Replies to post #169157 on Biotech Values

[biomaven0]

It would be close call based on the data we have now.

If they were going for true 3rd-line (T315I or failed both 2nd line drugs) then I am pretty sure the FDA would approve. The only alternative for these patients is a transplant, which has considerable mortality and morbidity. Doctors can take care of the titration themselves - just use the lowest dose that works. That's not something you can really find out from trials within a small population - each patient is different.

Peter

[iandy]

If trials had used dose titration method similar to Jakafi for MF, it would be easier to get approval because there would be more data for various doses.

jq - You and Peter were talking about dose titration well before this thing blew up. Isn't dose titration essentially what they do in phase 1? Why wouldn't they automatically try it in Phase 2 for drugs like this? It's not like it's a new unproven idea. It is common practice with Tylenol for Christ's sake.