Hmmmm I couldn't help but note the rather forthright tone of CB's comments regarding labelling. Well done that poster who pointed out this may be a sticking point. Maybe it is.
I can't help but think that "a well defined set of manufacturing related observations" means "we had to fix something".
On the other hand, it's clear that CB is prepared to be seen as optimistic about the process. The last two sentences of the quote ("no new data" and "bring to patients") are clearly designed to try and reassure everyone.
It's not at all great, but Delay is better than No.
So they're now promising two big ticket results by EOY. Firstly, the delayed imaging trial which CB assures us will still get to the FDA as expected. Now the Illucix NDA. But the other thing which is really important to get rolling is the US therapy trial.
These are the three big ticket items which need to get successfully knocked over and will show that the company is on track.
Ann: FDA Extends New Drug Application Review Period for Illuccix, page-8
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