well it looked like we were going to make it thru summer 2012 with the normal arql summer disaster but no, never too later for arql to pop up and land a wallop. of course one issue is that kyowa operates arm's length from arql so arql probably knows as much as we know at this point. very strange situation: how can they suspect tiva of causing ild and not end the study until the analysis is complete? how long will it take to do the analysis? and with all the studies ds/arql have done to date no indication of this issue...is there possibility this could pop up with marquee or would they have identified it already? anyway now we have cloud over tiva until this is resolved, regardless of what mid-term data is released. I see they're planning to present at stifel conference next week...they better have some answers...this is the ONLY item investors will want answers about. situation is bizarre...any predictions for tomorrow? actually considering the situation, a 19% drop is not disastrous...but who knows what the next few weeks holds. btw...it's know tarceva can cause ild but who knows what they'll find.
The situation is very simple:
* ARQL has no control and/or any say in Kyowa Hakko Kirin Ph2 NSCLC trial. They did not do a Ph2 trial. So, their data base is very limited in Asian pts. One more time for a "slow" people: the US Ph3 and the Asian Ph3 are trials for somewhat different cancers. It might take 4-6 weeks for Kyowa to do their review. Quite possible, Tiva will be used in Asia NSCLC pts with some additional biomarkers.
* ARQL did not have any safety problems with their NSCLC trials. This is the important fact so far. The interim Ph3 NSCLC data will be available in ~ the next 60-90 days. This set of data will tell a lot. The rest are just guesses & speculations.
Did you noticed in the press release about upcoming conferences that Arqule didn't mention Kyowa Hakko Kirin as a development partner for Tivantinib?
In recent months Arqule didn't mention in their press releases other drugs in the pipeline. They did in this press release. They probably want investors to know that there are other drugs, although in early development, in coming along. Does this concern anyone? The stock is probably stuck just north or south of $5 a share until some positive data is released on Tivantinib.