“For instance, NASH he can say whatever he wants
Post# of 148187
We can agree to disagree. I don’t believe NP could keep quiet if the FDA has hinted at combo and mono approval at the same time. There’s now way. He shared that they asked for more safety data, that they wanted 50 patients but now all 595, and remember that he shared a verbatim quote from the FDA about wanting to get leronlimab approved (it said something like that).
Now, I don’t disagree that combo and mono should be approved within a short time of each other. Data from 600 monotherapy patients and the additional data from the combo trials, in combination with leronlimab’s safety profile, should be more than enough to get approved. I hope there’s some truth to the idea, but I don’t believe,Ike the article hints at, that NP is hiding this big secret that combo and mono approval is coming soon and at the same time.