN
FGEN - FWIW it should have been at least a little expected that there would be a much larger fraction of patients with really low GFR than in comparator trials with similar entry criteria - because the rate and severity of anemia is a strong function of low GFR. (The surprise for me is that that there are any significant number of patients at, for instance, GFR<=10.)
FGEN
FGEN Prediction: when the full data on Non-Dialysis (ND) MACE/MACE+ is made available, I predict there will be a substantial difference in HR for patients above GFR=15 vs the HR for those with baseline GFR below 15 – with high GFR patients having much better MACE HR than low GFR patients. Why do I predict this? Because:
a) Low GFR patients traditionally have a high rate of adverse events with renally active drugs, regardless of drug class. For instance, the classes of drugs most prescribed for slowing renal failure are ACE/ARB, but they are a concern once the GFR is too low. And PHD Inhibitors are definitely renally active.
b) Fibrogen started talking about ‘GFR decline’ benefits specific to GFR>=15 patients in late February, when previously (Jun last year – see 8k transcript) no such differentiation was made with respect to baseline GFR. It is, of course, possible to interpret the Feb disclosure in other ways – e.g. as a hint as nothing more than benefit in GFR decline did not occur in patients with baseline GFR under 15. But even many of these other interpretations imply some adverse event benefits (e.g. MACE) for GFR>15 patients since declining GFR leads to more adverse events (and once under 15, it would generally be a fast decline in terms of adverse events)
c) A late breaking decision to split ND patients at GFR=15 (presumably driven by looking in detail at some of the previously unblinded, but smaller ND trials) would also substantially explain the complete catastrophe of the early May cc since:
C1) If they did only recently decide to split ND at GFR=15, then they potentially wouldn’t have had time to finish discussions with the regulatory agencies before their planned unblinding of the big MACE trials.
C2) Assuming an unresolved set of discussions with a regulatory agency (i.e. FDA – although it will be interesting to learn why no such issue with EMA) the companies would have to be EXTREMELY reluctant to try to discuss it in public, since regulatory agencies generally look unfavorably on litigating in the court of public opinion.
C3) NOTE: I am assuming that the ITT ND MACE data is not great. Probably meets non-inferiority, but maybe not – either way I’d be surprised if was very good. (If it had some redeeming ITT characteristics I assume they would have said something, however reluctantly, as they did with Stable Dialysis.)
Final note – I am reluctant to speculate on how much clinically better (e.g. does GFR>15 have MACE/MACE+ HRs under, say, 0.9, while GFR<15 is over 1.2? I don’t know.)
Previous predictions related to FGEN:
a) I speculated in 2016 that there were would be a GFR benefit for ND patients. This seems to have been largely confirmed, although they still haven’t clarified whether it is a one-time bump or a change in slope. (At this point I suspect primarily just a bump)
b) I speculated that there would be at least a transient issue with hyperkalemia or acute dialysis in the ND trials. We will need to wait to see the FDA analysis to know.
c) I speculated that there would be an imbalance in liver related adverse events. Perhaps as mild as statin-like LFTs, perhaps more. Given that the trials made it to the end, obviously problems, if any, were on the milder end of the spectrum. But, again, we will need to wait for the FDA documents to see whether there were any imbalances of milder issues (note: AKBA recently disclosed a Hy’s Law, and their trials have nonetheless continued well beyond that event).
Quote from FGEN 18Q4 cc at end of Feb:
Just to be clear here, I am overstating my case some. But I do think there is a real possibility they have to do a big raise at a price much lower than even their current one for the reasons given. Eg id give 40% chance of a >$150M raise at an avg price under $8. And that’s a higher percent chance than I give to a similarly sized near term $ raise by selling rights or other non-stock assets.
Thanks for the response, but FWIW I was making a half flippant, half serious comment that he seems to believe in doing everything up front instead of in a way that leverages growth. (It may not hurt him, personally, too much, because he’ll always get new grants - but if he has to significantly raise again it’s going to get ugly. Not clear anyone who bought up in the 30’s can ever get well even with a $1.5B drug.)
FGEN
FGEN
FGEN AKBA and GSK
FGEN
FGEN
FGEN -
FGEN - Yep, although I grant that the results were inherently going to be messy (lots of endpoints (EMA/FDA, ND/ID/DD/SD, NI vs Superiority), that was still easily the single biggest reputation damaging event I've listened to.
They either completely do not understand what investors want to know (meet NI, superiority, or neither, and if meet only NI, is it trending better than SOC or not), or they were obfuscating heavily. Either way, not good.
AMRN