Biotech Values

[ghmm]

ITMN:

I posted this on the other board. To add one thing to it. Paul Nobel (protocol chair) made an interesting observation and then looking at slide 21 further illustrates it. The benefit was greater in patients with more severe declines, in fact the slide shows patients with stable/improved FVC actually did better on placebo. Obviously there isn't (yet) a way of knowing which persons are at risk for more severe declines.

http://siliconinvestor.advfn.com/readmsg.aspx?msgid=25380054

I didn't quite catch it but there were big difference in non US vs US sites of the two trial (something like 80% US in one and 60% in the other).

I am disappointed with the data personally. I think it has a descent chance at approval though (just a guess obviously) with some strings attached (e.g. Phase 4 of some sort or perhaps label implying limited benefit for one year or use).

The FVC number even though it hit was less magnitude then I'ld hoped for (30ish instead of 50% ish). On the positive 6MW which the FDA likes hit in the (failed) study but trended in the positive one.

I was wrong in my prior post on size in the two trials (my math was off) the slide showed high dose were equivalent in the two trials.