I have been a strong supporter of Provenge. However, I also firmly believed FDA shouldn't approve Provenge back in 2007. It's very simple, FDA should NEVER approve a drug that failed predefined primary endpoint. Having worked in pharma/biotech for a long time, I can tell you if FDA opens this flood gate, every drug that failed primary endpoint can find post hoc analysis that it met other endpoint or met primary endpoint for a subset patients. The reason is very simple, every drug in phase III works for some patients. You approve a drug when it works for enough patients to meet primary endpoint, or you know for sure how to identify for whom the drug works if it doesn't work for enough patients.
Many criticism on Provenge is unfair, but at the same time, many supporters of Provenge went over board when they consider any criticism of Provenge is a "crime".
Point being, I think you really have to be in earlier rather than later with a drug like this as the Street will start to project the share price to maturity if the drug really starts to look like a winner, and it will start to do so very quicly. After that all the returns, except for trading on steep troughs may be gone.
I'd agree on this. My investment philosphy in biotech is to find undervalued early, out when it becomes fair valued or overvalued. In EXEL when BMY bailed, out after RDT result out. EXEL is fair valued at this point. I'd decide if I want to get in again before ASCO GU when more data come out. For development stage biotech, it's never straightline up. You'll get opportunity to get in. Patience, don't buy when everyone buys, buy when tons of unwarranted skepticism abound.