Interesting review of approval chances of Ibalizumabhttps://www.healthonym.com/ibalizumab-trogarzo-therf-taimed-theratechnologies/ Most of this article looks good and the info is well known by this board. The 3 "concerns" are probably of most interest to people here.
My thoughts
1) I hadnt thought about this aspect of monoclonals although I think in the situation where you have MDR and virological failure with limited drug choices its a no-brainer that the drug will be a potential life-saver. Its possible if this a worry for FDA that they may reserve this for IM version, IDK.
2) The weakness in this argument would be that the FDA have been invovled with this drug for a long time and trial design will have had had some input from FDA, to some extent they'd be rejecting their own advice.
3) They note this concern is rather weak, I dont see potential resistance being an issue.
Overall I'd say non of this was identified at the time of the extension and if they did exist you would think that they would have been raised by then. My only concerns revolve around the manufacturing issues that caused the delay but it's interesting to see critical reviews like this.
(I know nothing about this website)