I AM NOT A FINANCIAL ADVISER! This is my attempt to better understand the cause/effect relationship of FDA Advisory Committee (AdComm) meetings on BioTech/Pharm stocks. This is for my own education, not to serve to advise or recommend any path for others. If looking for advice look elsewhere. If trying to understand the same stuff I’m trying to understand, please draw your own conclusions… mine are nuts, and would likely put you in the poor house.
- Novartis already trading higher than I like, > $80
- Novartis and Roche face fines in Italy for alleged collusion
- Phase II trial data as presented looked good… a good solid cancer drug could be a giant win
- Japan not crazy about allegedly exaggerating drug claims
- OUCH! From FDA Briefing Info doc: We recommend that serelaxin not be approved at this time because there is insufficient
evidence to support the proposed indication: to “improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure”.
- I’d say I’m pretty-well out on this one, folks
- Panel voted 0-11… Recommend Rejection
|Date||Open||High||Low||Close||Change from Prior|
- Inexplicably, the markets did not appear to notice that the Materials were published today, and the FDA docs recommend to NOT approve. My world is shaken… but not stirred.
- Inexplicably, the markets did not appear to notice when AdComm voted to not recommend Approval today, though they only had a few minutes until close… we’ll see what tomorrow brings.
- Day after… still nuthin’.
- Nothing to see here.
- I’m not going to dignify this with a summary.