IMHO, if the FDA was to reject if would have done so. It seems to me that the FDA and TH are negotiating the details such as labeling, risk management, follow up studies, etc. Now we have a 2-5 month delay. I can wait this on out.
With the unanimous panel decision, WHY would the FDA extend the approval in the 4th quarter? I don't understand the delay.
I would agree with that assessment. What do you anticipate the FDA approval will bring to the stock price assuming a 1.3 billion pipeline?
JMHO, like $8 to $12. That could go up if a good European deal is made. But my guess is Merck will buy them out within 6 months after approval.
I agree. They may want some warnings on the packaging as to possible side effects such as joint swelling and pain.