Replies to post #27004 on Biotech Values

[RockRat]

>>Why are you interested in the 18-week safety data, specifically?<<

Because both Tracleer and Thelin demonstrated similarly benign effects on liver enzymes at 12 weeks. I suspect that they will show up in that timeframe for Ambrisentan, as well. It was in the 12 to 18 week period that those liver enzyme elevations started showing up for both of them (somewhat less for Thelin).

>>According to today’s PR, MYOG now has a safety database of 400 patients from long-term studies (up from 200 at the time of the ARIES-2 PR).<<

MYOG may have this data in their long term safety database, but they don't seem to be interested in sharing it with us.

>>Which do you think will be the primary dose for the NDA: 5mg, 10mg, or equal billing?<<

I further suspect those effects are dose dependent for Ambrisentan, and as such, I'd reckon they'd go with 5mg dose, which seems to be the optimal one for Thelin, too. I basically think that they're going to be very similar in terms of clinical relevance. I was betting on ENCY having "second mover" advantage, given that it has a slightly better safety profile than Tracleer, but we know that's mostly gone. Since MYOG's efficacy data are a bit muddied now, the 18 week safety data is their only chance to differentiate it. Since they haven't come forward with it in a flowery PR, I'm guessing it ain't that great.

Regards, RockRat