Replies to post #98630 on Biotech Values

[BTH]

Might want to atleast wait until a larger phase 2 blinded study before proclaiming the drug works.

Don't really know if you've been following the P1 study.

They're going directly into a Pivotal Phase 2 study with '534. Considering they will likely get a Ophan status for this drug in the T315i portion of CML patients, I believe it will be granted an expedited approval (much like Gleevec was).

They're not going for "front line" which would take a longer trial as you suggest.

[biomaven0]

Also it's a bit early to be saying 534 works since they have only done a phase 1 trial!

There is no question that the drug works and works well - read the ASCO presentations for yourself if you don't believe me. What still remains to be seen is whether it can move up from 3rd line over time or not.

Peter

[BTH]

BTW, FWIW, I didn't say 2011, hard.

I said 2011-2012.....2011 would be based on results similar to Gleevec's approval. 2012 is probably more reasonable.

Considering Ariad is not going for "front line" but all resitant forms, they likely can get an expedited approval.

I highly doubt there is going to be any head-to-head, or placebo study in the pivotal trial they are going to run

[rkrw]

I guess reseach doesn't play much of a role in your strategy.
534 is heading into a registration study that shouldn't take all that long to enroll and complete, maybe 12 to 18 months. If the data is clear, a review should be a formality. But we'll have to see if it's as easily said as done.