There's been a run up from about 11-12 to the high 14's in the past 4 weeks. I'm guessing that the run up has been in anticipation of FDA approval. I was wondering if you guys could propose other scenarios other than complete approval, and what their impact might be.
I was a little padawan investor back in the day that IMGN was told that it wouldn't get FDA fast tracked, and it fell from 9 to 6 dollars in a day. I lost my shirt that day since I was leveraged into it. But I digress. Here are a few scenarios I could imagine.
2) faster than expected approval
3) No verdict and a need for more time.
4) Additional Data needed for decision
5) Complete rejection
Why did you sell after the 2010 RTF? That was a GREAT buying oportunity!
Approval is basically priced in here, IMHO.
A delay hardly matters, but could be a quick trade oportunity. Actually, there is a slight beni to the financials if a delay does happen (that was one reason why the 2010 delay was actually good). The reason is the 12 year clock is delayed also, but full market potential is not.
TDM1 will be approved, the FDA would look like idiots to hold it up any longer at this point. I imagine the discussion at this point is what the label is going to read and how much the FDA is willing to compromise on without having complete phase III data in hand from ongoing trials.
The label won't matter that much initially anyway as oncology doctors will likely adjust their diagnosis of their patients MBC in order to give TDM1 is they feel that is the best course of treatment for them.
One thing that could potentially scare people off when approval is announced is how much Roche is planning to sell TDM1 for. It should be an will be a premium over Herceptin, how much? Other recent drug approvals that came with some pretty steep costs were not received that well at first, SGEN is a good example. I am guessing between a 20-30% premium over current Herceptin costs.
Compared to other FDA approved cancer drugs in recent years, an approval for indication for th treatment of 2L Her2 mBC is a sure thing. I suspect FDA will very likely grant an approval for 1L as well for this application because Roche's application includes very strong ph2 data supporting the 1L treatment, requiring Roche to complete the 1L pivotal trial.