Whatever, I'm not going to mess up our good relationship arguing over semantic fine points. Jon's point about the SPA is telling about someone; I'm just not sure yet if it's telling about Givens and ENCY or the FDA.
Edit: Market surveillance? kenhott has also said he thinks the players know what Thelin's problem with the FDA is, if that's what you mean. I'm not so sure. There hasn't been a filing for PAH since tracleer; if the FDA's attitude changed since then (and perhaps since issuing the SPA to ENCY) the folks with the best take on that are ENCY. I do not know to what extent GILD/MYOG might be talking to the FDA at this point, in advance of their actually filing. Maybe, they are talking a lot and have indeed figured out this attitude change or "philosophical difference" that Givens won't tell us about. Maybe you're right not to buy the "competitive reasons" argument. I'm not swallowing it hook, line, and sinker, myself, but I'm not utterly pooh-poohing it, either. Anyhow, I'll be watching the Ambrisentan regulatory process with great interest, even if I no longer have a position in ENCY when it happens.
Edit, to Idos: How low can it go? If it's really only a few weeks delay, $5. If you feel it utterly destroys ENCY's already tipsy credibility, then $4, since they DO have Thelin approved in EU and got the stalled trial going again (but that rat doesn't help their credibility/perception of competence at all, I must say; that's got to be the stupidest thing I've seen them do).
Cheers, Tuck |
