IMO--affy current market price at $ 5.13 fully priced for the potential negative BS from FDA----market price approximates 90% of cash value per share---so the risk portion is maybe $.50 to $ .65 per share
On the other hand why did Amgen prempt the decision with that 7 year deal--my gut says there is so much negative it behooves everybody to watch this stock double if all green lights are on
The core AFFY institutional ownership is blue blood and they usually have an edge in knowing quality which drives me to buy more today
IMHO, they have a reasonable chance at approval due to pharmaceconomic concerns at Medicare. Believe it or not, Medicare is the biggest behind-the-scenes lobbyist at the FDA, an agency that proclaims science, but sometimes makes arbitrary and capricious decisions when it comes to drug approvals. AMGN is obviously concerned about a new competitor, as they already have problems with the AMGN-JNJ Erythropoietin oligopoly. However, there are only so many Medicare dollars to around, so anti-trust issues surface. Medicare clearly wants generics, competition, etc. so the prices of these expensive drugs comes down. AMGN may think they have tied up the market with their recent contracts, but in offering to match the prices, they've already brought down future prices.
this is a good post, but a negative outcome/significant delay, or outright rejection is not priced in. AFFY can go a lot lower if rejected and Takeda bails. As AF said, the data look adequate, or similar. The FDA review on Monday will probably look negative, it usually does, so there may be a change to buy lower on Monday morning for those interested. FDA is always a risk, but the efficacy is similar and safety as good in the intended patient population with the portneital for pricing and convenience improvement.