the CRL was soft, manufacturing related. should get review within 2 months and early approval
Sentiment: Strong Buy
FDA is not predictable. It could be 6 months away. Risk is always involved with FDA.
I made this exact same point back in April when I said we'd be looking at a December or even early 2015 FDA decision. Now at least we all know that we are looking at dead money for 6 months, possibly longer.
Is your price target of $12.50 the target immediately after approval?
I agree with that, but by year's end it will be $15 plus.
It depends on Vimovo sales and ROW partner.