50-200% seems like a good range for a n:y ratio of 6:4 or higher. We want no answers tomorrow.
Even vote will be a toss up wrt to pps action.
A negative vote will be -30% at the very most, that is cash value... No way pipeline should be rendered worthless unless the panel categorically opposes approval on grounds beyond OS data... So $4s is worse case scenario, buy on dips below that.
One of the comments that doesnt sit well with me is FDA comment :"most of the study sites were in
Eastern Europe with potentially different standard of care and practice patterns compared to
the US. Patients on the sorafenib arm of the Phase 3 study with PD could receive tivozanib on
an extension/crossover study."
Were patients in prior trials that eventually got approved in the U.S? I am no expert or pretend to be but would appreciate some thoughts on thisTIA
$15.90... cause that would be a 3x from by buy at eod. This feels like an all in bet, but I beileve we are holding AA.
The FDA is asking to consider another study because the result (while a few weeks less that another drug) is statistically identical for life extension... Someone needs to teach the FDA some math and I am OK with letting real scientists do that for me.
Sentiment: Strong Buy
With a short interest of about 15% of the float and considering it was around $8 just a few days ago, even a split panel vote could send AVEO to well over $10 ($14 ?!)
Good Luck to all the longs,,,,
I totally beleive that this drug is efficacious and safe and deserves to be approved as it covers unmet medical needs especially it was proven to show superiority over an approved drug.
To all the Longs,,, I wish you thes best cinquo de Mayo .....
I would say $14 or $8 or $4.
$14: If yes to no ratio is greater than 3 (less likely)
$8: if yes to no ratio is between 1 and 2 (more likely)
$4: if yes to no ratio is less than 1 (less likely)
Either the vote is sufficient to convince the FDA that a second study is not needed or it is not sufficient. There is no between. If the ratio is between 1 and 2, down she goes. AVEO needs a strong vote. 3 or 4 dissents may be okay. Strong positive articulation is also important. One or two very vocal dissenting members could sway a few votes and make the case for a second study even though the majority vote no study is needed. Use your judgment. If this looks iffy, get out of the way.