Just announced today that it was not approved by the FDA. Check Com Central for the full details of the "Approvable Letter."
For me, this is unforgivable. Between the Singulair threat and the incompetence of our Leadership in most areas of our business. I am done with Merck. WTF were they doing in the studies....this drug is already a grinder and now this. And they keep spinning it, as if were imbeciles. FU MERCK!!!
Ok folks.....seriously, what went wrong with our COPD indication? Why wasn't it granted? Any thoughts out there?
Does it really matter? Sales may climb from $14 to $16 annually. Who knows, maybe we'll even get a full prescription some day and sales will skyrocket. Who is the one idiot writing this garbage? That's what I'd like to know.
Look the non-steroidal side of the combo is not the FDA's favorite. The steroidal side of the combo was never a big seller. What part of that combo was going to make a blockbuster. S-P knew that this combo was no great shakes. I don't know what Merck was thinking. Over the last 6 years I must tell you that S-P's reputation with the FDA is far better than Merck's. The number of Old Merck's shocking rejections from the FDA is stunning. Half-baked applications from legacy Merck coupled with not particularly interesting products from S-P and the merge company all adds up to some grim days ahead.
It might be better but that is not saying much. SP was on their **** list for quite a while. It was what held up Clarinex for quite a while. The FDA figured- why reward a poor performer by giving them the approval when they couldn't even get Proventil to be problem-free. Merck "merged" with this and now we all will pay the price although Merck pays the higher price because they "bought" SP. SP heads will always have a good laugh about this at Merck's expense.