Replies to post #165991 on Biotech Values

[poorgradstudent]

ARQL:

Also, how did they come up with the conclusion to reduce to 120 mg?

Might be related to the tablet dosages they have available.

[caravon]

Let us sum Tivantinib data:
- Tiva's Ph3 HCC AEs @ 240 mg were not expected based on prior data
- ARQL has very limited 2nd-line HCC experience @120 mg
- All options were considered and decided to go forward with the HCC Ph3 trial carefully watching AEs signals. Remember that 2nd-line HCC MET-high pts have OS just ~4 months. These pts are very fragile. [My guess is that HCC AEs @120 mg will be mild. Cannot even guess about efficacy.]

- ARQL has more than 1,500 NSCLC pts (Ph 1,2, and 3) who got 360 mg without serious AEs problems. AEs were very mild. Japanese NSCLC trials are also in progress.
- No other independent-investigator Ph2 trials @ 360 mg (in BC, CRC, PC, etc.,) reported any serious AEs problems and/or were stopped.

Well,
- the Marquee presentation at ESMO in 3 weeks will provide very important info about Tiva future. Specifically, watch for sub-groups OS and AEs results in MET-high pts.
- ARQL/Daichii did not properly designed and executed Ph2 trials