I say 90% vote yes and 10% vote no or stay neutral
1. primary endpoint achieved
2. safety is good
3. secondary endpoint is influenced due to the crossover, meaning patients change to Tivo which is better tolerated and doesn't induce as much dose changes as all other medication.
Why would patients crossover?
A. Because they feel terrible (side effects) and/or are getting worse. In both cases they think as Tivo being their last chance to survive.
B. We all know there were more patients changing towards Tivo than the other way. Considering the less healthy patients changing to Tivo, I find it truly AWESOME that Tivo did NOT show statistally significant more deaths. On the contrary Tivo showed statistically equal OS.
C. Tivo will be administrated as best in it's class and I think that market penetration will be very easy with these excellent results.
Sentiment: Strong Buy
67% crossed over to TIVO, meaning these patients consider Tivo as their last chance to survive, meaning they were in the worst condition possible. It is truly great that Tivo succeeded not to show statistical less overall survival than the medication to which it was compared.
In consider this secondary endpoint as a success instead of a failure and Adcomm members will consider it too.
Sentiment: Strong Buy
I am really puzzled how negative the sentiment is.... while volume has picked up, it seems that the market is scared and has little faith in TIVO.... biotechs have been up and yet AVEO is stuck under $7.50. I imagine that with a positive ODAC review the stock will shoot up to $12-13....perhaps even $14? what is everyone else expecting with positive ODAC?
people are waiting to see the list of questions the panel will be asking and how negatively they are worded. In some cases, when this list has been made public, the stock goes down, sometimes dramatically.
$14 like before the OS data which is clearly wrongly interpretated by shorters (see my comment above). And after FDA approval I expect the share price somewhere between $14-$18 based on the maximum +$1,6B milestone payment (worth $25/share)
For next week I expect that shorters will be leaving their positions. I expect a high spike if Adcomm is positive on May 2nd, where shorters will retake their positions on top of the spike until some days before FDA decision time.
Not for Tivo, because they asked and showed to be administrated as best in it's class.
I find it also reassuring that they partnered with a big pharmaceutical company which has sufficient influence to let the Adcomm jury have their decision based on the study results. (Which has not happened with Zogenix and AP Pharma recently on the FDA decision)