Biotech Values

[poorgradstudent]

Re: INCY

Friedman is a bit of a blowhard, but nonetheless here is my quick transcript of his comments regarding the recent letter in the NEJM:

""there are some pretty squirrely letters in the nejm … we know the data in that "screed" and the fda knows it. We've analyzed that data upside and down… we will show you all the data and you'll see it supports ruxolitinib. Won't talk about it in the middle of the NDA review. Top line points: it shows that if you don't keep your patients on the drug, their symptoms will come back and spleens begin to grow again. We'll show you how many came off when and it'll be an eye-opening result. Secondly, if you don't give enough drug, you won't get a maximally effective response. Thirdly, if you did not keep your patients on drug for a decent length of time, and then you used them as subjects for a survival curve, the results are fairly meaningless. Lastly, wrt the 5 sick patients who were hospitalized when they stopped drug, you can find several of them in the appendix to the nejm paper (where they were also authors)… we took those cases very seriously when we designed phase 3 and looked closely at possibility of a withdrawal syndrome. We found not a whiff of evidence for withdrawal syndrome in the phase 3 trials. "


fwiw... obviously he's going to defend his drug.