Biotech Values

[zipjet]

For the old timers here dew, mpower, zip etc, I'm curuoius what the percent chance you give another generic hitting the market in 2010/ 2011?

Good question.

Unfortunately, we have precious little hard data to base any prediction on. Thus, all we can do is guess, and if we are right it is just DUMB LUCK.

It does seem that Amphastar has given up. The only other applicant I am aware of is TEVA.

TEVA is still talking like they will be approved. But out of the other side of TEVA's mouth, they were arguing that total characterization was not essential. Why?

We know that the FDA moves SLOWLY and methodically. By inference, we can say that TEVA did not convince the FDA to approve their gL before MNTA did, despite a two year head start. Why?

I conclude that TEVA has fallen short. Can they fix this? How soon can they fix it? I do not know. But we are dealing in FDA-time where everything operates in slow motion.

My guess: 10% chance by EOY 2011

zip