| | | Do you like CEO Hatfield any better? His high level employees have all been there a while, so if you didn't like them, as well as not liking Hughes, than maybe there's still a trust issue here, even if you're OK with his track record. I saw the tweet about d-dimer levels, and that's helpful, and adds to the temptation to play the possibility of a lift of the hold. So thinking out loud . . . if Leerink's Schwartz' concern about drug metabolism and drug-drug interactions is shared by the FDA, might they get just a partial lift soon, only to do a study that addresses that? It seems like a fairly major concern. If that's the next regulatory news, I don't think the stock will react that well. OTOH, if they are allowed to measure other stuff, like efficacy, at the same time, that might cushion the blow. The home run scenario would be if the d-dimer and other data to date plus the possible similarity to beloranib wrt to drug-drug interactions and metabolism (but not, of course, the tox that torpedoed that compound) results in a green light to resume the P2 trial in full, doing the interaction study in parallel. I haven't looked to see if that sort of data for beloranib is around, and I probably wouldn't get to it till this weekend at earliest.
Anyway, that covers about all the scenarios :>) Considering the history, the most reasonable approach from FDA's perspective would be an interaction study first. It's not like there's a huge unmet need here; there are somewhat effective treatments, so I'd expect the FDA to be prudent. How the stock would react to that, I'm not sure, would probably depend on how long said study would take. A year, or maybe two, at worst? That's like, forever, while the company pays the overhead of executive thumb twiddling in the meantime.
Dunno if there's shutdown impact here.
Even if not, my guess is dead money for a while, maybe worse if they have to raise before results of said study.
Interested, but staying away (FWIW, though I've posted about Zafgen before, I never had a position of any kind).
Cheers, Tuck |
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