Too bad Incyte did not use this information from the Comfort studies , instead of the relief studies. Now only if we could get some NEW people into this stock, it may just get back up to 50.
This is only huge. FDA rarely allows results of post-facto analysis onto drug labels. Detailers can now point to the diverging curves and suggest earlier use of Jakafi in minimally-sick MF patients.
Consider the difference: before, salespeople were only allowed to tell physicians that if they contacted the company they could get more references to clinical data. If FDA had allowed references onto the label, the salespeople could have carried reprints with them, but they'd have been on shaky ground discussing the findings. With the curves on the label, they can basically tell the whole story.
And certain annoying people who keep saying "It only relieves symptoms" can choke on their own bile.
they did discuss the royalty to NVS on an earnings call... I do not recall the number of countries needed to start however...or if was even mentioned.
#1 is hard, but just barely possible. #2 is unlikely--FDA doesn't schedule stuff for ANYONE's convenience. #3 is pretty much impossible, as Italy is on vacation and NICE, again, isn't scheduling actions for our convenience.
Other than that, I think #s 2&3 are pretty much non-events. Europe ex-UK and IT (&ex the already onboard DE and FR) is on the same order of size as either one of those, so the rollout can keep going without them; the $60MM is modest next to the numbers that are really interesting to people. And the money question for PV is whether adding the less-serious indication can increase the dollars of sales, not whether it can be added at all.
What (if any) sales use can be made of papers showing a MF survival benefit for Jakafi is potentially of great interest; any kind of recognition of post-facto analyses would have symbolic importance.
There's a curious tripwire hiding somewhere--some number of country approvals of Jakavi starts up a reverse royalty to Novartis, which I don't people have front-of-mind.
Slow down , why is GERN $3.00 , I hold both ,not buying more of any stock , market is ????
Hahaha, I see you are a right IDIOT, you have no clue what the drug you are invested in does. These are the facts BOZO...no disease modifying activity...please point me to ONE trial that suggests otherwise...
Yes I get the fact you're short & bashing the stock. But you're still an IDIOT. I'm looking forward to FDA approval of the same placebo drug for treatment of PV by years end. Should bring PPS back into the $60s. I suggest you don't cover until after FDA approval.