Isotechnika Pharma Inc IPHAF

RE: Another Interpretation

[WASKERWISK]

“I think this is a huge stretch, but could this be interpreted to mean that if these "several outstanding issues" are addressed, there would have been no need for a meeting? “

That would be great, but Lux doesn’t know what those issues are and isn’t expecting to know what those issues are before the action letter issues. It doesn’t seem very likely therefore that those issued can be addressed, much less resolved, before then.  And if the issues are material enough that they caused the FDA to cancel the advisory meeting then clearly the issues are of a kind that would have to be resolved before approval.

I am pretty convinced that the only thing FDA is mulling over is what to say in the action letter.  An action letter can be a formal rejection (a “non approvable” letter) but from what I can glean it can also just ask for more information (although technically they might be called the same thing) .   Either way we are looking at delay