Pom will be approved in days & will launch more quickly & sell faster than many estimate
It is disappointing that the FDA is taking its time - as in early November the FDA cancelled the Pom panel review as all questions have been answered, the company has discussed the data for a very very long time and the Ph 3 EU trial with stunning OS and PFS benefit seals the deal (although a trial with a high dose dex comparator arm would never be run in US). Still you have to believe that the FDA is taking their time as this is a Ph 2 trial - perhaps to say they really reviewed it since its such an accelerated review. In their mind, they are approving yrs early, not slowly. The REALLY exciting news is this drug is going to be approved 2 yrs earlier than originally expected in Europe. This is bigger than people think.
Still onxx Ph 2 drug was approved before PDUFA so it may be time. Lets hope they try to sneak one more approval in January today to get the yr off to a good start or at the very least start Feb off quickly with a Feb 1 approval on normal busy Friday FDA day.
To me Pom is being underestimated. The company is CLEARLY ready to launch - I suspect they will have this drug on pharmacy shelves within days of approval and we will get 1 1/2 to 2 full months of Pom sales to help normally tough Q1 - and my gut says analysts have nothing in Q1 for Pom. Launches sometimes take time - but Pomalyst has about as much awareness as I have ever seen in MM KOLs - with them really hoping for approval in 2012 and ready to use per Richardson, Anderson, NCCN discussions etc. It a VERY VERY powerful MM drug. And it works in Revlimid and Velcade failures. IMO Pom is not fully priced in CELG stock at $100. Its like that old Fram oil filter commercial.....
"Any Day Now" ........"You can Pay me now or Pay me later"
Right on Rob, thousands waiting for Pomalyst, a game changer, Feb 8 should have happened long ago.
"Our commercial and medical affairs teams are ready to launch and support the thousands of patients who have exhausted all existing myeloma therapies," Celgene Executive Vice President Mark Alles said. "Successfully launching Pomalyst is a major corporate objective and we are ready."